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New drug shows promise for painful skin condition

NCT ID NCT04762277

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether spesolimab, an anti-inflammatory drug, can reduce painful lumps and abscesses in adults with moderate to severe hidradenitis suppurativa. Fifty-two participants were randomly assigned to receive either spesolimab or a placebo for about 3 months. Doctors counted skin lesions to compare results between the groups. The trial has completed, and results may help determine if larger studies are warranted.

What this could mean

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

Active substance
spesolimab
What this could lead to
If it works, this could point toward a new treatment option for people with hidradenitis suppurativa who don't respond to current therapies.
What could go wrong
This is a small, early-phase trial with only 52 participants. The drug may not prove more effective than placebo, and side effects are still being studied.

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

52 people

The number who actually took part.

Started

Apr 2021

Finished

Apr 2022

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 years and older

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: * Male or female adult patients, 18 years of age or older * Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedures * Moderate to severe Hidradenitis suppurativa (HS), based on International Hidradenitis Suppurativa Severity Score System (IHS4) criteria, for at least 1 year prior to the baseline visit, as determined by the investigator through participant interview and/or review of the medical history. (If IHS4 scoring is not available, equivalent scoring based on scoring systems as HS-PGA or Hurley are acceptable based on documented investigator assessment) * HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, perineal) * Biologic naive or TNF inhibitor (TNFi)-failure for HS * Inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS in the last 1 year, as per investigator discretion. This is not applicable for TNFi-failure patients * Total abscess and inflammatory nodule (AN) count of greater than or equal to 5 * Total draining fistula count of less than or equal to 20 Further inclusion criteria apply Exclusion Criteria: * Presence of active skin lesions other than HS that interfere with the assessment of HS * Use of restricted medications as below: * Topical corticosteroids over HS lesions within 1 week of Visit 2 * Systemic antibiotics within 4 weeks of visit 2 * Systemic non-biologic immunomodulatory and/or immunosuppressive agents use for HS within 4 weeks (or 5 half lives, whichever is longer) of visit 2 * Biologic agents use within 12 weeks or 5 half-lives, whichever is longer, prior to visit 2 * Opioid analgesics within 2 weeks of visit 2 * Live virus vaccine within 6 weeks of visit 2 * Prior exposure to any immunosuppressive biologic other than TNFi for HS * Prior exposure to Interleukin 36 Receptor (IL-36R) inhibitors including spesolimab * Treatment with any investigational device or investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to visit 2 * Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating * History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients * Patient with a transplanted organ (with exception of a corneal transplant \> 12 weeks prior to screening) or who have ever received stem cell therapy (e.g., Remestemcel-L) Further exclusion criteria apply

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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

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56126, Italy

  • CLI Reims Bezannes

    Bezannes, 51430, France

  • Cityclinic Medical and Psychological Clinic Matusiak Partnership

    Wroclaw, 50-566, Poland

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250, United States

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Dr. S. K. Siddha Medicine Professional Corporation

    Newmarket, Ontario, L3Y 5G8, Canada

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD, Netherlands

  • HOP Edouard Herriot

    Lyon, 69003, France

  • HOP Larrey

    Toulouse, 31059, France

  • Haukeland Universitetssykehus

    Bergen, N-5021, Norway

  • Holdsworth House Medical Practice

    Sydney, New South Wales, 2010, Australia

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08026, Spain

  • Katholisches Klinikum Bochum gGmbH

    Bochum, 44791, Germany

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905, United States

  • Non-Public Health Care Facility LABDERM

    Ossy, 42624, Poland

  • Nordlandssykehuset HF, Bodø

    Bodø, 8005, Norway

  • Oslo Universitetssykehus HF, Rikshospitalet

    Oslo, N-0372, Norway

  • Ospedali Riuniti di Ancona

    Ancona, 60123, Italy

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • Städtisches Klinikum Dessau

    Dessau, 06847, Germany

  • ULB Hopital Erasme

    Brussels, 1070, Belgium

  • Unity Clinical Research

    Oklahoma City, Oklahoma, 73118, United States

  • University Hospital Ostrava

    Ostrava, 708 52, Czechia

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60596, Germany

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