NCT07170917 · Sanofi
Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
(BRIGHTEN)
What this study is about
This is a Phase 2b, global, conducted at multiple hospitals, sequential, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, parallel group, dose-ranging study in participants with moderate to severe hidradenitis suppurativa.
View original scientific description
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 the main 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Phoenix, Arizona
- Scottsdale, Arizona
- Northridge, California
- Miami, Florida
- Miramar, Florida
- Atlanta, Georgia
- Savannah, Georgia
- West Des Moines, Iowa
- Baton Rouge, Louisiana
- St Louis, Missouri
- Las Vegas, Nevada
- Johnston, Rhode Island
And 3 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2026 · Source of record for eligibility and locations