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

Summary

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.

Timeline

Start

2021-12-13

Primary completion

2023-04-26

Completion

2024-02-21

Publications

• Reich A, Blauvelt A, Weidinger S, Shi VY, Katoh N, Lynde C, Gao X, Armstrong NM, Bernigaud C, Rahawi K. A Post Hoc Analysis of Atopic Dermatitis of the Head and Neck and Other Body Regions from the Amlitelimab STREAM-AD Phase 2b Study. Dermatol Ther (Heidelb). 2026 Jan;16(1):605-616. doi: 10.1007/s13555-025-01609-6. Epub 2025 Dec 8.
• Blauvelt A, Chovatiya R, Merola JF, Weidinger S, Igawa K, Brookes E, Weber C, Wang J, Gray C. Improvement and maintenance of clinical outcome assessments in atopic dermatitis with amlitelimab. J Eur Acad Dermatol Venereol. 2025 Dec;39(12):2113-2120. doi: 10.1111/jdv.20877. Epub 2025 Jul 24.
• Weidinger S, Blauvelt A, Papp KA, Reich A, Lee CH, Worm M, Lynde C, Kataoka Y, Foley P, Wei X, Wong W, Solente AC, Weber C, Adelman S, Davey S, Hurbin F, Rynkiewicz N, Yen K, O'Malley JT, Bernigaud C. Phase 2b randomized clinical trial of amlitelimab, an anti-OX40 ligand antibody, in patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2025 Apr;155(4):1264-1275. doi: 10.1016/j.jaci.2024.10.031. Epub 2024 Nov 8.

Drugs

Indications