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NCT06015308 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo
A Phase 2 study of Dermatitis, Atopic, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 224
- Enrollment target
- 20
- Study locations
NCT06015308 is a Phase 2 study of Dermatitis, Atopic that has completed, run by Sanofi. The registered enrollment target is 224 participants, below the 389-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 5 states.
The verdict
NCT06015308, a Phase 2 study of Dermatitis, Atopic, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 224 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2, multicenter, randomized, double-blind placebo controlled, 2-arm study to evaluate the effect of amlitelimab on vaccine antibody responses, and the safety of amlitelimab concurrently administered with non-live vaccines in adult participants with moderate-to-severe atopic dermatitis (AD). The purpose of this study is to compare the immune responses to concomitantly administered Boostrix (tetanus, diphtheria, and acellular pertussis \[Tdap\]) and Pneumovax 23 (PPSV) vaccines in adult participants with moderate-to-severe AD treated with amlitelimab versus placebo. The study will evaluate the percentage of participants achieving a positive anti-tetanus response at Week 16 (primary endpoint) and a positive anti-pneumococcal response at Week 16 (key secondary endpoint). Study details include: The study duration will be up to 36 weeks (for participants not entering the LTS17367 \[RIVER-AD\]). The screening period will be 9 days to 4 weeks. The treatment duration will be up to 16 weeks. The post-treatment safety follow-up period will be16 weeks. The number of visits will be up to 7 (or 6 for those entering LTS17367 \[RIVER-AD\]).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Amlitelimab
- BIOLOGICAL Tdap vaccine
- BIOLOGICAL PPS vaccine
Study Locations (20)
California
- Orange County Clinical Trials- Site Number : 8401271 - Anaheim
- First OC Dermatology- Site Number : 8401025 - Fountain Valley
- Center for Dermatology Clinical Research- Site Number : 8401018 - Fremont
- Valley Research- Site Number : 8401097 - Fresno
- Paradigm Clinical Research Centers- Site Number : 8401273 - La Mesa
- Sunwise Clinical Research- Site Number : 8401022 - Lafayette
- Antelope Valley Clinical Trials- Site Number : 8401099 - Lancaster
- Torrance Clinical Research- Site Number : 8401027 - Lomita
- Clinical Science Institute- Site Number : 8401028 - Santa Monica
Florida
- Daxia Trials- Site Number : 8401145 - Boca Raton
- Encore Medical Research of Boynton Beach- Site Number : 8401030 - Boynton Beach
- Alliance for Multispeciality Research - Fort Myers- Site Number : 8401111 - Fort Myers
- Doral Medical Research- Site Number : 8401094 - Hialeah
- C&R Research Services - Kendall- Site Number : 8401029 - Kendall
- Acevedo Clinical Research Associates- Site Number : 8401088 - Miami
- Future Care Solution - Miami- Site Number : 8401144 - Miami
- Sanchez Clinical Research- Site Number : 8401095 - Miami
Alabama
- Clinical Research Center of Alabama - Homewood- Site Number : 8401101 - Birmingham
Arizona
- Center for Dermatology and Plastic Surgery- Site Number : 8401119 - Scottsdale
Colorado
- Velocity Clinical Research - Denver Site Number : 8401168 - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2023-10-06 |
| Est. Completion | 2026-01-16 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06015308
The ClinicalTrials.gov registry entry for NCT06015308 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 389-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (42% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Dermatitis, Atopic appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT06015308 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT06015308 about?
NCT06015308 is a clinical study titled "A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo". This is a Phase 2, multicenter, randomized, double-blind placebo controlled, 2-arm study to evaluate the effect of amlitelimab on vaccine antibody responses, and the safety of amlitelimab concurrently administered with non-live vaccines in adult participants with moderate-to-severe atopic dermatitis...
What is the current status of trial NCT06015308?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 224 participants. The study started on 2023-10-06. Estimated completion is 2026-01-16.
What conditions does trial NCT06015308 study?
This clinical trial studies the following conditions: Dermatitis, Atopic.
What interventions are being tested in trial NCT06015308?
The interventions under investigation include: Placebo (DRUG), Amlitelimab (DRUG), Tdap vaccine (BIOLOGICAL), PPS vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT06015308?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06015308 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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