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A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

NCT07225569

RecruitingPhase 2

Sponsor: Sanofi

Conditions: Hidradenitis Suppurativa

Interventions: SAR445399, Placebo

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, France

This is a multinational, randomized, double-blind, placebo-controlled, Phase 2, dose finding study to evaluate the efficacy and safety of different doses of SAR445399 in adult participants with moderate to severe hidradenitis suppurativa. The purpose of this study is to assess the efficacy and safety of two doses of SAR445399 compared with placebo in adult participants with moderate to severe hidradenitis suppurativa. The study duration (per participant) will be up to 46 weeks with a total of 16 visits. The treatment duration will be 32 weeks which includes 16-week double-blinded initial treatment period and a 16-week treatment-blinded extension period.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

* Participants with a history of signs and symptoms consistent with 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 inguino-crural fold), with at least 1 body site being Hurley Stage II or III.
* Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit.
* Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics or 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 in the biologic-naïve stratum must be naïve to any prior use of biologic therapy with a potential impact on HS; Participants in the biologic-experienced stratum must have documented history of use of at least one dose of biologic therapy for HS.

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 or suspected current immunosuppression
* History of solid organ transplant or stem cell transplant.
* History of splenectomy
* 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.
* Any other medical condition or severe, concomitant illness, including psychiatric illness and substance abuse, that may present an unreasonable risk to the study participants, make participants unreliable or may interfere with study assessments

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Locations (66)
  • Scottsdale, Arizona, United States
  • North Hollywood, California, United States
  • Boynton Beach, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Fort Myers, Florida, United States
  • Hollywood, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Cumming, Georgia, United States
  • Fayetteville, Georgia, United States
  • Overland Park, Kansas, United States
  • Louisville, Kentucky, United States
  • New York, New York, United States
  • The Woodlands, Texas, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Sydney, New South Wales, Australia
  • Brussels, Belgium
  • Ghent, Belgium
  • Liège, Belgium
  • Salvador, Estado de Bahia, Brazil
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Sherbrooke, Quebec, Canada
  • Regina, Saskatchewan, Canada
  • Saskatoon, Saskatchewan, Canada
  • Beijing, China
  • Changsha, China
  • + 36 more on CT.gov