Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Drug: Placebo
- Registration Number
- NCT07170917
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 188
- 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.
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brivekimig dose regimen A Brivekimig Participants will receive Brivekimig dose regimen A. Brivekimig dose regimen C Brivekimig Participants will receive Brivekimig dose regimen C. Placebo Placebo Participants will receive Brivekimig matching placebo. Brivekimig dose regimen B Brivekimig Participants will receive Brivekimig dose regimen B.
- Primary Outcome Measures
Name Time Method Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) Up to Week 16 Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from Baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count.
- Secondary Outcome Measures
Name Time Method Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) Up to Week 16 Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) is defined as ≥50% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count.
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) Up to Week 16 Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) is defined as ≥90% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count.
Change from Baseline in draining tunnel count at Week 16. From Baseline to Week 16 Change in absolute score from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16 From Baseline to Week 16 The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. A high score signifies severe disease.
Percentage of participants achieving response on the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale from the HS Symptom Assessment Questionnaire (HS-SAQ skin pain NRS) at week 8 From Baseline to Week 8 The Hidradenitis Suppurativa Symptom Assessment Questionnaire (HS-SAQ) is a 7-item scale comprising unidimensional numeric rating scale (NRS) items assessing symptoms of HS. The HS-SAQ Skin Pain is based on worst skin pain in a 24-hour recall period (daily assessment is averaged over 7-day period). HS-SAQ skin pain NRS response is defined as ≥3-unit reduction from baseline in the weekly average of daily HS-SAQ Skin Pain NRS.
Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) total score at Week 16. From Baseline to Week 16 The Hidradenitis Suppurativa Quality of Life is a 17-item content-validated questionnaire with a 7-day recall period. It is scored by summing items to create a total score (0 to 68) with higher score indicating more severe impact on QoL.
Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16. From Baseline to Week 16 The Dermatology Life Quality Index (DLQI) is a 10-item dermatology specific health related quality of life (HRQoL) instrument. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
Number of participants with treatment-emergent adverse events (TEAE), serious adverse events (SAE) and laboratory anomalies. Up to End of Study (approximately 60 weeks) Serum brivekimig concentration throughout the study. Up to End of Study (approximately 60 weeks) Incidence of treatment-emergent (TE) anti-drug antibody responses. Up to End of Study (approximately 60 weeks)