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

Study acronym: AQUA
StatusActive, Not Recruiting
PhasePhase 3
SponsorSanofi
Started

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Trial flagged as At Risk
Enrollment reduced 27% 636 → 464 participants
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Record History

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  1. Minor Trial sites expanded: 150 → 154 locations
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 26 of 41 entries
  2. Minor Enrollment closed, study ongoing
    • Enrollment reduced: 636 → 464 participants
    • Site details revised at 150 of 150 sites
    v29
  3. Minor Study sites: 149 to 150v28
  4. Minor Study sites: 147 to 149v27
  5. Notable Primary 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
  1. Minor Study sites revised (146)v25
  2. Minor Site details revised at 1 of 146 sitesv24
  3. Minor Study sites: 147 to 146v23
  4. Minor Study sites: 148 to 147v22
  5. Minor Study sites: 149 to 148v21
  6. Minor Enrollment target: 330 to 390
    • Site details revised at 1 of 149 sites
    v20
  7. Minor Study sites revised (149)v19
  8. Minor Study sites: 146 to 149v18
  9. Minor Enrollment target: 249 to 330v17 Show 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)
  10. Notable Primary endpoints: 4 to 3
    • Study sites: 141 to 144
    • Secondary endpoints revised (41)
    v16
  11. Minor Study sites: 138 to 141v15
  12. Minor Study sites: 140 to 138v14
  13. Minor Study sites: 134 to 140v13
  14. Minor Study sites: 124 to 134v12
  15. Minor Study sites: 119 to 124v11
  16. Minor Study sites: 112 to 119v10
  17. Minor Study sites: 105 to 112v9
  18. Minor Study sites: 103 to 105v8
  19. Notable Primary 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
  20. Minor Study sites: 73 to 89v6
  21. Minor Study sites: 53 to 73v5
  22. Minor Study sites: 27 to 53v4
  23. Minor Study sites: 9 to 27
    • Secondary endpoints revised (38)
    v3
  24. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 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
  1. Minor Study 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.
285 trials monitored
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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).
Trial Details
NCT Number NCT06241118
Lead Sponsor Sanofi
Conditions
(from sponsor)
Dermatitis Atopic
Related terms Dermatitis, Atopic
Enrollment 464 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov