At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Study to Assess Immunization Responses in Adult and Adolescent Subjects With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab
In Brief
A Phase 2 clinical trial evaluating Nemolizumab and Placebo for Dermatitis, Atopic. Completed, enrolled 242 participants across 64 sites.
Signals
Detailed Summary
The purpose of this study is to assess the effect of nemolizumab (CD14152) on humoral immune responses to tetanus and meningococcal vaccination in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD).
Study Details
Timeline
Arms & Interventions
Participants received a loading dose of nemolizumab (60 milligram \[mg\]) via 2 subcutaneous (SC) injections at baseline. Nemolizumab (30 mg) was administered via a single subcutaneous injection every 4 weeks (Q4W) at Weeks 4, 8, and 12.
Participants received a placebo via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12.
Interventions
Nemolizumab was administered by 2 SC injections as 60-mg loading dose at baseline and a single 30-mg dose at Weeks 4, 8, and 12.
Placebo was administered by 2 SC injections at baseline and a single dose at Weeks 4, 8, and 12.