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

NCT05849922 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: ACT16852U1111-1280-64932022-502370-17
• Study Type: interventional
• Target: 86
• Locations: 15 countries
• Sites: 45

Brief Summary

This was a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study was to evaluate the efficacy and safety of SAR442970 compared to placebo.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Period A (DB Period): Percentage of Biologic and Small Molecule Immunosuppressive-Naïve Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16

  The HiSCR50 was used for assessing HS treatment effectiveness in controlling inflammatory manifestations in the population. HiSCR50 was defined as \>=50% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining tunnel count. Baseline was defined as the last available value before the first dose of DB study drug. Percentages are rounded off to the tenth decimal place.

  Week 16

Secondary Outcomes (11)

• Period A (DB Period): Time to Onset of Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50)

  Up to Week 16

• Period A (DB Period): Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16

  Week 16

• Period A (DB Period): Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR90) at Week 16

  Week 16

• Period A (DB Period): Percentage of Participants Who Experienced Improvement by at Least 1 International Hidradenitis Suppurativa Severity Score System (IHS4) Stage at Week 16

  Week 16

• Period A (DB Period): Change From Baseline at Week 16 in Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4)

  Baseline (Day 1) and Week 16

Study Arms (2)

SAR442970

EXPERIMENTAL

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

Drug: SAR442970

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

SAR442970 DRUG

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

SAR442970

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 1 year prior to Baseline.
• Participants had to 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 had to be Hurley Stage II or Hurley Stage III.
• Participant had to 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 had a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
• Participants had to be either biologic and small molecule immunosuppressive-naïve or TNF-experienced.
• Participant had to have a total abscess and inflammatory nodule (AN) count of ≥3 at the Baseline visit.
• Participant had to have a draining tunnel count of ≤20 at the Baseline visit.
• Participant had to have a C-reactive protein (CRP) \>3 mg/L at the screening visit.
• Participant who was a candidate for systemic treatment per Investigator's judgment.

You may not qualify if:

• Any other active skin disease or condition (eg, bacterial, fungal or viral infection) that might have interfered 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 had a lifetime history of suicide attempt, or participant had 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 included, but were 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, contraindicated participation in the study
• Female participants who were 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (45)

Medical Dermatology Specialists Site Number : 8400007

Phoenix, Arizona, 85006, United States

Location

Renstar Medical Research Site Number : 8400011

Ocala, Florida, 34470, United States

Location

ForCare Clinical Research Site Number : 8400006

Tampa, Florida, 33613, United States

Location

Advanced Medical Research PC Site Number : 8400002

Sandy Springs, Georgia, 30328, United States

Location

Clinical Partners, LLC Site Number : 8400010

Johnston, Rhode Island, 02919, United States

Location

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

Houston, Texas, 77004, United States

Location

Investigational Site Number : 0360002

Liverpool, New South Wales, 2170, Australia

Location

Investigational Site Number : 0360003

Woolloongabba, Queensland, 4102, Australia

Location

Investigational Site Number : 0560001

Leuven, 3000, Belgium

Location

Investigational Site Number : 1240001

Barrie, Ontario, L4M 7G1, Canada

Location

Investigational Site Number : 1240002

London, Ontario, N6H 5L5, Canada

Location

Investigational Site Number : 1240004

Newmarket, Ontario, L3Y 5G8, Canada

Location

Investigational Site Number : 1240007

Québec, G1V 4T3, Canada

Location

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, 7580206, Chile

Location

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 7640881, Chile

Location

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 8420383, Chile

Location

Investigational Site Number : 2030003

Ostrava - Poruba, 70852, Czechia

Location

Investigational Site Number : 2030001

Prague, 10034, Czechia

Location

Investigational Site Number : 2030002

Praha 5 - Motol, 15006, Czechia

Location

Investigational Site Number : 2080001

Roskilde, 4000, Denmark

Location

Investigational Site Number : 2500001

Lyon, 69003, France

Location

Investigational Site Number : 2500002

Nice, 06200, France

Location

Investigational Site Number : 2500003

Reims, 51100, France

Location

Investigational Site Number : 2760005

Berlin, 10117, Germany

Location

Investigational Site Number : 2760008

Bochum, 44791, Germany

Location

Investigational Site Number : 2760002

Frankfurt am Main, 60590, Germany

Location

Investigational Site Number : 2760004

Mainz, 55131, Germany

Location

Investigational Site Number : 2760001

Münster, 48149, Germany

Location

Investigational Site Number : 3000003

Athens, 12462, Greece

Location

Investigational Site Number : 3000001

Athens, 16121, Greece

Location

Investigational Site Number : 3800001

Milan, Lombardy, 20122, Italy

Location

Investigational Site Number : 3800002

Rozzano, Lombardy, 20089, Italy

Location

Investigational Site Number : 3800003

Catania, 95123, Italy

Location

Investigational Site Number : 5280001

Groningen, 9713 GZ, Netherlands

Location

Investigational Site Number : 5280003

Rotterdam, 3015 GD, Netherlands

Location

Investigational Site Number : 6160001

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Investigational Site Number : 6160004

Lodz, 90265, Poland

Location

Investigational Site Number : 6160003

Wroclaw, 50-566, Poland

Location

Investigational Site Number : 6160002

Wroclaw, 51-685, Poland

Location

Investigational Site Number : 7240003

Barcelona, Barcelona [Barcelona], 08041, Spain

Location

Investigational Site Number : 7240006

Madrid, Madrid, Comunidad de, 28046, Spain

Location

Investigational Site Number : 7240001

Madrid / Madrid, Madrid, Comunidad de, 28007, Spain

Location

Investigational Site Number : 7240004

Manises, Valencia, 46940, Spain

Location

Investigational Site Number : 7240005

Córdoba, 14004, Spain

Location

Investigational Site Number : 7520001

Älvsjö, 125 44, Sweden

Location

Related Publications (1)

• 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.

  PMID: 39899371 DERIVED

Related Links

• ACT16852 Plain Language Results Summary

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610 ext 6#

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 9, 2023
• Study Start: June 6, 2023
• Primary Completion: August 22, 2024
• Study Completion: January 9, 2025
• Last Updated: January 29, 2026
• Results First Posted: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

AU (2); IT (3); NL (2); PL (4); DK (1); CL (3); ES (5); US (6); GR (2); CA (4); SE (1); DE (5); BE (1); CZ (3); FR (3)