Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa

Purpose

This is a Phase 2b, global, multicenter, sequential, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study in participants with moderate to severe hidradenitis suppurativa. The purpose of this study is to assess the efficacy and safety of brivekimig in a dose-ranging study of participants with moderate to severe HS. Study details include: The study duration (per participant) will be up to approximately 60 weeks for participants not transitioning into the long-term extension (LTE) study and will be up to approximately 52 weeks for participants transitioning into the LTE study. The randomized treatment duration will be up to approximately 48 weeks.

Condition

  • Hidradenitis Suppurativa

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants with a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months 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 inguinocrural fold), one of which must be Hurley Stage II or Hurley Stage III. - Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, demonstrated intolerance to antibiotics, or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history. - Participants must be either biologic-naive or biologic-experienced. - Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline visit. - Participant must have a draining tunnel count of ≤20 at the Baseline visit.

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 recurrent or recent serious infection - Known history of significant immunosuppression - History of solid organ transplant or stem cell transplant - History of splenectomy - History of moderate to severe congestive heart failure. - History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease - Participants with a history of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured - History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol - Active suicidality and therefore significant suicide risk, as judged by the Investigator - A history of an Adverse Event (AE) attributed to or related to anti-TNF therapy (examples include, but are not limited, to serum sickness or anaphylaxis) for an HS or non-HS indication that would contraindicate readministration of an anti-TNF class therapy - Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study - History (within last 2 years prior to Baseline visit) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Brivekimig dose regimen A
Participants will receive Brivekimig dose regimen A.
  • Drug: Brivekimig
    - Pharmaceutical form: Solution for injection in vial - Route of administration: Subcutaneous injection
    Other names:
    • SAR442970
Experimental
Brivekimig dose regimen B
Participants will receive Brivekimig dose regimen B.
  • Drug: Brivekimig
    - Pharmaceutical form: Solution for injection in vial - Route of administration: Subcutaneous injection
    Other names:
    • SAR442970
Experimental
Brivekimig dose regimen C
Participants will receive Brivekimig dose regimen C.
  • Drug: Brivekimig
    - Pharmaceutical form: Solution for injection in vial - Route of administration: Subcutaneous injection
    Other names:
    • SAR442970
Placebo Comparator
Placebo
Participants will receive Brivekimig matching placebo.
  • Drug: Placebo
    - Pharmaceutical form: Solution for injection in vial - Route of administration: Subcutaneous injection

Recruiting Locations

Northridge Clinical Trials - Northridge- Site Number : 8400005
Northridge 5377985, California 5332921 91325

FXM Clinical Research - Miami- Site Number : 8400017
Miami 4164138, Florida 4155751 33175

FXM Clinical Research Miramar, LLC - Site Number: 8400004
Miramar 4164601, Florida 4155751 33027

Advanced Medical Research - Atlanta- Site Number : 8400011
Atlanta 4180439, Georgia 4197000 30342

Georgia Skin & Cancer Clinic- Site Number : 8400009
Savannah 4221552, Georgia 4197000 31419

Louisiana Dermatology Associates- Site Number : 8400006
Baton Rouge 4315588, Louisiana 4331987 70809

Clinical Partners- Site Number : 8400002
Johnston 8604682, Rhode Island 5224323 02919

Alliance for Multispecialty Research - Myrtle Beach- Site Number : 8400018
Myrtle Beach 4588718, South Carolina 4597040 29588

Alpine Research Association- Site Number : 8400008
Layton 5777107, Utah 5549030 84041

More Details

NCT ID
NCT07170917
Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
contact-us@sanofi.com