A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa (HS OBTAIN)

Sanofi

Status and phase: Active, not recruiting; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Placebo; Drug: SAR442970

Study type: Interventional

Funder types: Industry

Identifiers

NCT05849922

U1111-1280-6493 (Registry Identifier)

2022-502370-17 (Other Identifier)

ACT16852

Details and patient eligibility

About

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.

Full description

The study duration will be up to 40 weeks.

Enrollment: 86 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 2 patient groups, including a placebo group

SAR442970

Experimental group

Description:

Participants will receive SAR442970 once every two weeks (Q2W) in Period A (Day 1 to Week 16). Participants will receive SAR442970 Q2W in Period B (Up to Week 28).

Treatment:

Drug: SAR442970

Placebo

Placebo Comparator group

Description:

Participants will receive placebo Q2W in Period A (Day 1 to Week 16). Participants will receive SAR442970 Q2W in Period B (Up to Week 28).

Treatment:

Drug: Placebo