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NCT05769777 · ClinicalTrials.gov registry record · Phase 2
Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
A Phase 2 study of Dermatitis, Atopic, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 901
- Enrollment target
- 20
- Study locations
NCT05769777: Recruiting Phase 2 study of Dermatitis, Atopic, sponsored by Sanofi.
NCT05769777 is a Phase 2 study of Dermatitis, Atopic that is actively recruiting participants, run by Sanofi. The registered enrollment target is 901 participants, above the 366-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (146% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05769777, a Phase 2 study of Dermatitis, Atopic, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 901 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 284 weeks, including: * A screening period of up to 2 to 4 weeks * An open label treatment period of up to 268 weeks (approximately 5 years) * A post-treatment safety follow-up period of at least 20 weeks after the last dose administration (last IMP administration at Week 264) The planned number of visits will be 35 visits.
Primary Outcome
Percentage of participants who experienced TEAEs from baseline during the study
Conditions Studied
Interventions
- DRUG Amlitelimab
Study Locations (20)
Florida
- Renaissance Research and Medical Group- Site Number : 8400006 - Cape Coral
- Florida Pharmaceutical Research and Associates- Site Number : 8400018 - Miami
- Miami Clinical Research Tower- Site Number : 8400036 - Miami
- Florida Research Center- Site Number : 8400011 - Miami
- Clinical Research Trials of Florida- Site Number : 8400054 - Tampa
Michigan
- The Derm Institute of West Michigan- Site Number : 8400043 - Caledonia
- Michigan Dermatology Institute - Livonia- Site Number : 8401010 - Livonia
- Michigan Dermatology Institute - Waterford- Site Number : 8400010 - Waterford
Colorado
- Children's Hospital Colorado - Aurora- Site Number : 8400041 - Aurora
- IMMUNOe International Research Centers - Centennial- Site Number : 8400024 - Centennial
Georgia
- Advanced Medical Research - Atlanta- Site Number : 8400044 - Atlanta
- Georgia Skin & Cancer Clinic- Site Number : 8400048 - Savannah
Alabama
- Allervie Clinical Research - Birmingham- Site Number : 8400050 - Birmingham
Arizona
- Research Solutions of Arizona- Site Number : 8400020 - Litchfield Park
Arkansas
- Dermatology Trial Associates- Site Number : 8400027 - Bryant
California
- University Dermatology Trials- Site Number : 8400052 - Newport Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 901 participants |
| Start Date | 2023-04-03 |
| Est. Completion | 2031-06-11 |
| Phase | Phase 2 |
What NCT05769777 shows while recruiting
NCT05769777 is an interventional study that assigns participants to a tested intervention. The registered 901 participants enrollment target is mid-sized for trials with a published cap, above the 366-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (146% higher).
The record links to 1 condition, with Dermatitis, Atopic appearing as the primary indexed condition, and to 1 intervention - of which Amlitelimab is the first listed.
NCT05769777 names 20 study sites across 12 states, led by Florida, Michigan, Colorado.
Frequently Asked Questions
What is clinical trial NCT05769777 about?
NCT05769777 is a clinical study titled "Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis". This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD...
What is the current status of trial NCT05769777?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 901 participants. The study started on 2023-04-03. Estimated completion is 2031-06-11.
What conditions does trial NCT05769777 study?
This clinical trial studies the following conditions: Dermatitis, Atopic.
What interventions are being tested in trial NCT05769777?
The interventions under investigation include: Amlitelimab (DRUG).
Who is sponsoring clinical trial NCT05769777?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05769777 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dermatitis, Atopic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05769777's enrollment target sits among peer trials
901 3rd of 29 higher than 27 of 29 other Dermatitis, Atopic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dermatitis, Atopic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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