At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Amlitelimab and Placebo for Eczema and Atopic Dermatitis. Completed, enrolled 390 participants across 103 sites in 12 countries.
Detailed 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.
Study Details
Timeline
Interventions
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Pharmaceutical form: Injection solution Route of administration: Subcutaneous