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

Conditions

• Hidradenitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Duvakitug — DRUG
  Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
• Placebo — DRUG
  Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection

Study Details

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.

Key Dates

First listed

Sep 10, 2026

Start date

Oct 13, 2026

Status verified

Oct 2026

Primary completion

Jun 16, 2028

Completion

Nov 8, 2030

Study Design

Enrollment

156 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Duvakitug Dose Regimen A
  Participants will receive Duvakitug dose regimen A as per protocol
• Experimental: Duvakitug Dose Regimen B
  Participants will receive Duvakitug dose regimen B as per protocol
• Placebo Comparator: Placebo
  Participants will receive Duvakitug matching placebo as per protocol

Primary Outcome Measure

Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [ Time Frame: At Week 16 ]

Central Contacts

• Trial Transparency email recommended (Toll free for US & Canada)
  800-633-1610
  [email protected]

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