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

A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study Assessing the Efficacy and Safety of an Anti-TNF-OX40L NANOBODY® Molecule, SAR442970, in Participants With Moderate to Severe Hidradenitis Suppurativa

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.

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: SAR442970; Drug: Placebo

Detailed Description

The study duration was up to 40 weeks.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Investigational Site Number : 0360002
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Investigational Site Number : 0360003
• Belgium
  • Leuven, Belgium, 3000
    • Investigational Site Number : 0560001
• Canada
  • Québec, Canada, G1V 4T3
    • Investigational Site Number : 1240007
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Investigational Site Number : 1240001
    • London, Ontario, Canada, N6H 5L5
      • Investigational Site Number : 1240002
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Investigational Site Number : 1240004
• Chile
  • Reg Metropolitana de Santiago
    • Santiago, Reg Metropolitana de Santiago, Chile, 7580206
      • Investigational Site Number : 1520003
    • Santiago, Reg Metropolitana de Santiago, Chile, 7640881
      • Investigational Site Number : 1520001
    • Santiago, Reg Metropolitana de Santiago, Chile, 8420383
      • Investigational Site Number : 1520002
• Czechia
  • Ostrava - Poruba, Czechia, 70852
    • Investigational Site Number : 2030003
  • Prague, Czechia, 10034
    • Investigational Site Number : 2030001
  • Praha 5 - Motol, Czechia, 15006
    • Investigational Site Number : 2030002
• Denmark
  • Roskilde, Denmark, 4000
    • Investigational Site Number : 2080001
• France
  • Lyon, France, 69003
    • Investigational Site Number : 2500001
  • Nice, France, 06200
    • Investigational Site Number : 2500002
  • Reims, France, 51100
    • Investigational Site Number : 2500003
• Germany
  • Berlin, Germany, 10117
    • Investigational Site Number : 2760005
  • Bochum, Germany, 44791
    • Investigational Site Number : 2760008
  • Frankfurt am Main, Germany, 60590
    • Investigational Site Number : 2760002
  • Mainz, Germany, 55131
    • Investigational Site Number : 2760004
  • Münster, Germany, 48149
    • Investigational Site Number : 2760001
• Greece
  • Athens, Greece, 12462
    • Investigational Site Number : 3000003
  • Athens, Greece, 16121
    • Investigational Site Number : 3000001
• Italy
  • Catania, Italy, 95123
    • Investigational Site Number : 3800003
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Investigational Site Number : 3800001
    • Rozzano, Lombardy, Italy, 20089
      • Investigational Site Number : 3800002
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Investigational Site Number : 5280001
  • Rotterdam, Netherlands, 3015 GD
    • Investigational Site Number : 5280003
• Poland
  • Lodz, Poland, 90265
    • Investigational Site Number : 6160004
  • Wroclaw, Poland, 50-566
    • Investigational Site Number : 6160003
  • Wroclaw, Poland, 51-685
    • Investigational Site Number : 6160002
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-507
      • Investigational Site Number : 6160001
• Spain
  • Córdoba, Spain, 14004
    • Investigational Site Number : 7240005
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 08041
      • Investigational Site Number : 7240003
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28046
      • Investigational Site Number : 7240006
    • Madrid / Madrid, Madrid, Comunidad de, Spain, 28007
      • Investigational Site Number : 7240001
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Investigational Site Number : 7240004
• Sweden
  • Älvsjö, Sweden, 125 44
    • Investigational Site Number : 7520001
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Medical Dermatology Specialists Site Number : 8400007
  • Florida
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research Site Number : 8400011
    • Tampa, Florida, United States, 33613
      • ForCare Clinical Research Site Number : 8400006
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Advanced Medical Research PC Site Number : 8400002
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC Site Number : 8400010
  • Texas
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies, LTD. LLP Site Number : 8400003

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• Laboratory exclusion criteria applied.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAR442970; 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; 1 mL extractable volume of 150 mg/mL SAR442970 filled in 2 mL glass vial
Placebo Comparator: Placebo; 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; 1 mL extractable volume of placebo filled in 2 mL glass vial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Period A (DB Period): Time to Onset of Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50)	Time to onset of achieving HiSCR50 during the DB period was defined as the time from randomization to the first time of achieving HiSCR50 by Week 16. HiSCR50 was defined as >=50% reduction from baseline in the total 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.	Up to Week 16
Period A (DB Period): Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16	The HiSCR75 was used for assessing HS treatment effectiveness in controlling inflammatory manifestations in the population. HiSCR75 was defined as >=75% reduction from baseline in the total 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.	Week 16
Period A (DB Period): Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR90) at Week 16	The HiSCR90 was used for assessing HS treatment effectiveness in controlling inflammatory manifestations in the population. HiSCR90 was defined as >=90% reduction from baseline in the total 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.	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	The IHS4 was a validated tool to assess HS severity. The determination of IHS4 required counting inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. IHS4 score was calculated as: (number of inflammatory nodules multiplied by 1) + (number of abscesses multiplied by 2) + (number of draining tunnels multiplied by 4). A categorial IHS4 score was derived from this weighted score with total score range: mild: (<=3), moderate: (4 to 10) and severe: (>=11); higher scores indicated worse outcomes. Improvement in IHS4 by >=1 IHS4 stage was considered clinically meaningful.	Week 16
Period A (DB Period): Change From Baseline at Week 16 in Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4)	The IHS4 was a validated tool to assess HS severity. The determination of IHS4 required counting inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. IHS4 score was calculated as: (number of inflammatory nodules multiplied by 1) + (number of abscesses multiplied by 2) + (number of draining tunnels multiplied by 4). A categorial IHS4 score was derived from this weighted score with total score range: mild: (<=3), moderate: (4 to 10) and severe: (>=11); higher scores indicated worse outcomes. Baseline was defined as the last available value before the first dose of DB study drug.	Baseline (Day 1) and Week 16
Period A (DB Period): Percentage of Participants Who Experienced a Flare Relative to Baseline at Week 16	HS flare was defined as >=25% increase in AN count with a >=2 increase from baseline by Week 16. Baseline was defined as the last available value before the first dose of DB study drug.	Baseline (Day 1) and Week 16
Period A (DB Period): Percentage of Participants Who Achieved International Hidradenitis Suppurativa Severity Score System (IHS4)-55 at Week 16	The IHS4 was a validated tool to assess HS severity. The determination of IHS4 required counting inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. IHS4 score was calculated as: (number of inflammatory nodules multiplied by 1) + (number of abscesses multiplied by 2) + (number of draining tunnels multiplied by 4). A categorial IHS4 score was derived from this weighted score with total score range: mild: (<=3), moderate: (4 to 10) and severe: (>=11); higher scores indicated worse outcomes. IHS4-55 was defined as a 55% reduction in IHS4 score from baseline. Baseline was defined as the last available value before the first dose of DB study drug.	Week 16
Period A (DB Period) + Period B (OLE Period): Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Special Interest (TEAESIs)	An AE as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were AEs that developed, worsened or became serious during the TE period. An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required.	Period A was assessed from first dose of study drug (Day 1 in Period A) up to last dose of study drug + 75 days, up to 192 days; Period B was assessed from first dose in Period B to last dose of study drug + 75 days, up to 168 days
Period A (DB Period): Percentage of Participants Who Achieved at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in Weekly Average of Daily Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) at Week 16	The HS-Skin Pain NRS was a unidimensional numeric rating scale (NRS) that allowed for rapid measure of skin pain that was administered multiple times with minimal administrative burden. The HS-Skin Pain NRS had a 24-hour recall period and was completed as a daily diary, ideally at the same time each day (evening) throughout the treatment period. Participants were asked to complete the HS-Skin Pain NRS for 7 consecutive days leading up to the baseline visit with a minimum of 4 completions in their daily diary. The HS-Skin Pain NRS was scored on a 0 to 10 scale; 0: no skin pain and 10: worst skin pain possible. Higher scores indicated worse outcomes. Baseline was defined as the last available value before the first dose of DB study drug.	Baseline (Day 1) and Week 16
Period A (DB Period) + Period B (OLE Period): Serum SAR442970 Concentrations	Blood samples were collected at specified timepoints for assessment of serum SAR442970 concentrations.	Baseline (Day 1), Weeks 4, 8, 10, 12 and 16 (Period A); Weeks 18, 20 and 28 (Period B)
Period B (OLE Period) + Period A+B (DB+OLE Period): Number of Participants With Anti-SAR442970 Antibody Response	Serum samples were collected at specified timepoints for assessment of anti-SAR442970 antibody response. Treatment-emergent anti-drug antibody (ADA) were defined as participants with at least 1 treatment-induced/boosted ADA at any time after first study drug administration up to the last available ADA sample collection. Number of participants with treatment-emergent ADA response are presented.	Period B: Placebo-SAR442970 arm were assessed from first dose of study drug in Period B up to approximately 20 weeks. Period A+B: SAR442970-SAR442970 arm were assessed from first dose of study drug in Period A up to 36 weeks

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

General Publications

• 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.

Helpful Links

• ACT16852 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Actual): August 22, 2024
• Study Completion (Actual): January 9, 2025

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa
• Other Study ID Numbers: ACT16852; U1111-1280-6493 (Registry Identifier: ICTRP); 2022-502370-17 (EudraCT Number: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No