NCT02531633 is a Phase 3 clinical trial of Sirukumab in Giant Cell Arteritis, sponsored by GlaxoSmithKline.

Who is sponsoring NCT02531633?

NCT02531633 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT02531633?

Interventions in NCT02531633: Sirukumab, Placebo to match sirukumab, Prednisone, Placebo to match prednisone.

What condition does NCT02531633 study?

NCT02531633 studies Giant Cell Arteritis.

Is NCT02531633 still recruiting?

NCT02531633 is currently terminated. Last updated 31 July 2019.

Are results published for NCT02531633?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-07-31 · How we verify

NCT02531633

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis

Terminated Phase 3 Results posted Last updated 31 July 2019

What this trial tests

Phase 3 trial testing Sirukumab in Giant Cell Arteritis in 161 participants. Terminated before completion.

Timeline

16 October 2015

Primary endpoint
21 March 2018

21 March 2018

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	161
Start date	16 October 2015
Primary completion	21 March 2018
Estimated completion	21 March 2018
Sites	63 locations across France, Italy, Netherlands, New Zealand, Belgium, United Kingdom, Germany, Hungary

Drugs / interventions tested

Sirukumab — full drug profile →
Placebo to match sirukumab — full drug profile →
Prednisone (prednisone) — full drug profile →
Placebo to match prednisone — full drug profile →

Conditions studied

Giant Cell Arteritis — all drugs for Giant Cell Arteritis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

50 and older, any sex, with Giant Cell Arteritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part A: Number of Participants in Sustained Remission at Week 52 Primary · Week 52

Sustained remission was defined as having achieved all of the following: 1) remission at Week 12, 2) absence of disease flare Week 12 through Week 52, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of erythrocyte sedimentation rate (ESR) \[\<30 millimeters per hour\] and C-reactive Protein (CRP) \[\<1 milligram/deciliter\]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	3
PartA:SIR 100 mg SC q2w+3 Month Prednisone	2
PartA:SIR 50 mg SC q4w+6 Month Prednisone	1
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24 Secondary · Week 24

Participants who remained in sustained remission without requirement for rescue therapy or treatment change at each scheduled visit of Part B were defined as participants having achieved all of the following criteria: 1. Participants in sustained remission at the Week 52 visit of Part A, 2. Absence of disease flare, 3. No requirement for rescue therapy at any time through Week 24 of Part B, 4. No requirement for treatment change at any time through Week 24 of Part B. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR \[\<30 millimeters per hour\] an

Group	Value	95% CI
PartB:SIR 100 mg SC q2w+6 Month Prednisone	NA
Part B:SIR 100 mg SC q2w+3 Month Prednisone	NA
PartB:SIR 50 mg SC q4w+6 Month Prednisone	NA

Part A: Cumulative Prednisone Dose Over Time Secondary · Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Cumulative prednisone is the dose from the taper (both open-label and blinded) as well as from the corticosteroid rescue therapies. Cumulative dose at the specified Week was derived as the sum of all the doses from Baseline to the specified Week at each visit was calculated based on the number of participants who attended that visit. For the main analysis of cumulative prednisone dose over time. Data for Prednisone Dose- Study Drug and Prednisone Equivalent Concomitant Therapy for part A is presented. ITT population and the number of participants included at specific time points were based on

Week 2, n= 40,39,26,27,26

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	439.575	± 237.8990
PartA:SIR 100 mg SC q2w+3 Month Prednisone	464.923	± 299.6445
PartA:SIR 50 mg SC q4w+6 Month Prednisone	424.577	± 270.2183
PartA:Placebo SC q2w + 6 Month Prednisone	432.815	± 315.6851
PartA:Placebo SC q2w + 12 Month Prednisone	430.846	± 241.3540

Week 4,n=40,39,26,25,27

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	701.100	± 370.9798
PartA:SIR 100 mg SC q2w+3 Month Prednisone	741.115	± 436.4205
PartA:SIR 50 mg SC q4w+6 Month Prednisone	701.192	± 439.7251
PartA:Placebo SC q2w + 6 Month Prednisone	705.480	± 601.9706
PartA:Placebo SC q2w + 12 Month Prednisone	751.407	± 431.3442

Week 8,n=37, 37,26,23,26

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	1086.676	± 600.7400
PartA:SIR 100 mg SC q2w+3 Month Prednisone	987.730	± 559.4458
PartA:SIR 50 mg SC q4w+6 Month Prednisone	1014.731	± 592.3515
PartA:Placebo SC q2w + 6 Month Prednisone	1161.391	± 1202.8504
PartA:Placebo SC q2w + 12 Month Prednisone	1129.077	± 546.8037

Week 12,n=34,32,24,22,24

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	1344.441	± 779.6775
PartA:SIR 100 mg SC q2w+3 Month Prednisone	1063.773	± 619.4002
PartA:SIR 50 mg SC q4w+6 Month Prednisone	1208.167	± 650.6975
PartA:Placebo SC q2w + 6 Month Prednisone	1379.409	± 1255.4397
PartA:Placebo SC q2w + 12 Month Prednisone	1462.917	± 630.1717

Week 16,n=32,30,24,22,22

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	1545.602	± 964.3264
PartA:SIR 100 mg SC q2w+3 Month Prednisone	1182.288	± 718.6186
PartA:SIR 50 mg SC q4w+6 Month Prednisone	1348.750	± 689.2484
PartA:Placebo SC q2w + 6 Month Prednisone	1672.795	± 1261.7121
PartA:Placebo SC q2w + 12 Month Prednisone	1729.977	± 701.3734

Week 20,n=29,27,21,24,19

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	1690.302	± 1173.6005
PartA:SIR 100 mg SC q2w+3 Month Prednisone	1339.546	± 888.5007
PartA:SIR 50 mg SC q4w+6 Month Prednisone	1475.786	± 734.7667
PartA:Placebo SC q2w + 6 Month Prednisone	1646.177	± 701.5240
PartA:Placebo SC q2w + 12 Month Prednisone	2041.632	± 771.3504

Week 24,n=30,25,19,18,17

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	1878.458	± 1333.1175
PartA:SIR 100 mg SC q2w+3 Month Prednisone	1495.015	± 1055.9615
PartA:SIR 50 mg SC q4w+6 Month Prednisone	1626.342	± 813.8284
PartA:Placebo SC q2w + 6 Month Prednisone	1917.444	± 861.6887
PartA:Placebo SC q2w + 12 Month Prednisone	2299.471	± 840.8758

Week 28,n=24,23,15,17,15

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	2000.813	± 1594.5982
PartA:SIR 100 mg SC q2w+3 Month Prednisone	1575.549	± 1170.7294
PartA:SIR 50 mg SC q4w+6 Month Prednisone	1797.533	± 933.3753
PartA:Placebo SC q2w + 6 Month Prednisone	2141.294	± 1082.2754
PartA:Placebo SC q2w + 12 Month Prednisone	2387.800	± 741.1663

Part B: Number of Participants in Sustained Remission Over Time Secondary · Weeks 4, 8 and 12

Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR \[\<30millimeters per hour\] and CRP \[\<1milligram/deciliter\]) and Flare was defined as recurrence of symptoms attributable to a

Week 4,n=1,1,1,0,0

Group	Value	95% CI
PartB:SIR 100 mg SC q2w+6 Month Prednisone	1
PartB:SIR 100 mg SC q2w+3 Month Prednisone	1
PartB:SIR 50 mg SC q4w+6 Month Prednisone	1

Week 8,n=1,0,1,0,0

Group	Value	95% CI
PartB:SIR 100 mg SC q2w+6 Month Prednisone	1
PartB:SIR 50 mg SC q4w+6 Month Prednisone	1

Week 12,n=1,0,0,0,0

Group	Value	95% CI
PartB:SIR 100 mg SC q2w+6 Month Prednisone	1

Part A: Time to First Disease Flare After Clinical Remission Secondary · Week 52

Clinical remission was defined as absence of clinical signs and symptoms of GCA, which was determined by a lack of flare for the participant. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to first disease flare (days) was calculated as (Date of First Flare - Date of Clinical Remission + 1 day). Data for Time to first disease flare after clinical remission for part A is presented.

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	NA	NA – NA
PartA:SIR 100 mg SC q2w+3 Month Prednisone	NA	NA – NA
PartA:SIR 50 mg SC q4w+6 Month Prednisone	NA	176.0 – NA
PartA:Placebo SC q2w + 6 Month Prednisone	NA	99.0 – NA
PartA:Placebo SC q2w + 12 Month Prednisone	NA	183.0 – NA

Part B: Time to First Disease Flare for Participants in Sustained Remission Secondary · Week 52

Clinical remission was defined as absence of clinical signs and symptoms of GCA. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to event (days) is defined as the duration in days from the date of the Week 52 visit of Part A to the start date of Event (Date of First Flare - Date of Week 52 visit of Part A + 1). Data for Time to first disease flare after clinical remission for part B is presented.

Group	Value	95% CI
PartB:SIR 100 mg SC q2w+6 Month Prednisone	NA	NA – NA
PartB:SIR 100 mg SC q2w+3 Month Prednisone	NA	NA – NA
PartB:SIR 50 mg SC q4w+6 Month Prednisone	NA	NA – NA

Part A: Number of Disease Flares Over Time Secondary · Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants; participants who did not reach Week 2 were not included in this analysis. Data for number of disease flares per participant over time for part A were presented.

Week 2, n=38, 39,26,25,27

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	1
PartA:SIR 100 mg SC q2w+3 Month Prednisone	2
PartA:SIR 50 mg SC q4w+6 Month Prednisone	2
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	2

Week 4, n=37,37,25,23,27

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	3
PartA:SIR 100 mg SC q2w+3 Month Prednisone	4
PartA:SIR 50 mg SC q4w+6 Month Prednisone	3
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	2

Week 8, n=34,32,24,23,23

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	2
PartA:SIR 100 mg SC q2w+3 Month Prednisone	6
PartA:SIR 50 mg SC q4w+6 Month Prednisone	3
PartA:Placebo SC q2w + 6 Month Prednisone	1
PartA:Placebo SC q2w + 12 Month Prednisone	5

Week 12, n=32,29,24,22,22

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	4
PartA:SIR 100 mg SC q2w+3 Month Prednisone	9
PartA:SIR 50 mg SC q4w+6 Month Prednisone	4
PartA:Placebo SC q2w + 6 Month Prednisone	4
PartA:Placebo SC q2w + 12 Month Prednisone	4

Week 16, n=28,26,22,19,19

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	4
PartA:SIR 100 mg SC q2w+3 Month Prednisone	9
PartA:SIR 50 mg SC q4w+6 Month Prednisone	5
PartA:Placebo SC q2w + 6 Month Prednisone	9
PartA:Placebo SC q2w + 12 Month Prednisone	4

Week 20, n=26,23,19,18,16

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	4
PartA:SIR 100 mg SC q2w+3 Month Prednisone	9
PartA:SIR 50 mg SC q4w+6 Month Prednisone	6
PartA:Placebo SC q2w + 6 Month Prednisone	10
PartA:Placebo SC q2w + 12 Month Prednisone	3

Week 24, n=23,21,16,17,16

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	6
PartA:SIR 100 mg SC q2w+3 Month Prednisone	9
PartA:SIR 50 mg SC q4w+6 Month Prednisone	8
PartA:Placebo SC q2w + 6 Month Prednisone	11
PartA:Placebo SC q2w + 12 Month Prednisone	5

Week 28, n=19,18,12,14,14

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	5
PartA:SIR 100 mg SC q2w+3 Month Prednisone	8
PartA:SIR 50 mg SC q4w+6 Month Prednisone	8
PartA:Placebo SC q2w + 6 Month Prednisone	11
PartA:Placebo SC q2w + 12 Month Prednisone	5

Part A: Number of Participants With at Least One Hospitalization for Disease Flare Secondary · Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Number of participants with at least one hospitalization for disease flare at a given visit is the number of participants with at least one hospitalization for disease flare between first SC IP intake and the day of the given visit. Data for participants requiring at least one hospitalization for disease flare for part A is presented.

Week 2, n=38, 39,26,25,27

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	0
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0
PartA:SIR 50 mg SC q4w+6 Month Prednisone	0
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Week 4, n=37,37,25,23,27

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	0
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0
PartA:SIR 50 mg SC q4w+6 Month Prednisone	0
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Week 8, n=34,32,24,23,23

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	0
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0
PartA:SIR 50 mg SC q4w+6 Month Prednisone	0
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Week 12, n=32,29,24,22,22

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	1
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0
PartA:SIR 50 mg SC q4w+6 Month Prednisone	0
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Week 16, n=28,26,22,19,19

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	1
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0
PartA:SIR 50 mg SC q4w+6 Month Prednisone	0
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Week 20, n=26,23,19,18,16

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	1
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0
PartA:SIR 50 mg SC q4w+6 Month Prednisone	1
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Week 24, n=23,21,16,17,16

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	1
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0
PartA:SIR 50 mg SC q4w+6 Month Prednisone	1
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Week 28, n=19,18,12,14,14

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	0
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0
PartA:SIR 50 mg SC q4w+6 Month Prednisone	1
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Part A: Number of Hospitalizations for Disease Flare Over Time Secondary · Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Number of hospitalizations for disease flare at given visit is the number of hospitalizations for disease flare between first SC IP intake and the day of the of the given visit.. Data for number of hospitalizations for disease flare over time for part A was presented.

Week 2, n=38, 39,26,25,27

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	0
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0
PartA:SIR 50 mg SC q4w+6 Month Prednisone	0
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Week 4, n=37,37,25,23,27

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	0
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0
PartA:SIR 50 mg SC q4w+6 Month Prednisone	0
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Week 8, n=34,32,24,23,23

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	0
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0
PartA:SIR 50 mg SC q4w+6 Month Prednisone	0
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Week 12, n=32,29,24,22,22

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	2
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0
PartA:SIR 50 mg SC q4w+6 Month Prednisone	0
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Week 16, n=28,26,22,19,19

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	2
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0
PartA:SIR 50 mg SC q4w+6 Month Prednisone	0
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Week 20, n=26,23,19,18,16

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	2
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0
PartA:SIR 50 mg SC q4w+6 Month Prednisone	1
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Week 24, n=23,21,16,17,16

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	2
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0
PartA:SIR 50 mg SC q4w+6 Month Prednisone	1
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Week 28, n=19,18,12,14,14

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	0
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0
PartA:SIR 50 mg SC q4w+6 Month Prednisone	1
PartA:Placebo SC q2w + 6 Month Prednisone	0
PartA:Placebo SC q2w + 12 Month Prednisone	0

Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time Secondary · Baseline (Week 0), Weeks 12, 24, 36, 52

SF-36v2 acute health survey questionnaire consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (b

PCS,Baseline, n=42,38,25,23,27

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	49.258	± 11.7655
PartA:SIR 100 mg SC q2w+3 Month Prednisone	43.271	± 12.3169
PartA:SIR 50 mg SC q4w+6 Month Prednisone	42.919	± 11.7298
PartA:Placebo SC q2w + 6 Month Prednisone	49.240	± 9.2759
PartA:Placebo SC q2w + 12 Month Prednisone	45.470	± 12.8498

PCS,Week 12, n=31,28,24,22,22

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	51.519	± 10.5352
PartA:SIR 100 mg SC q2w+3 Month Prednisone	43.128	± 11.4559
PartA:SIR 50 mg SC q4w+6 Month Prednisone	43.655	± 11.0324
PartA:Placebo SC q2w + 6 Month Prednisone	48.552	± 10.4184
PartA:Placebo SC q2w + 12 Month Prednisone	47.007	± 12.8749

PCS,Week 24, n=23,20,15,17,16

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	50.023	± 11.4731
PartA:SIR 100 mg SC q2w+3 Month Prednisone	45.677	± 12.1192
PartA:SIR 50 mg SC q4w+6 Month Prednisone	45.097	± 15.0552
PartA:Placebo SC q2w + 6 Month Prednisone	46.911	± 9.2901
PartA:Placebo SC q2w + 12 Month Prednisone	44.280	± 11.4740

PCS,Week 36, n=15,13,10,12,13

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	51.989	± 10.7521
PartA:SIR 100 mg SC q2w+3 Month Prednisone	47.069	± 12.7103
PartA:SIR 50 mg SC q4w+6 Month Prednisone	46.005	± 12.2496
PartA:Placebo SC q2w + 6 Month Prednisone	48.336	± 10.0154
PartA:Placebo SC q2w + 12 Month Prednisone	44.946	± 10.1921

PCS,Week 52, n=9,5,5,5,4

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	50.269	± 10.8743
PartA:SIR 100 mg SC q2w+3 Month Prednisone	53.690	± 7.9049
PartA:SIR 50 mg SC q4w+6 Month Prednisone	53.608	± 7.7721
PartA:Placebo SC q2w + 6 Month Prednisone	52.026	± 6.4892
PartA:Placebo SC q2w + 12 Month Prednisone	53.143	± 12.8351

MCS,Week 12, n=31,28,24,22,22

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	43.955	± 4.6164
PartA:SIR 100 mg SC q2w+3 Month Prednisone	45.264	± 5.7982
PartA:SIR 50 mg SC q4w+6 Month Prednisone	46.393	± 6.1792
PartA:Placebo SC q2w + 6 Month Prednisone	43.746	± 5.3179
PartA:Placebo SC q2w + 12 Month Prednisone	43.182	± 4.6707

MCS,Week 24, n=23,20,15,17,16

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	44.538	± 5.6952
PartA:SIR 100 mg SC q2w+3 Month Prednisone	45.954	± 5.4884
PartA:SIR 50 mg SC q4w+6 Month Prednisone	44.877	± 6.5210
PartA:Placebo SC q2w + 6 Month Prednisone	45.372	± 6.4561
PartA:Placebo SC q2w + 12 Month Prednisone	45.526	± 5.8924

MCS,Week 36, n=15,13,10,12,13

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	45.258	± 5.2429
PartA:SIR 100 mg SC q2w+3 Month Prednisone	45.540	± 4.8330
PartA:SIR 50 mg SC q4w+6 Month Prednisone	44.550	± 6.7199
PartA:Placebo SC q2w + 6 Month Prednisone	42.959	± 4.8484
PartA:Placebo SC q2w + 12 Month Prednisone	46.755	± 4.8284

Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time Secondary · Baseline (Week 0) and Weeks 12, 24, 36, 52

EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score wa

Baseline, n=42,38,25,23,27

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	0.7918	± 0.20589
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0.6681	± 0.31299
PartA:SIR 50 mg SC q4w+6 Month Prednisone	0.6912	± 0.19348
PartA:Placebo SC q2w + 6 Month Prednisone	0.7429	± 0.22387
PartA:Placebo SC q2w + 12 Month Prednisone	0.7554	± 0.16610

Week 12, n=31,28,24,22,22

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	0.7866	± 0.22042
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0.7024	± 0.22087
PartA:SIR 50 mg SC q4w+6 Month Prednisone	0.7452	± 0.17942
PartA:Placebo SC q2w + 6 Month Prednisone	0.7228	± 0.16993
PartA:Placebo SC q2w + 12 Month Prednisone	0.7069	± 0.22289

Week 24, n=23,20,15,17,16

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	0.7485	± 0.20310
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0.7217	± 0.21397
PartA:SIR 50 mg SC q4w+6 Month Prednisone	0.7135	± 0.24006
PartA:Placebo SC q2w + 6 Month Prednisone	0.7323	± 0.10346
PartA:Placebo SC q2w + 12 Month Prednisone	0.7301	± 0.11498

Week 36, n=15,13,10,12,13

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	0.8011	± 0.13468
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0.7454	± 0.22373
PartA:SIR 50 mg SC q4w+6 Month Prednisone	0.7774	± 0.11809
PartA:Placebo SC q2w + 6 Month Prednisone	0.6950	± 0.15242
PartA:Placebo SC q2w + 12 Month Prednisone	0.7506	± 0.17536

Week 52, n=9,5,5,5,4

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	0.8210	± 0.13502
PartA:SIR 100 mg SC q2w+3 Month Prednisone	0.7628	± 0.15352
PartA:SIR 50 mg SC q4w+6 Month Prednisone	0.8092	± 0.04275
PartA:Placebo SC q2w + 6 Month Prednisone	0.7864	± 0.05892
PartA:Placebo SC q2w + 12 Month Prednisone	0.8068	± 0.06050

Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time Secondary · Baseline (Week 0) and Weeks 12, 24, 36, 52

EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of the 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. The index score was derived from th

Baseline, n=42,38,25,23,27

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	67.0	± 17.83
PartA:SIR 100 mg SC q2w+3 Month Prednisone	65.6	± 21.43
PartA:SIR 50 mg SC q4w+6 Month Prednisone	57.0	± 17.61
PartA:Placebo SC q2w + 6 Month Prednisone	62.1	± 23.81
PartA:Placebo SC q2w + 12 Month Prednisone	65.1	± 16.00

Week 12, n=31,28,24,22,22

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	74.3	± 19.77
PartA:SIR 100 mg SC q2w+3 Month Prednisone	64.2	± 22.89
PartA:SIR 50 mg SC q4w+6 Month Prednisone	68.4	± 19.39
PartA:Placebo SC q2w + 6 Month Prednisone	63.3	± 22.61
PartA:Placebo SC q2w + 12 Month Prednisone	65.5	± 21.33

Week 24, n=23,20,15,17,16

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	74.6	± 16.26
PartA:SIR 100 mg SC q2w+3 Month Prednisone	70.6	± 24.05
PartA:SIR 50 mg SC q4w+6 Month Prednisone	65.1	± 23.11
PartA:Placebo SC q2w + 6 Month Prednisone	64.9	± 19.03
PartA:Placebo SC q2w + 12 Month Prednisone	61.5	± 19.71

Week 36, n=15,13,10,12,13

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	79.5	± 9.55
PartA:SIR 100 mg SC q2w+3 Month Prednisone	73.9	± 24.55
PartA:SIR 50 mg SC q4w+6 Month Prednisone	66.9	± 20.72
PartA:Placebo SC q2w + 6 Month Prednisone	68.3	± 18.66
PartA:Placebo SC q2w + 12 Month Prednisone	61.6	± 21.29

Week 52, n=9,5,5,5,4

Group	Value	95% CI
PartA:SIR 100 mg SC q2w+6 Month Prednisone	79.9	± 9.74
PartA:SIR 100 mg SC q2w+3 Month Prednisone	80.6	± 16.50
PartA:SIR 50 mg SC q4w+6 Month Prednisone	78.4	± 14.77
PartA:Placebo SC q2w + 6 Month Prednisone	60.2	± 26.33
PartA:Placebo SC q2w + 12 Month Prednisone	70.0	± 27.41

Adverse events — posted to ClinicalTrials.gov

Time frame: On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A:SIR 100 mg SC q2w+6 Month Prednisone

Serious: 8/42 (19%)

Deaths: 0/42

Part A:SIR 100 mg SC q2w+3 Month Prednisone

Serious: 6/39 (15%)

Deaths: 0/39

Part A: SIR 50 mg SC q4w+6 Month Prednisone

Serious: 6/26 (23%)

Deaths: 0/26

Part A:Placebo SC q2w + 6 Month Prednisone

Serious: 5/27 (19%)

Deaths: 0/27

Part A:Placebo SC q2w + 12 Month Prednisone

Serious: 6/27 (22%)

Deaths: 0/27

Part B:SIR 100 mg SC q2w+6 Month Prednisone+100mg OL SIR

Serious: 0/2 (0%)

Deaths: 0/2

Part B:SIR 100 mg SC q2w+3 Month Prednisone+100mg OL SIR

Serious: 0/1 (0%)

Deaths: 0/1

Part B:SIR 50 mg SC q4w+6 Month Prednisone+100mg OL SIR

Serious: 0/1 (0%)

Deaths: 0/1

Part B:Placebo SC q2w + 6 Month Prednisone+100mg OL SIR

Serious: 0/2 (0%)

Deaths: 0/2

Part B:Placebo SC q2w + 12 Month Prednisone+100mg OL SIR

Serious: 0/2 (0%)

Deaths: 0/2

Part B:SIR 100 mg SC q2w+6 Month Prednisone/ No 100mg OL SIR

Serious: 0/6 (0%)

Deaths: 0/6

Part B:SIR 100 mg SC q2w+3 Month Prednisone/ No 100mg OL SIR

Serious: 0/4 (0%)

Deaths: 0/4

Part B:SIR 50 mg SC q4w+6 Month Prednisone/ No 100mg OL SIR

Serious: 0/3 (0%)

Deaths: 0/3

Part B:Placebo SC q2w + 6 Month Prednisone/ No 100mg OL SIR

Serious: 0/3 (0%)

Deaths: 0/3

Part B:Placebo SC q2w + 12 Month Prednisone/ No 100mg OL SIR

Serious: 0/2 (0%)

Deaths: 0/2

Serious adverse events (37 terms)

Reaction	System	Part A:SIR 100 mg SC q2w+6…	Part A:SIR 100 mg SC q2w+3…	Part A: SIR 50 mg SC q4w+6…	Part A:Placebo SC q2w + 6 …	Part A:Placebo SC q2w + 12…	Part B:SIR 100 mg SC q2w+6…	Part B:SIR 100 mg SC q2w+3…	Part B:SIR 50 mg SC q4w+6 …	Part B:Placebo SC q2w + 6 …	Part B:Placebo SC q2w + 12…	Part B:SIR 100 mg SC q2w+6…	Part B:SIR 100 mg SC q2w+3…	Part B:SIR 50 mg SC q4w+6 …	Part B:Placebo SC q2w + 6 …	Part B:Placebo SC q2w + 12…
Syncope	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Clostridium difficile colitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Escherichia sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Metapneumovirus infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vestibular neuronitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Brain contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rib fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Spinal compression fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Subdural haematoma	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Transient ischaemic attack	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Synovial cyst	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tenosynovitis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chest discomfort	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Angina pectoris	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (99 terms — click to expand)

Reaction	System	Part A:SIR 100 mg SC q2w+6…	Part A:SIR 100 mg SC q2w+3…	Part A: SIR 50 mg SC q4w+6…	Part A:Placebo SC q2w + 6 …	Part A:Placebo SC q2w + 12…	Part B:SIR 100 mg SC q2w+6…	Part B:SIR 100 mg SC q2w+3…	Part B:SIR 50 mg SC q4w+6 …	Part B:Placebo SC q2w + 6 …	Part B:Placebo SC q2w + 12…	Part B:SIR 100 mg SC q2w+6…	Part B:SIR 100 mg SC q2w+3…	Part B:SIR 50 mg SC q4w+6 …	Part B:Placebo SC q2w + 6 …	Part B:Placebo SC q2w + 12…
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Injection site erythema	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Injection site reaction	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Injection site pruritus	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Injection site swelling	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Limb injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain in jaw	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tremor	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bursitis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Syncope, Clostridium difficile colitis, Escherichia sepsis, Metapneumovirus infection, Pneumonia, Urinary tract infection, Vestibular neuronitis, Brain contusion.

Data from ClinicalTrials.gov NCT02531633 adverse events section.

Sponsor's own description

Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high affinity and specificity for binding to the human IL-6 molecule that may have therapeutic benefit in the treatment of giant cell arteritis (GCA) by interruption of multiple pathogenic pathways. Sirukumab inhibits IL-6-mediated signal transducer and activator of transcription 3 (STAT3) phosphorylation, resulting in the inhibition of the biological effect of IL-6. This study will evaluate the efficacy and safety of sirukumab to characterize the benefit-to-risk profile of sirukumab in the treatment of active GCA. The study will be conducted in 2 distinct parts (Part A and Part B) and consists of the following phases: Screening phase, Part A: 52-week double-blind treatment phase, Part B: 104-week extension phase with the option to receive open-label sirukumab based on disease status and a 16-week follow-up phase if applicable. Approximately 204 subjects with a diagnosis of GCA and active disease within 6 weeks of baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week 52. Subjects completing Part A of the study will be eligible to enter Part B, the 104-week extension phase, designed to investigate the long-term maintenance of remission and safety following cessation of sirukumab treatment and to assess long-term corticosteroid use. Subjects with active GCA at the end of Part A or those with new onset of GCA flare during the first 52 weeks of Part B will be eligible to receive open-label sirukumab. Subjects will need to have follow-up safety evaluations for at least 16 weeks after receiving the last dose of study drug, applicable only for those who are withdrawn prematurely from the study or whose open-label sirukumab treatment in Part B completes after Week 88.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Antibodies to watch in 2018.
Kaplon H, Reichert JM. · · 2018 · cited 179× · PMID 29300693 · DOI 10.1080/19420862.2018.1415671
Targeting the Microglial Signaling Pathways: New Insights in the Modulation of Neuropathic Pain.
Popiolek-Barczyk K, Mika J. · · 2016 · cited 140× · PMID 27281131 · DOI 10.2174/0929867323666160607120124
A new era for giant cell arteritis.
Lyons HS, Quick V, Sinclair AJ, Nagaraju S, et al · · 2020 · cited 50× · PMID 31582795 · DOI 10.1038/s41433-019-0608-7
Giant cell arteritis: pathogenic mechanisms and new potential therapeutic targets.
Koster MJ, Warrington KJ. · · 2017 · cited 38× · PMID 30886946 · DOI 10.1186/s41927-017-0004-5
Development of a Core Set of Outcome Measures for Large-vessel Vasculitis: Report from OMERACT 2016.
Sreih AG, Alibaz-Oner F, Kermani TA, Aydin SZ, et al · · 2017 · cited 32× · PMID 28864646 · DOI 10.3899/jrheum.161467
A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Giant Cell Arteritis.
Schmidt WA, Dasgupta B, Luqmani R, Unizony SH, et al · · 2020 · cited 31× · PMID 32844378 · DOI 10.1007/s40744-020-00227-2
Advances in the Treatment of Giant Cell Arteritis.
Castañeda S, Prieto-Peña D, Vicente-Rabaneda EF, Triguero-Martínez A, et al · · 2022 · cited 27× · PMID 35329914 · DOI 10.3390/jcm11061588
Sirukumab: A Potential Treatment for Mood Disorders?
Zhou AJ, Lee Y, Salvadore G, Hsu B, et al · · 2017 · cited 21× · PMID 27913990 · DOI 10.1007/s12325-016-0455-x

Verify or expand the search:

Other trials of Sirukumab

Trials testing the same drug.

NCT04380961 — A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease ( · Phase 2 · completed
NCT02899026 — Efficacy and Safety Study of Sirukumab in Subjects With Polymyalgia Rheumatica · Phase 3 · withdrawn
NCT02794519 — A Phase 2a Study to Evaluate the Effects of Sirukumab in Subjects With Severe Poorly Controlled Asthma · Phase 2 · withdrawn
NCT01636557 — A Study to Evaluate the Effect of a Single Dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous A · Phase 1 · completed
NCT01604343 — A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disea · Phase 3 · completed

Other recruiting trials for Giant Cell Arteritis

Currently open trials in the same condition.

NCT07084480 — Giant Cell Arteritis - Ways to Precision Medicine · recruiting
NCT06894602 — Association of Ultrasonographic Temporal Artery Lesions and Relapse in Patients With Giant Cell Arteritis · recruiting
NCT05935709 — DANIsh VASculitis Database (DANIVAS) · recruiting
NCT06460142 — Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic · recruiting
NCT06011512 — Risk of Diabetes Mellitus in Patients With Giant Cell Arthritis and Polymyalgia Rheumatica. · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02531633 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 31 July 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02531633.

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NCT02531633

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (37 terms)

Sponsor's own description

Publications & conference data

Related trials

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Verify against primary sources