A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa
Investigation of an Investigational Medication for Hidradenitis Suppurativa
Study Overview
This is a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study is to evaluate the efficacy and safety of SAR442970 compared to placebo.
Study Details
The study duration will be up to 40 weeks.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Hidradenitis Suppurativa
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Age: 18 years - 70 years
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Gender: All
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 recurrent or recent serious infection
- Known history of or suspected significant current immunosuppression
- 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
- 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 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
- 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
- Laboratory exclusion criteria apply
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
This study investigates the effects of an investigational medication on adults with moderate to severe hidradenitis suppurativa (HS). Hidradenitis suppurativa is a long-term skin condition that causes small, painful lumps under the skin. These lumps can break open, causing tunnels under the skin. The purpose of this study is to determine how well the investigational medication works and how safe it is compared to a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Participants in this study will be randomly assigned to receive either the investigational medication or a placebo. They will be monitored for any changes in their condition and any side effects they experience. The study will involve regular check-ups and assessments to track the efficacy and safety of the treatment.
- Who can participate: Adults with a history of hidradenitis suppurativa for at least one year and lesions in at least two areas can participate. Participants should have tried antibiotics without success and may be experienced with certain immune therapies; exclusions include other active skin diseases, recent serious infections, or significant immunosuppression history.
- Study details: Participants will receive either the investigational medication or a placebo. They will be monitored for changes in their condition and any side effects. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
- Study Timelines: The study will last 40 weeks.