Status:
TERMINATED
Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Lead Sponsor:
Sanofi
Conditions:
Hidradenitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a parallel, Phase 2, 2-arm, double-blind, randomized, multicenter, multinational, placebo-controlled study to evaluate efficacy, safety, pharmacokinetics (PK), and biological effects of treatm...
Detailed Description
The study duration per participant will be up to 116 weeks.
Eligibility Criteria
Inclusion
- Participant must be 18 (or country's age of majority if \>18) years to 70 years of age inclusive, at the time of signing the informed consent.
- Participants with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.
- Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), 1 of which must be Hurley Stage II or Hurley Stage III.
- Participant must have had an inadequate response to at least a 12-week trial of an oral antibiotic for treatment of HS
Exclusion
- Participants with a diagnosis of inflammatory conditions other than HS (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, multiple sclerosis, Behcet's disease, sarcoidosis, etc)
- Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS
- 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 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06118099
Start Date
November 1 2023
End Date
October 10 2025
Last Update
November 6 2025
Active Locations (42)
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1
Medical Dermatology Specialists Site Number : 8400002
Phoenix, Arizona, United States, 85006-2754
2
Center for Dermatology Clinical Research Site Number : 8400010
Fremont, California, United States, 94538-1614
3
Corazon USA, LLC (DBA Life Clinical Trials) Site Number : 8400011
Margate, Florida, United States, 33063
4
Florida International Research Center Site Number : 8400016
Miami, Florida, United States, 33173