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A Study to Investigate Efficacy and Safety of Duvakitug in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Sponsor: Sanofi
Summary
This is a parallel, Phase 2b, 3-arm, double-blind, randomized, multicenter, multinational, placebo-controlled, dose-ranging study to evaluate the efficacy and the safety of different doses of duvakitug in adult participants with moderate to severe hidradenitis suppurativa. Study details include: * The study duration will be up to 145 weeks , including a 4-week screening period, a 16-week initial double-blind treatment period, a 24-week active blinded extension period, a 96-week long-term extension period and a 5-week follow-up period. * The treatment duration will be up to 40 weeks for the participants who will stop after the active blinded extension period and up to 136 weeks for the participants who will continue in the long-term extension period. * The number of visits will be up to 23 for the participants who will stop after the active blinded extension period and up to 71 for the participants who will continue in the long-term extension period.
Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of Duvakitug in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2026-10-13
Completion Date
2030-11-08
Last Updated
2026-09-10
Healthy Volunteers
No
Conditions
Interventions
Duvakitug
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Placebo
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection