NCT02955147: UGCA

Ustekinumab for the Treatment of Giant Cell Arteritis

Terminated Phase 1, PHASE2 Results posted Last updated 12 June 2020

What this trial tests

Phase 1, PHASE2 trial testing Ustekinumab in Giant Cell Arteritis in 13 participants. Terminated before completion.

Timeline

1 December 2016

Primary endpoint
25 July 2019

19 September 2019

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	1 December 2016
Primary completion	25 July 2019
Estimated completion	19 September 2019
Sites	1 location across United States

Drugs / interventions tested

• Ustekinumab (ustekinumab) — full drug profile →
• Prednisone (prednisone) — full drug profile →

Conditions studied

• Giant Cell Arteritis — all drugs for Giant Cell Arteritis →
• Temporal Arteritis — all drugs for Temporal Arteritis →
• Horton's Disease — all drugs for Horton's Disease →

Sponsor

Massachusetts General Hospital

Who can join

50 and older, any sex, with Giant Cell Arteritis or Temporal 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.

Percentage of Patients in Glucocorticoid-free Remission Primary · 52 weeks

The primary study endpoint, prednisone-free remission, was defined as: 1) absence of relapse from the time that remission was achieved through week 52; 2) normalization of ESR (\<40 mm/hour) and CRP (\<10 mg/L); and, 3) adherence to the protocol prednisone taper.

Group	Value	95% CI
Ustekinumab Plus Prednisone	3

Number of Participants With Disease Flare Secondary · 52 weeks

Disease relapse was defined as the recurrence of signs or symptoms of GCA (e.g., cranial or PMR) that required treatment intensification, regardless of the ESR and CRP levels.

Group	Value	95% CI
Ustekinumab Plus Prednisone	7

Cumulative Prednisone Dose Secondary · 52 weeks

Group	Value	95% CI
Ustekinumab Plus Prednisone	2289	± 498

Number of Participants With at Least One Adverse Event Secondary · 52 weeks

Group	Value	95% CI
Ustekinumab Plus Prednisone	12

Adverse events — posted to ClinicalTrials.gov

Time frame: 60 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ustekinumab Plus Prednisone

Serious: 1/13 (8%)

Deaths: 0/13

Serious adverse events (1 terms)

Reaction	System	Ustekinumab Plus Prednisone
Diverticulitis	Gastrointestinal disorders	—

Other adverse events (4 terms — click to expand)

Reaction	System	Ustekinumab Plus Prednisone
Pneumonia	Respiratory, thoracic and mediastinal disorders	—
Bronchitis	Respiratory, thoracic and mediastinal disorders	—
Gastroenteritis	Gastrointestinal disorders	—
urinary tract infection	Renal and urinary disorders	—

Most-reported serious reactions: Diverticulitis.

Data from ClinicalTrials.gov NCT02955147 adverse events section.

Sponsor's own description

The purpose of this study is to determine whether ustekinumab is effective in the treatment of Giant Cell Arteritis (GCA)

Publications & conference data

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

1. Review: What Is the Current Evidence for Disease Subsets in Giant Cell Arteritis?
   van der Geest KSM, Sandovici M, van Sleen Y, Sanders JS, et al · · 2018 · cited 46× · PMID 29648680 · DOI 10.1002/art.40520
2. 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
3. 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
4. Adverse Events Associated With Anti-IL-23 Agents: Clinical Evidence and Possible Mechanisms.
   Ru Y, Ding X, Luo Y, Li H, et al · · 2021 · cited 21× · PMID 34177909 · DOI 10.3389/fimmu.2021.670398
5. Ustekinumab For the Treatment of Giant Cell Arteritis: Comment on the Article by Matza et al.
   Samson M, Bonnotte B. · · 2021 · cited 4× · PMID 32702165 · DOI 10.1002/acr.24376