Hidradenitis suppurativa
Conditions
Interventions
Drug: Brivekimig (SAR442970)
Pharmaceutical form: Solution for injection in vial, Route of administration: Subcutaneous injection
Drug: Placebo
Pharmaceutical form: Solution for injection in vial,
Sponsors
Obara Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants with a diagnosis of moderate to severe 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
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-tumor necrosis factor (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [Time Frame: Up to Week 16] HiSCR75 is defined as >=75% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants achieving HiSCR50 [Time Frame: Up to Week 16] HiSCR50 is defined as >=50% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count. 2. Percentage of participants achieving HiSCR90 [Time Frame: Up to Week 16] HiSCR90 is defined as >=90% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count. 3. Change from Baseline in draining tunnel count at Week 16 [Time Frame: From Baseline to Week 16] 4. Change in absolute score from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16 [Time Frame: 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. 5. 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 [Time Frame: From Baseline to Week 8] The HS-SAQ is a 7-item scale comprising unidimensional 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. 6. Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) total score at Week 16 [Time Frame: From Baseline to Week 16] The HiSQOL 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. 7. Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16 [Time Frame: From Baseline to Week 16] The DLQI is a 10-item dermatology specific health related quality o | — |
Countries
Japan, TBD
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed