Hidradenitis Suppurativa study: Brivekimig
Official title Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT07170917
What this study is testing
What is Brivekimig?
Brivekimig is an investigational subcutaneous injectable medicine being studied as a potential treatment for moderate to severe hidradenitis suppurativa.
Also referred to as SAR442970.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out how well brivekimig works and how safe it is at different doses for people with moderate to severe hidradenitis suppurativa.
- Who it's for
- Adults who have moderate to severe hidradenitis suppurativa.
- What's involved
- Participants are randomly given either brivekimig or a placebo in a double‑blind setup, with regular clinic visits and safety tests.
- Time commitment
- Up to about 152 weeks of treatment, and up to 164 weeks total if you join the long‑term extension, with scheduled visits throughout.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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
- Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of...
- 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.
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
- 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.
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...
- 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
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Northridge, California, United States
- Fort Myers, Florida, United States
- Miami, Florida, United States
- Miramar, Florida, United States
- Atlanta, Georgia, United States
- Savannah, Georgia, United States
- West Des Moines, Iowa, United States
- Baton Rouge, Louisiana, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Johnston, Rhode Island, United States
- Myrtle Beach, South Carolina, United States
- Dallas, Texas, United States
- Liverpool, New South Wales, Australia
- Melbourne, Victoria, Australia
- Edmonton, Alberta, Canada
+ 52 more site(s).
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, but 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Northridge, California, United States; Fort Myers, Florida, United States; Miami, Florida, United States; Miramar, Florida, United States and 66 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.