Phase 2
N=86
A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Bottom Line
View on ClinicalTrials.gov: NCT05849922 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Period A (DB Period): Percentage of Biologic and Small Molecule Immunosuppressive-Naïve Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 — 39.1; 66.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SAR442970 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Period A (DB Period): Percentage of Biologic and Small Molecule Immunosuppressive-Naïve Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 |
39.1; 66.7 | — |
| SECONDARY Period A (DB Period): Time to Onset of Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) |
113.00; 29.00 | — |
| SECONDARY Period A (DB Period): Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16 |
21.7; 54.2 | — |
| SECONDARY Period A (DB Period): Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR90) at Week 16 |
8.7; 31.3 | — |
| SECONDARY 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 |
56.5; 83.3 | — |
| SECONDARY Period A (DB Period): Change From Baseline at Week 16 in Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) |
-7.3; -18.1 | — |
| SECONDARY Period A (DB Period): Percentage of Participants Who Experienced a Flare Relative to Baseline at Week 16 |
30.4; 16.7 | — |
| SECONDARY Period A (DB Period): Percentage of Participants Who Achieved International Hidradenitis Suppurativa Severity Score System (IHS4)-55 at Week 16 |
34.8; 64.6 | — |
| SECONDARY 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) |
15; 45; 14; 30; 0; 0 | — |
| SECONDARY 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 |
40.0; 40.6 | — |
| SECONDARY Period A (DB Period) + Period B (OLE Period): Serum SAR442970 Concentrations |
0.00; 6451.21; 7729.59; 8091.69; 9486.51; 8844.81 | — |
| SECONDARY Period B (OLE Period) + Period A+B (DB+OLE Period): Number of Participants With Anti-SAR442970 Antibody Response |
18; 45 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT05849922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.