Phase 2
Completed N=86
A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa
Source: ClinicalTrials.gov NCT05849922 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.