Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)
Lead Sponsor:
Sanofi
Conditions:
Dermatitis Atopic
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe ato...
Eligibility Criteria
Inclusion
- Participants must be 12 years of age (when signing informed consent form)
- Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
- Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)
- v-IGA-AD of 3 or 4 at baseline visit
- EASI score of 16 or higher at baseline
- AD involvement of 10% or more of BSA at baseline
- Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
- Able and willing to comply with requested study visits and procedures
- Body weight ≥ 25 kg
Exclusion
- Participants are excluded from the study if any of the following criteria apply:
- Skin co-morbidity that would adversely affect the ability to undertake AD assessments
- Known history of or suspected significant current immunosuppression
- Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured \>5 years prior to baseline)
- History of solid organ or stem cell transplant
- Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline
- Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
- Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
- Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
- In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
- History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
December 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2026
Estimated Enrollment :
589 Patients enrolled
Trial Details
Trial ID
NCT06181435
Start Date
December 21 2023
End Date
March 18 2026
Last Update
December 10 2025
Active Locations (142)
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1
Center for Dermatology and Plastic Surgery- Site Number : 8401119
Scottsdale, Arizona, United States, 85260
2
Eclipse Clinical Research- Site Number : 8401158
Tucson, Arizona, United States, 85745
3
Torrance Clinical Research- Site Number : 8401027
Lomita, California, United States, 90717
4
Dermatology Research Associates - Los Angeles- Site Number : 8401092
Los Angeles, California, United States, 90045