NCT05131477 (STREAM-AD) is a Phase 2 clinical trial of Amlitelimab in Eczema, sponsored by Kymab Limited.

Who is sponsoring NCT05131477?

NCT05131477 is sponsored by Kymab Limited.

What drugs are being tested in NCT05131477?

Interventions in NCT05131477: Amlitelimab, Placebo.

What condition does NCT05131477 study?

NCT05131477 studies Eczema, Atopic Dermatitis.

Is NCT05131477 still recruiting?

NCT05131477 is currently completed. Last updated 3 July 2025.

Are results published for NCT05131477?

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

Last reviewed 2025-07-03 · How we verify

NCT05131477: STREAM-AD

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

Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study

Completed Phase 2 Results posted Last updated 3 July 2025

What this trial tests

Phase 2 trial testing Amlitelimab in Eczema in 390 participants. Completed in 21 February 2024.

Timeline

13 December 2021

Primary endpoint
26 April 2023

21 February 2024

Quick facts

Lead sponsor	Kymab Limited
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	390
Start date	13 December 2021
Primary completion	26 April 2023
Estimated completion	21 February 2024
Sites	103 locations across Japan, Taiwan, United Kingdom, Germany, Hungary, Poland, Canada, Bulgaria

Drugs / interventions tested

Amlitelimab — full drug profile →
Placebo

Conditions studied

Eczema — all drugs for Eczema →
Atopic Dermatitis — all drugs for Atopic Dermatitis →

Sponsor

Kymab Limited — full company profile →

Who can join

Adults 18 to 75, any sex, with Eczema or Atopic Dermatitis. 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 Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) Primary · Baseline to week 16

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	-61.5	± 4.68
250 mg (no LD) KY1005 (Part 1)	-56.8	± 4.59
125 mg KY1005 (Part 1)	-51.6	± 4.59
62.5 mg KY1005 (Part 1)	-59.6	± 4.53
Placebo (Part 1)	-29.4	± 4.76

Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) Secondary · Baseline to week 24

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	-64.4	± 5.17
250 mg (no LD) KY1005 (Part 1)	-52.2	± 5.14
125 mg KY1005 (Part 1)	-53.7	± 5.08
62.5 mg KY1005 (Part 1)	-54.4	± 5.09
Placebo (Part 1)	-27.6	± 5.29

Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) Secondary · Baseline to week 16 and week 24

Week 16

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	40.3
250 mg (no LD) KY1005 (Part 1)	38.5
125 mg KY1005 (Part 1)	42.9
62.5 mg KY1005 (Part 1)	40.5
Placebo (Part 1)	11.4

Week 24

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	54.5
250 mg (no LD) KY1005 (Part 1)	38.5
125 mg KY1005 (Part 1)	49.4
62.5 mg KY1005 (Part 1)	40.5
Placebo (Part 1)	17.7

Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) Secondary · Baseline to week 16 and week 24

The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear,1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD.

Week 16

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	22.1
250 mg (no LD) KY1005 (Part 1)	14.1
125 mg KY1005 (Part 1)	19.5
62.5 mg KY1005 (Part 1)	25.3
Placebo (Part 1)	5.1

Week 24

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	45.5
250 mg (no LD) KY1005 (Part 1)	33.3
125 mg KY1005 (Part 1)	40.3
62.5 mg KY1005 (Part 1)	29.1
Placebo (Part 1)	11.4

Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) Secondary · Baseline to week 16 and week 24

The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.

Week 16

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	24.7
250 mg (no LD) KY1005 (Part 1)	19.2
125 mg KY1005 (Part 1)	20.8
62.5 mg KY1005 (Part 1)	22.8
Placebo (Part 1)	5.1

Week 24

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	31.2
250 mg (no LD) KY1005 (Part 1)	24.4
125 mg KY1005 (Part 1)	28.6
62.5 mg KY1005 (Part 1)	27.8
Placebo (Part 1)	7.6

Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) Secondary · Baseline to weeks week 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52

The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.

Week 24

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	53.8
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	41.2
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	75.0
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	35.7
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	58.3
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	45.5
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	71.4
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	45.7
Placebo (Part 2) Continued From Part 1 Placebo	25.0

Week 25

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	53.8
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	41.2
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	66.7
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	39.3
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	66.7
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	39.4
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	57.1
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	37.1
Placebo (Part 2) Continued From Part 1 Placebo	31.3

Week 26

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	53.8
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	38.2
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	66.7
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	32.1
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	58.3
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	33.3
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	71.4
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	42.9
Placebo (Part 2) Continued From Part 1 Placebo	25.0

Week 27

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	61.5
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	35.3
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	58.3
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	28.6
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	58.3
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	39.4
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	71.4
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	37.1
Placebo (Part 2) Continued From Part 1 Placebo	25.0

Week 28

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	61.5
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	35.3
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	66.7
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	35.7
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	58.3
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	42.4
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	57.1
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	37.1
Placebo (Part 2) Continued From Part 1 Placebo	25.0

Week 29

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	69.2
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	38.2
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	50.0
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	25.0
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	58.3
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	45.5
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	57.1
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	40.0
Placebo (Part 2) Continued From Part 1 Placebo	25.0

Week 30

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	61.5
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	44.1
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	58.3
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	25.0
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	66.7
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	36.4
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	42.9
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	42.9
Placebo (Part 2) Continued From Part 1 Placebo	18.8

Week 31

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	61.5
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	41.2
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	58.3
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	25.0
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	66.7
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	36.4
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	42.9
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	40.0
Placebo (Part 2) Continued From Part 1 Placebo	18.8

Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) Secondary · Baseline to weeks 2, 4, 8, 12, 16, 20 and 24

Week 2

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	-8.49	± 10.777
250 mg (no LD) KY1005 (Part 1)	-5.27	± 8.485
125 mg KY1005 (Part 1)	-6.17	± 10.071
62.5 mg KY1005 (Part 1)	-7.51	± 8.836
Placebo (Part 1)	-3.98	± 7.855

Week 4

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	-11.21	± 10.612
250 mg (no LD) KY1005 (Part 1)	-8.38	± 9.944
125 mg KY1005 (Part 1)	-10.33	± 10.861
62.5 mg KY1005 (Part 1)	-10.27	± 10.550
Placebo (Part 1)	-7.20	± 8.510

Week 8

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	-15.67	± 11.872
250 mg (no LD) KY1005 (Part 1)	-11.93	± 11.018
125 mg KY1005 (Part 1)	-13.77	± 12.964
62.5 mg KY1005 (Part 1)	-14.37	± 10.054
Placebo (Part 1)	-7.64	± 10.450

Week 12

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	-18.49	± 12.411
250 mg (no LD) KY1005 (Part 1)	-13.84	± 11.121
125 mg KY1005 (Part 1)	-16.56	± 14.062
62.5 mg KY1005 (Part 1)	-16.46	± 11.699
Placebo (Part 1)	-8.76	± 9.608

Week 16

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	-19.71	± 12.731
250 mg (no LD) KY1005 (Part 1)	-16.31	± 12.329
125 mg KY1005 (Part 1)	-15.70	± 14.226
62.5 mg KY1005 (Part 1)	-17.82	± 11.730
Placebo (Part 1)	-7.47	± 11.338

Week 20

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	-21.93	± 14.283
250 mg (no LD) KY1005 (Part 1)	-16.46	± 12.834
125 mg KY1005 (Part 1)	-16.98	± 15.321
62.5 mg KY1005 (Part 1)	-16.76	± 12.590
Placebo (Part 1)	-7.91	± 11.163

Week 24

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	-21.92	± 14.475
250 mg (no LD) KY1005 (Part 1)	-15.72	± 12.977
125 mg KY1005 (Part 1)	-16.91	± 15.085
62.5 mg KY1005 (Part 1)	-17.09	± 13.088
Placebo (Part 1)	-7.52	± 12.537

Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) Secondary · Baseline to weeks 2,4, 8,12,16, 20 and 24

Week 2

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	-27.94	± 30.032
250 mg (no LD) KY1005 (Part 1)	-17.75	± 38.988
125 mg KY1005 (Part 1)	-19.09	± 39.499
62.5 mg KY1005 (Part 1)	-26.03	± 34.462
Placebo (Part 1)	-15.26	± 34.143

Week 4

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	-36.85	± 28.901
250 mg (no LD) KY1005 (Part 1)	-29.13	± 42.013
125 mg KY1005 (Part 1)	-35.10	± 34.457
62.5 mg KY1005 (Part 1)	-35.49	± 38.786
Placebo (Part 1)	-27.56	± 31.037

Week 8

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	-50.25	± 30.666
250 mg (no LD) KY1005 (Part 1)	-41.21	± 41.129
125 mg KY1005 (Part 1)	-45.96	± 38.150
62.5 mg KY1005 (Part 1)	-51.70	± 31.046
Placebo (Part 1)	-28.70	± 38.603

Week 12

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	-59.61	± 30.717
250 mg (no LD) KY1005 (Part 1)	-50.15	± 36.086
125 mg KY1005 (Part 1)	-55.23	± 40.218
62.5 mg KY1005 (Part 1)	-57.36	± 34.275
Placebo (Part 1)	-33.72	± 35.358

Week 16

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	-62.35	± 32.322
250 mg (no LD) KY1005 (Part 1)	-59.98	± 37.444
125 mg KY1005 (Part 1)	-52.50	± 40.820
62.5 mg KY1005 (Part 1)	-61.51	± 31.663
Placebo (Part 1)	-28.25	± 41.173

Week 20

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	-67.85	± 33.135
250 mg (no LD) KY1005 (Part 1)	-57.80	± 38.921
125 mg KY1005 (Part 1)	-56.29	± 43.103
62.5 mg KY1005 (Part 1)	-57.87	± 38.977
Placebo (Part 1)	-30.32	± 40.486

Week 24

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	-68.01	± 36.052
250 mg (no LD) KY1005 (Part 1)	-55.84	± 40.299
125 mg KY1005 (Part 1)	-56.72	± 44.271
62.5 mg KY1005 (Part 1)	-57.37	± 40.225
Placebo (Part 1)	-28.55	± 44.004

Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Secondary · Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52

Week 24

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	-29.65	± 11.278
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	-26.28	± 13.353
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	-27.60	± 11.170
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	-18.90	± 11.932
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	-27.10	± 12.670
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	-22.45	± 14.998
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	-25.47	± 12.209
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	-22.41	± 12.841
Placebo (Part 2) Continued From Part 1 Placebo	-21.47	± 10.420

Week 28

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	-30.51	± 12.422
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	-26.34	± 14.353
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	-25.86	± 13.128
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	-17.29	± 12.458
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	-26.37	± 13.067
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	-22.87	± 15.667
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	-23.79	± 10.424
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	-21.75	± 13.106
Placebo (Part 2) Continued From Part 1 Placebo	-21.69	± 11.918

Week 32

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	-29.08	± 14.544
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	-24.79	± 15.775
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	-22.99	± 15.741
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	-15.38	± 12.620
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	-27.36	± 13.383
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	-22.94	± 14.915
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	-24.94	± 11.245
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	-20.32	± 14.189
Placebo (Part 2) Continued From Part 1 Placebo	-19.60	± 10.632

Week 36

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	-28.15	± 15.138
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	-22.78	± 17.505
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	-22.27	± 16.368
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	-14.57	± 13.550
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	-27.51	± 13.550
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	-22.99	± 14.978
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	-24.65	± 10.801
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	-20.09	± 15.098
Placebo (Part 2) Continued From Part 1 Placebo	-20.20	± 10.436

Week 40

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	-28.54	± 15.203
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	-22.30	± 17.908
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	-22.56	± 14.949
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	-14.81	± 13.178
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	-27.96	± 14.444
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	-20.45	± 16.659
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	-25.51	± 11.796
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	-20.80	± 14.601
Placebo (Part 2) Continued From Part 1 Placebo	-20.05	± 10.596

Week 44

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	-28.43	± 15.061
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	-22.23	± 17.487
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	-23.07	± 15.679
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	-14.49	± 12.877
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	-27.49	± 14.324
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	-19.76	± 16.561
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	-22.34	± 11.070
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	-20.70	± 14.343
Placebo (Part 2) Continued From Part 1 Placebo	-20.43	± 11.007

Week 48

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	-22.15	± 14.876
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	-21.82	± 17.764
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	-22.24	± 16.312
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	-13.95	± 13.596
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	-27.72	± 14.882
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	-18.34	± 16.959
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	-23.88	± 12.517
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	-19.74	± 15.277
Placebo (Part 2) Continued From Part 1 Placebo	-19.99	± 11.292

Week 52

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	-22.03	± 14.889
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	-19.59	± 15.321
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	-22.68	± 15.418
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	-13.89	± 13.427
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	-28.08	± 16.097
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	-17.30	± 16.752
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	-23.26	± 11.789
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	-20.81	± 14.813
Placebo (Part 2) Continued From Part 1 Placebo	-20.30	± 11.526

Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) Secondary · Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52

Week 24

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	-91.71	± 8.539
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	-81.85	± 31.624
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	-84.20	± 16.741
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	-72.72	± 41.299
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	-90.91	± 10.585
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	-74.56	± 39.811
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	-85.81	± 10.212
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	-76.74	± 30.922
Placebo (Part 2) Continued From Part 1 Placebo	-78.51	± 28.977

Week 28

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	-93.56	± 8.382
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	-81.47	± 32.251
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	-79.34	± 28.091
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	-66.53	± 43.437
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	-87.78	± 13.648
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	-74.18	± 42.104
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	-89.88	± 6.304
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	-74.54	± 31.665
Placebo (Part 2) Continued From Part 1 Placebo	-76.87	± 31.377

Week 32

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	-86.08	± 24.896
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	-76.51	± 38.401
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	-69.06	± 38.468
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	-58.78	± 44.767
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	-91.07	± 13.744
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	-75.64	± 41.038
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	-93.76	± 4.960
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	-68.09	± 34.850
Placebo (Part 2) Continued From Part 1 Placebo	-71.98	± 33.063

Week 36

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	-86.56	± 28.656
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	-69.33	± 43.838
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	-66.64	± 39.631
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	-56.24	± 46.469
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	-91.22	± 13.203
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	-75.77	± 40.984
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	-93.09	± 6.000
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	-67.27	± 40.162
Placebo (Part 2) Continued From Part 1 Placebo	-74.93	± 32.664

Week 40

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	-84.74	± 28.948
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	-65.65	± 44.932
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	-68.31	± 38.024
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	-57.39	± 47.379
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	-90.68	± 13.737
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	-64.68	± 64.041
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	-95.55	± 5.011
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	-70.11	± 37.802
Placebo (Part 2) Continued From Part 1 Placebo	-74.05	± 32.343

Week 44

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	-84.46	± 28.757
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	-66.73	± 44.328
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	-69.41	± 38.731
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	-56.30	± 46.700
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	-90.18	± 12.912
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	-62.46	± 63.983
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	-83.57	± 21.909
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	-69.98	± 37.145
Placebo (Part 2) Continued From Part 1 Placebo	-72.99	± 33.353

Week 48

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	-71.66	± 40.416
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	-65.18	± 44.327
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	-66.61	± 39.645
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	-53.59	± 48.780
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	-90.26	± 12.961
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	-57.47	± 65.142
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	-88.02	± 22.234
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	-66.63	± 40.889
Placebo (Part 2) Continued From Part 1 Placebo	-70.92	± 33.888

Week 52

Group	Value	95% CI
250 mg KY1005 Re-Randomized From the LD Arm (Part 2)	-71.22	± 40.152
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	-61.78	± 44.406
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)	-68.09	± 37.719
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)	-53.58	± 48.725
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	-89.09	± 15.625
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	-54.42	± 65.177
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	-86.51	± 22.331
Placebo Re-randomized From the 62.5 mg Arm (Part 2)	-69.76	± 38.241
Placebo (Part 2) Continued From Part 1 Placebo	-72.04	± 34.827

Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) Secondary · Baseline to weeks 2, 4, 8, 12, 16, 20 and 24

Week 2

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	19.5
250 mg (no LD) KY1005 (Part 1)	15.4
125 mg KY1005 (Part 1)	16.9
62.5 mg KY1005 (Part 1)	22.8
Placebo (Part 1)	13.9

Week 4

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	29.9
250 mg (no LD) KY1005 (Part 1)	21.8
125 mg KY1005 (Part 1)	39.0
62.5 mg KY1005 (Part 1)	39.2
Placebo (Part 1)	24.1

Week 8

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	45.5
250 mg (no LD) KY1005 (Part 1)	38.5
125 mg KY1005 (Part 1)	53.2
62.5 mg KY1005 (Part 1)	54.4
Placebo (Part 1)	27.8

Week 12

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	62.3
250 mg (no LD) KY1005 (Part 1)	44.9
125 mg KY1005 (Part 1)	61.0
62.5 mg KY1005 (Part 1)	62.0
Placebo (Part 1)	26.6

Week 16

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	63.6
250 mg (no LD) KY1005 (Part 1)	52.6
125 mg KY1005 (Part 1)	57.1
62.5 mg KY1005 (Part 1)	65.8
Placebo (Part 1)	27.8

Week 20

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	63.6
250 mg (no LD) KY1005 (Part 1)	51.3
125 mg KY1005 (Part 1)	58.4
62.5 mg KY1005 (Part 1)	58.2
Placebo (Part 1)	25.3

Week 24

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	66.2
250 mg (no LD) KY1005 (Part 1)	43.6
125 mg KY1005 (Part 1)	55.8
62.5 mg KY1005 (Part 1)	53.2
Placebo (Part 1)	24.1

Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) Secondary · Baseline at weeks 2, 4, 8, 12, 16, 20 and 24

Week 2

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	9.1
250 mg (no LD) KY1005 (Part 1)	2.6
125 mg KY1005 (Part 1)	2.6
62.5 mg KY1005 (Part 1)	2.5
Placebo (Part 1)	5.1

Week 4

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	9.1
250 mg (no LD) KY1005 (Part 1)	9.0
125 mg KY1005 (Part 1)	11.7
62.5 mg KY1005 (Part 1)	11.4
Placebo (Part 1)	6.3

Week 8

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	23.4
250 mg (no LD) KY1005 (Part 1)	16.7
125 mg KY1005 (Part 1)	27.3
62.5 mg KY1005 (Part 1)	25.3
Placebo (Part 1)	8.9

Week 12

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	33.8
250 mg (no LD) KY1005 (Part 1)	25.6
125 mg KY1005 (Part 1)	44.2
62.5 mg KY1005 (Part 1)	43.0
Placebo (Part 1)	11.4

Week 16

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	40.3
250 mg (no LD) KY1005 (Part 1)	38.5
125 mg KY1005 (Part 1)	42.9
62.5 mg KY1005 (Part 1)	40.5
Placebo (Part 1)	11.4

Week 20

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	49.4
250 mg (no LD) KY1005 (Part 1)	42.3
125 mg KY1005 (Part 1)	48.1
62.5 mg KY1005 (Part 1)	40.5
Placebo (Part 1)	13.9

Week 24

Group	Value	95% CI
250 mg (500 mg LD) KY1005 (Part 1)	54.5
250 mg (no LD) KY1005 (Part 1)	38.5
125 mg KY1005 (Part 1)	49.4
62.5 mg KY1005 (Part 1)	40.5
Placebo (Part 1)	17.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

250 mg (500 mg LD) KY1005 (Part 1)

Serious: 2/77 (3%)

Deaths: 0/77

250 mg (no LD) KY1005 (Part 1)

Serious: 0/78 (0%)

Deaths: 0/78

125 mg KY1005 (Part 1)

Serious: 1/77 (1%)

Deaths: 0/77

62.5 mg KY1005 (Part 1)

Serious: 5/78 (6%)

Deaths: 0/78

Placebo (Part 1)

Serious: 1/78 (1%)

Deaths: 0/78

250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)

Serious: 1/13 (8%)

Deaths: 0/13

Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)

Serious: 1/34 (3%)

Deaths: 0/34

250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)

Serious: 0/11 (0%)

Deaths: 0/11

Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)

Serious: 2/28 (7%)

Deaths: 0/28

125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)

Serious: 1/12 (8%)

Deaths: 0/12

Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)

Serious: 0/32 (0%)

Deaths: 0/32

62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)

Serious: 0/7 (0%)

Deaths: 0/7

Placebo Re-randomized From the 62.5 mg Arm (Part 2)

Serious: 0/34 (0%)

Deaths: 0/34

Placebo (Part 2)

Serious: 0/15 (0%)

Deaths: 0/15

Serious adverse events (17 terms)

Reaction	System	250 mg (500 mg LD) KY1005 …	250 mg (no LD) KY1005 (Par…	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)	250 mg KY1005 Re-Randomize…	Placebo Re-Randomized From…	250 mg KY1005 Re-randomize…	Placebo Re-Randomized From…	125 mg KY1005 Re-randomize…	Placebo Re-randomized From…	62.5 mg Re-Randomized From…	Placebo Re-randomized From…	Placebo (Part 2)
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Supraventricular tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Haemorrhoidal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Umbilical hernia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ankle fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Forearm fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tendon rupture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abnormal loss of weight	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Metabolic acidosis	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tension Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alcohol withdrawal syndrome	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dermatitis bullous	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (51 terms — click to expand)

Reaction	System	250 mg (500 mg LD) KY1005 …	250 mg (no LD) KY1005 (Par…	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)	250 mg KY1005 Re-Randomize…	Placebo Re-Randomized From…	250 mg KY1005 Re-randomize…	Placebo Re-Randomized From…	125 mg KY1005 Re-randomize…	Placebo Re-randomized From…	62.5 mg Re-Randomized From…	Placebo Re-randomized From…	Placebo (Part 2)
DERMATITIS ATOPIC	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
NASOPHARYNGITIS	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
HEADACHE	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
DERMATITIS INFECTED	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
BLOOD CREATINE PHOSPHOKINASE INCREASED	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
HYPERTENSION	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
FATIGUE	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
ACCIDENTAL OVERDOSE	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
INFLUENZA	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
ORAL HERPES	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
PHARYNGITIS	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
POSTOPERATIVE WOUND INFECTION	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
RHINITIS	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
SINUSITIS	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
ALANINE AMINOTRANSFERASE INCREASED	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
HYPERCHOLESTEROLAEMIA	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
BACK PAIN	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
SPINAL PAIN	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
DIZZINESS	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
DYSMENORRHOEA	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
ABDOMINAL PAIN	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
FOOD POISONING	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
INFLUENZA LIKE ILLNESS	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
SEASONAL ALLERGY	Immune system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
BRONCHITIS VIRAL	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
CYSTITIS	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
FOLLICULITIS	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
FUNGAL SKIN INFECTION	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
HERPES SIMPLEX	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
OTITIS Media	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
PYURIA	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
TONSILLITIS	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
URINARY TRACT INFECTION	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
MUSCLE STRAIN	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Atrial fibrillation, Supraventricular tachycardia, Haemorrhoidal haemorrhage, Umbilical hernia, Appendicitis, Pharyngitis, Ankle fracture, Forearm fracture.

Data from ClinicalTrials.gov NCT05131477 adverse events section.

Sponsor's own description

This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 5-arm study to assess the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis. The estimated duration is 28 days for screening and then up to approximately day 477 (last dose no later than day 337+140 days safety follow-up) for all patients unless enrolled into the Long-Term Extension (LTE) protocol (NCT05492578) at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.

Publications & conference data

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

The translational revolution in atopic dermatitis: the paradigm shift from pathogenesis to treatment.
Facheris P, Jeffery J, Del Duca E, Guttman-Yassky E. · · 2023 · cited 150× · PMID 36928371 · DOI 10.1038/s41423-023-00992-4
OX40-OX40L Inhibition for the Treatment of Atopic Dermatitis-Focus on Rocatinlimab and Amlitelimab.
Lé AM, Torres T. · · 2022 · cited 60× · PMID 36559247 · DOI 10.3390/pharmaceutics14122753
OX40 in the Pathogenesis of Atopic Dermatitis-A New Therapeutic Target.
Croft M, Esfandiari E, Chong C, Hsu H, et al · · 2024 · cited 58× · PMID 38236520 · DOI 10.1007/s40257-023-00838-9
Phase 2b randomized clinical trial of amlitelimab, an anti-OX40 ligand antibody, in patients with moderate-to-severe atopic dermatitis.
Weidinger S, Blauvelt A, Papp KA, Reich A, et al · · 2025 · cited 28× · PMID 39522654 · DOI 10.1016/j.jaci.2024.10.031
Targeting TNF/TNFR superfamilies in immune-mediated inflammatory diseases.
Veerasubramanian PK, Wynn TA, Quan J, Karlsson FJ. · · 2024 · cited 26× · PMID 39297883 · DOI 10.1084/jem.20240806
Targeting alarmins in asthma: From bench to clinic.
Akenroye A, Boyce JA, Kita H. · · 2025 · cited 24× · PMID 39855362 · DOI 10.1016/j.jaci.2025.01.017
Emerging Biologic Therapies for the Treatment of Atopic Dermatitis.
Alvarenga JM, Bieber T, Torres T. · · 2024 · cited 20× · PMID 39365406 · DOI 10.1007/s40265-024-02095-4
An OX-Tra'Ordinary Tale: The Role of OX40 and OX40L in Atopic Dermatitis.
Sadrolashrafi K, Guo L, Kikuchi R, Hao A, et al · · 2024 · cited 19× · PMID 38607026 · DOI 10.3390/cells13070587

Verify or expand the search:

Other trials of Amlitelimab

Trials testing the same drug.

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NCT06557772 — A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease · Phase 2 · active not recruiting
NCT06444451 — A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Parti · Phase 2 · active not recruiting
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NCT06241118 — A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in · Phase 3 · recruiting

Other recruiting trials for Eczema

Currently open trials in the same condition.

NCT07463079 — Clinical Evaluation of a Soothing Moisturizing Lotion in Individuals With Atopic Eczema · NA · recruiting
NCT06807268 — A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema · Phase 3 · recruiting
NCT07355075 — A Study to Assess the Efficacy of GX-03 in Moderate to Severe Eczema (Atopic Dermatitis) · Phase 2 · recruiting
NCT06998446 — Sodium in the Skin and Atopic Dermatitis · recruiting
NCT06994520 — Efficacy of Topical Cannabidiol for Eczema · Phase 2 · active not recruiting

Other Kymab Limited trials

Trials by the same sponsor.

NCT04449939 — A Study of Subcutaneous KY1005 in Healthy Volunteers · Phase 1 · completed
NCT03829501 — A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Co · Phase 1, PHASE2 · terminated
NCT03754309 — A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis · Phase 2 · completed
NCT03161288 — A Study of KY1005 in Healthy Volunteers · Phase 1 · completed

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 NCT05131477 (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 Kymab Limited
Last refreshed: 3 July 2025

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/NCT05131477.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT05131477: STREAM-AD

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 (17 terms)

Sponsor's own description

Publications & conference data

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Verify against primary sources