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NOT YET RECRUITING
NCT07812116
PHASE2

A Study to Investigate Efficacy and Safety of Duvakitug in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Sponsor: Sanofi

View on ClinicalTrials.gov

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

DRUG

Duvakitug

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection

DRUG

Placebo

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection