Status:
COMPLETED
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
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
- 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 (1 week in the event of superficial skin infections)
- 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 potential participation in a clinical trial
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2025
Estimated Enrollment :
601 Patients enrolled
Trial Details
Trial ID
NCT06130566
Start Date
November 8 2023
End Date
November 13 2025
Last Update
November 24 2025
Active Locations (148)
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1
Scottsdale Clinical Trials- Site Number : 8401149
Scottsdale, Arizona, United States, 85260
2
First OC Dermatology- Site Number : 8401025
Fountain Valley, California, United States, 92708
3
Center for Dermatology Clinical Research- Site Number : 8401018
Fremont, California, United States, 94538
4
Sunwise Clinical Research- Site Number : 8401022
Lafayette, California, United States, 94549