A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa

NCT ID: NCT05849922

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-06
• Study Completion Date: 2025-01-09

Brief Summary

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.

Detailed Description

The study duration will be up to 40 weeks.

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SAR442970

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).

Group Type: EXPERIMENTAL

SAR442970

Intervention Type: DRUG

1 mL extractable volume of 150 mg/mL SAR442970 filled in 2 mL glass vial

Placebo

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 mL extractable volume of placebo filled in 2 mL glass vial

Interventions

SAR442970

1 mL extractable volume of 150 mg/mL SAR442970 filled in 2 mL glass vial

Intervention Type: DRUG

Placebo

1 mL extractable volume of placebo filled in 2 mL glass vial

Intervention Type: DRUG

Eligibility Criteria

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

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Medical Dermatology Specialists Site Number : 8400007

Phoenix, Arizona, United States

Renstar Medical Research Site Number : 8400011

Ocala, Florida, United States

ForCare Clinical Research Site Number : 8400006

Tampa, Florida, United States

Advanced Medical Research PC Site Number : 8400002

Sandy Springs, Georgia, United States

Clinical Partners, LLC Site Number : 8400010

Johnston, Rhode Island, United States

Center for Clinical Studies, LTD. LLP Site Number : 8400003

Houston, Texas, United States

Investigational Site Number : 0360002

Liverpool, New South Wales, Australia

Investigational Site Number : 0360005

Westmead, New South Wales, Australia

Investigational Site Number : 0360003

Woolloongabba, Queensland, Australia

Investigational Site Number : 0360001

Carlton, Victoria, Australia

Investigational Site Number : 0560001

Leuven, , Belgium

Investigational Site Number : 0560002

Woluwe-Saint-Lambert, , Belgium

Investigational Site Number : 1240001

Barrie, Ontario, Canada

Investigational Site Number : 1240002

London, Ontario, Canada

Investigational Site Number : 1240004

Newmarket, Ontario, Canada

Investigational Site Number : 1240007

Québec, , Canada

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 2030003

Ostrava - Poruba, , Czechia

Investigational Site Number : 2030001

Prague, , Czechia

Investigational Site Number : 2030002

Praha 5 - Motol, , Czechia

Investigational Site Number : 2080001

Roskilde, , Denmark

Investigational Site Number : 2500001

Lyon, , France

Investigational Site Number : 2500002

Nice, , France

Investigational Site Number : 2500003

Reims, , France

Investigational Site Number : 2500004

Saint-Mandé, , France

Investigational Site Number : 2760005

Berlin, , Germany

Investigational Site Number : 2760008

Bochum, , Germany

Investigational Site Number : 2760002

Frankfurt am Main, , Germany

Investigational Site Number : 2760004

Mainz, , Germany

Investigational Site Number : 2760001

Münster, , Germany

Investigational Site Number : 3000003

Athens, , Greece

Investigational Site Number : 3000001

Athens, , Greece

Investigational Site Number : 3800001

Milan, Lombardy, Italy

Investigational Site Number : 3800002

Rozzano, Lombardy, Italy

Investigational Site Number : 3800003

Catania, , Italy

Investigational Site Number : 5280002

Breda, , Netherlands

Investigational Site Number : 5280001

Groningen, , Netherlands

Investigational Site Number : 5280003

Rotterdam, , Netherlands

Investigational Site Number : 6160001

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number : 6160004

Lodz, , Poland

Investigational Site Number : 6160003

Wroclaw, , Poland

Investigational Site Number : 6160002

Wroclaw, , Poland

Investigational Site Number : 7240003

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240006

Madrid, Madrid, Comunidad de, Spain

Investigational Site Number : 7240001

Madrid / Madrid, Madrid, Comunidad de, Spain

Investigational Site Number : 7240004

Manises, Valencia, Spain

Investigational Site Number : 7240005

Córdoba, , Spain

Investigational Site Number : 7520001

Älvsjö, , Sweden

Countries

United States; Australia; Belgium; Canada; Chile; Czechia; Denmark; France; Germany; Greece; Italy; Netherlands; Poland; Spain; Sweden

References

Lin J, Radhakrishnan J. What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials? J Am Soc Nephrol. 2025 Feb 3;36(8):1652-1654. doi: 10.1681/ASN.0000000648. No abstract available.

Reference Type: DERIVED

PMID: 39899371 (View on PubMed)

Other Identifiers

U1111-1280-6493

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022-502370-17

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACT16852

Identifier Type: -

Identifier Source: org_study_id