Recruiting
Phase 2

Duvakitug

Sponsor:

Sanofi

Code:

NCT07812116

Conditions

Hidradenitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Duvakitug

Placebo

Study Details

Brief 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.

Conditions

Hidradenitis

Study ID

NCT07812116

Start date

Oct 19, 2026

Status verified date

Nov, 2026

Completion date

Nov 8, 2030

Anticipated

Primary completion date

Jun 16, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 6 months prior to Baseline Visit
  • 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), with at least 1 body site being Hurley Stage II or III.
  • Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit.
  • Participants must have had an inadequate response to a course of a systemic antibiotics for treatment of HS, exhibited recurrence after discontinuation of antibiotics or demonstrated intolerance to antibiotics, or has a contraindication to systemic antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
  • Participants must have a prior HS treatment history consistent with the following:

  • For the biologic and immunosuppressive small molecule-naïve subgroup, participants must have no history of treatment with any approved or investigational biologic therapy or small molecule immunosuppressive therapy with potential efficacy for HS.
  • For the biologic and immunosuppressive small molecule-experienced subgroup, participants must have a history of treatment with at least 1 biologic or immunosuppressive small molecule therapy with potential efficacy for HS.

Exclusion Criteria:

  • Participants are excluded from the study if any of the following criteria apply:
  • Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
  • History of systemic hypersensitivity or anaphylaxis to any biologic therapy
  • History of recurrent or recent serious infection
  • Known history of or suspected significant current immunosuppression
  • History of solid organ transplant or stem cell transplant.
  • History of splenectomy
  • History of malignancy or suspicion of malignancy within 5 years prior to the Screening Visit (except for in situ cervical carcinoma that has been treated by surgery and completely cured, or basal cell carcinoma or squamous cell carcinoma that has been excised and completely cured)
  • History within the 2 years prior to Baseline Visit of prescription drug or substance abuse, including alcohol, considered significant by the Investigator.
  • Any medical or psychiatric condition which, in the opinion of the Investigator could be considered uncontrolled, unstable, or likely to progress in a clinically relevant manner and may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments.
  • Any other medical condition or severe, concomitant illness, including psychiatric illness and substance abuse, that may present an unreasonable risk to the study participants, make participants unreliable, or may interfere with study assessments.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Design

Enrollment

156 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Duvakitug

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

Placebo

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610Contact-US@sanofi.com

Locations

Cahaba Dermatology & Skin Health Center- Site Number : 8400004

Recruiting

Birmingham, Alabama, United States, 35244

Florida International Research Center- Site Number : 8400002

Recruiting

Miami, Florida, United States, 33173

Investigational Site Number : 1240002

Recruiting

Peterborough, Ontario, Canada, K9J 5K2

Investigational Site Number : 1240006

Recruiting

Richmond Hill, Ontario, Canada, L4B 1L1

More Information

Sponsor

Sanofi

Last update posted

Nov 9, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by Sanofi on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.