A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
Secondary endpoints: details revised at 26 of 41 entries
MinorEnrollment closed, study ongoing
Enrollment reduced: 636 → 464 participants
Site details revised at 150 of 150 sites
v29
MinorStudy sites: 149 to 150v28
MinorStudy sites: 147 to 149v27
NotablePrimary completion pushed from May 25, 2026 to Sep 30, 2027
Enrollment increased: 390 → 636 participants
Study completion pushed from Sep 14, 2026 to Sep 29, 2028
Study sites: 146 to 147
v26
Show 24 earlier versionsHide 24 earlier versions
MinorStudy sites revised (146)v25
MinorSite details revised at 1 of 146 sitesv24
MinorStudy sites: 147 to 146v23
MinorStudy sites: 148 to 147v22
MinorStudy sites: 149 to 148v21
MinorEnrollment target: 330 to 390
Site details revised at 1 of 149 sites
v20
MinorStudy sites revised (149)v19
MinorStudy sites: 146 to 149v18
MinorEnrollment target: 249 to 330v17Show 4 more changesShow less
Study sites: 144 to 146
Primary completion date: Mar 10, 2026 to May 25, 2026
Study completion date: Jun 30, 2026 to Sep 14, 2026
Secondary endpoints revised (41)
NotablePrimary endpoints: 4 to 3
Study sites: 141 to 144
Secondary endpoints revised (41)
v16
MinorStudy sites: 138 to 141v15
MinorStudy sites: 140 to 138v14
MinorStudy sites: 134 to 140v13
MinorStudy sites: 124 to 134v12
MinorStudy sites: 119 to 124v11
MinorStudy sites: 112 to 119v10
MinorStudy sites: 105 to 112v9
MinorStudy sites: 103 to 105v8
NotablePrimary endpoints: 3 to 4
Study sites: 89 to 103
Primary completion date: Mar 20, 2026 to Mar 10, 2026
Secondary endpoints: 38 to 41
v7
MinorStudy sites: 73 to 89v6
MinorStudy sites: 53 to 73v5
MinorStudy sites: 27 to 53v4
MinorStudy sites: 9 to 27
Secondary endpoints revised (38)
v3
NotableTrial status: Not Yet Recruiting to Recruitingv2Show 5 more changesShow less
Study sites: 0 to 9
Start date changed from estimate of Jan 29, 2024 to Feb 29, 2024
Secondary endpoints: 32 to 38
Eligibility criteria expanded, about 3 words
Study title expanded, about 5 words
MinorStudy First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy.
The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy.
Study details include:
At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD).
The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up.
The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening and a 36-week randomized double-blind period.
The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 \[RIVER-AD\] study).