A study to test the efficacy and safety of SAR442970 in adults with hidradenitis suppurativa

Phase 1

Conditions: Hidradenitis suppurativa
MedDRA version: 20.0Level: LLTClassification code: 10020041Term: Hidradenitis suppurativa Class: 10040785
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: CTIS2022-502370-17-00

Lead Sponsor: Sanofi-Aventis Research & Development

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 84

Inclusion Criteria

Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 1 year 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 and small molecule immunosuppressive-naïve or TNF-experienced, Participant must have a total abscess and inflammatory nodule (AN) count of =3 at the baseline visit, Participant must have a draining tunnel count of =20 at the baseline visit, Participant must have a C-reactive protein (CRP) >3 mg/L at the screening visit, Participant who is a candidate for systemic treatment per Investigator’s judgment

Exclusion Criteria

Any other active skin disease or condition (eg, bacterial, fungal or viral infection) that may interfere with assessment of HS, History of solid organ transplant, History of splenectomy, History of moderate to severe congestive heart failure, Receipt of a live vaccine 12 week prior to baseline visit or receipt of a killed vaccine 2 weeks prior to baseline visit, 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, or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured, Laboratory exclusion criteria apply, Participants with a diagnosis of inflammatory conditions other than HS, Presence of active suicidal ideation, or positive suicide behavior or participant has a lifetime history of suicide attempt, or participant has had suicidal ideation in the past 6 months as indicated by a positive response using the screening or baseline version of the Columbia-Suicide Severity Rating Scale (C-SSRS) or as assessed by the Investigator through participant interview and review of medical history, A history of an adverse event (AE) 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, Female participants who are breastfeeding or considering becoming pregnant during the study, History (within last 2 years prior to baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator, History of recurrent or recent serious infection, Known history of or suspected significant current immunosuppression

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of SAR442970 during the double blind, placebo-controlled period in the biologic and small molecule immunosuppressive-naïve subgroup of participants with hidradenitis suppurativa (HS);Secondary Objective: To evaluate the efficacy and safety of SAR442970 in the biologic and small molecule immunosuppressive-naïve subgroup and TNF-experienced subgroup of participants with HS, To evaluate the effect of SAR442970 on pain in participants with HS, To evaluate the pharmacokinetics (PK) of SAR442970 and anti-drug antibodies to SAR442970 in the biologic and small molecule immunosuppressive-naïve subgroup and TNF-experienced subgroup of participants with HS;Primary end point(s): Percentage of biologic and small molecule immunosuppressive naïve participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR50)

Secondary Outcome Measures