NCT05131477

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

A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate-to-Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Kymab Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Eczema
• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Amlitelimab	Pharmaceutical form: Injection solution Route of administration: Subcutaneous
DRUG	Placebo	Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Timeline

• Start date: 2021-12-13
• Primary completion: 2023-04-26
• Completion: 2024-02-21
• First posted: 2021-11-23
• Last updated: 2025-07-03
• Results posted: 2025-07-03

Locations

103 sites across 12 countries: United States, Australia, Bulgaria, Canada, Czechia, Germany, Hungary, Japan, Poland, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study