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New nanobody drug shows promise for painful skin condition

NCT ID NCT05849922

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 study tested a new drug called SAR442970 in 86 adults with moderate to severe hidradenitis suppurativa, a chronic skin condition causing painful lumps. The drug is a Nanobody that targets two inflammatory proteins. Researchers compared it to a placebo to see if it could reduce skin inflammation and abscesses over 16 weeks. The goal was to find a new treatment option for people who haven't responded well to antibiotics.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAR442970 (a Nanobody drug that targets TNF and OX40L)
What this could lead to
If successful, this could point toward a new treatment option for people with moderate to severe hidradenitis suppurativa.
What could go wrong
This is an early proof-of-concept study with only 86 participants, so results may not apply to everyone. The drug may not work better than placebo or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

86 people

The number who actually took part.

Started

Jun 2023

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hidradenitis suppurativa

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hidradenitis suppurativa

Contacts and locations

Locations

  • Advanced Medical Research PC Site Number : 8400002

    Sandy Springs, Georgia, 30328, United States

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

    Houston, Texas, 77004, United States

  • Clinical Partners, LLC Site Number : 8400010

    Johnston, Rhode Island, 02919, United States

  • ForCare Clinical Research Site Number : 8400006

    Tampa, Florida, 33613, United States

  • Investigational Site Number : 0360002

    Liverpool, New South Wales, 2170, Australia

  • Investigational Site Number : 0360003

    Woolloongabba, Queensland, 4102, Australia

  • Investigational Site Number : 0560001

    Leuven, 3000, Belgium

  • Investigational Site Number : 1240001

    Barrie, Ontario, L4M 7G1, Canada

  • Investigational Site Number : 1240002

    London, Ontario, N6H 5L5, Canada

  • Investigational Site Number : 1240004

    Newmarket, Ontario, L3Y 5G8, Canada

  • Investigational Site Number : 1240007

    Québec, G1V 4T3, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7640881, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8420383, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7580206, Chile

  • Investigational Site Number : 2030001

    Prague, 10034, Czechia

  • Investigational Site Number : 2030002

    Praha 5 - Motol, 15006, Czechia

  • Investigational Site Number : 2030003

    Ostrava - Poruba, 70852, Czechia

  • Investigational Site Number : 2080001

    Roskilde, 4000, Denmark

  • Investigational Site Number : 2500001

    Lyon, 69003, France

  • Investigational Site Number : 2500002

    Nice, 06200, France

  • Investigational Site Number : 2500003

    Reims, 51100, France

  • Investigational Site Number : 2760001

    Münster, 48149, Germany

  • Investigational Site Number : 2760002

    Frankfurt am Main, 60590, Germany

  • Investigational Site Number : 2760004

    Mainz, 55131, Germany

  • Investigational Site Number : 2760005

    Berlin, 10117, Germany

  • Investigational Site Number : 2760008

    Bochum, 44791, Germany

  • Investigational Site Number : 3000001

    Athens, 16121, Greece

  • Investigational Site Number : 3000003

    Athens, 12462, Greece

  • Investigational Site Number : 3800001

    Milan, Lombardy, 20122, Italy

  • Investigational Site Number : 3800002

    Rozzano, Lombardy, 20089, Italy

  • Investigational Site Number : 3800003

    Catania, 95123, Italy

  • Investigational Site Number : 5280001

    Groningen, 9713 GZ, Netherlands

  • Investigational Site Number : 5280003

    Rotterdam, 3015 GD, Netherlands

  • Investigational Site Number : 6160001

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • Investigational Site Number : 6160002

    Wroclaw, 51-685, Poland

  • Investigational Site Number : 6160003

    Wroclaw, 50-566, Poland

  • Investigational Site Number : 6160004

    Lodz, 90265, Poland

  • Investigational Site Number : 7240001

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

  • Investigational Site Number : 7240003

    Barcelona, Barcelona [Barcelona], 08041, Spain

  • Investigational Site Number : 7240004

    Manises, Valencia, 46940, Spain

  • Investigational Site Number : 7240005

    Córdoba, 14004, Spain

  • Investigational Site Number : 7240006

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Investigational Site Number : 7520001

    Älvsjö, 125 44, Sweden

  • Medical Dermatology Specialists Site Number : 8400007

    Phoenix, Arizona, 85006, United States

  • Renstar Medical Research Site Number : 8400011

    Ocala, Florida, 34470, United States

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