CompletedPhase 2
A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa
Key facts
- Who runs it
- Sanofi
- Where
- Houston, Johnston, Ocala, Phoenix, Sandy Springs, and Tampa, United StatesSee the 6 sitesAlso in 14 other countries, 46 sites
- Trial code
- NCT05849922
- EU 2022-502370-17-00
- U1111-1280-6493
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 86 people enrolled
- Started
- 6 Jun 2023
- Ended
- 9 Jan 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- SAR442970
- Placebo
- Record updated
- 29 January 2026
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 24 criteriaShow less
Who can take part
- 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
Who cannot take part
- Receipt of a live vaccine 12 week prior to Baseline visit or receipt of a killed vaccine 2 weeks prior to Baseline visit
- History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
- 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
- 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
- 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
- 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
- Laboratory exclusion criteria applied; The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial
- Female participants who were breastfeeding or considering becoming pregnant during the study
Where in United States
Also in 14 other countries, 46 sites
- Center for Clinical Studies, LTD. LLP Site Number : 8400003Houston, United StatesNo longer taking part
- Clinical Partners, LLC Site Number : 8400010Johnston, United StatesNo longer taking part
- Renstar Medical Research Site Number : 8400011Ocala, United StatesNo longer taking part
- Medical Dermatology Specialists Site Number : 8400007Phoenix, United StatesNo longer taking part
- Advanced Medical Research PC Site Number : 8400002Sandy Springs, United StatesNo longer taking part
- Tampa, FloridaHospital not named in the registryNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- SAR442970Treatment being tested
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).
- PlaceboPlacebo, for comparison
Participants received placebo Q2W in Period A (Day 1 to Week 16). Participants received SAR442970 Q2W in Period B (Up to Week 28).
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Record updated
- 29 January 2026