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Brivekimig for the treatment of moderate to severe hidradenitis suppurativa
EU CTIS ID: 2025-522333-61-00
What this study is testing
Evaluate the efficacy of different dosing regimens of brivekimig for the treatment of study participants with moderate to severe Hidradenitis suppurativa.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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.
You likely can't join if
- - Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
- - 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 re-administration 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.
- - History of recurrent or recent serious infection
See the full eligibility 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.
- - Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
- - 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 re-administration 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.
- - 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- United States
- United Arab Emirates
- Australia
- Chile
- China
- Japan
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; United States; United Arab Emirates; Australia; Chile and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.