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New shot could ease painful skin condition

NCT ID NCT06411379

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a drug called sonelokimab in 418 adults with moderate to severe hidradenitis suppurativa, a skin condition that causes painful lumps and abscesses. Participants received either the drug or a placebo injection for 16 weeks. The goal was to see if sonelokimab reduces the number of inflamed lumps and draining tunnels by at least 75%.

What this could mean

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

Active substance
Sonelokimab (a drug injected under the skin)
What this could lead to
If it works, this could provide a new treatment option for people with moderate to severe hidradenitis suppurativa, reducing painful lumps and abscesses.
What could go wrong
This is a completed Phase 3 trial, but results are not yet public. The drug may not work better than placebo, and side effects are possible. It is not a cure, and ongoing treatment may be needed.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

418 people

The number who actually took part.

Started

May 2024

Finished

May 2026

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: 1. Participants must be at least 18 years of age at the time of signing the informed consent. 2. Participants who are diagnosed with hidradenitis suppurativa as determined by the investigator and have a history of signs and symptoms of hidradenitis suppurativa for at least 6 months before signing the informed consent. 3. Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of hidradenitis suppurativa (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS), in the investigator's opinion. 4. Participants who have a total AN count of ≥5. 5. Participants who have HS lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (ie, be Hurley Stage II or III). Exclusion Criteria: 1. Participants with a known hypersensitivity to sonelokimab or any of its excipients. 2. Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS. 3. Participants with underlying conditions that, in the opinion of the investigator, potentially places the participant at unacceptable risk. 4. Participants with current severe or uncontrolled disease(s) that put(s) the participant at increased risk in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol. 5. Participants with any other known autoimmune disease or any medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS. 6. Participants with a gastrointestinal condition including inflammatory bowel disease or diagnosis of ulcerative colitis or Crohn's disease.

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Conditions

The condition(s) this trial relates to.

hidradenitis hidradenitis suppurativa skin disease caused by bacterial infection skin disorder Suppuration sweat gland disorder

As listed by the trial registrant

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

Hidradenitis suppurativa

Contacts and locations

Locations

  • Clinical SIte

    Brest, 29200, France

  • Clinical Site

    Birmingham, Alabama, 35244, United States

  • Clinical Site

    North Little Rock, Arkansas, 72117, United States

  • Clinical Site

    Fountain Valley, California, 92708, United States

  • Clinical Site

    Santa Monica, California, 90404, United States

  • Clinical Site

    Aventura, Florida, 33180, United States

  • Clinical Site

    Hialeah, Florida, 33012, United States

  • Clinical Site

    Miami, Florida, 33136, United States

  • Clinical Site

    Ocala, Florida, 34470, United States

  • Clinical Site

    Tampa, Florida, 33613, United States

  • Clinical Site

    Skokie, Illinois, 60077, United States

  • Clinical Site

    Plainfield, Indiana, 46168, United States

  • Clinical Site

    Murray, Kentucky, 42071, United States

  • Clinical Site

    Baton Rouge, Louisiana, 70809, United States

  • Clinical Site

    Baltimore, Maryland, 21287, United States

  • Clinical Site

    Ann Arbor, Michigan, 48109-5314, United States

  • Clinical Site

    Canton, Michigan, 48187, United States

  • Clinical Site

    Clarkston, Michigan, 48346, United States

  • Clinical Site

    Waterford, Michigan, 48328, United States

  • Clinical Site

    New Brighton, Minnesota, 55112, United States

  • Clinical Site

    Omaha, Nebraska, 68144, United States

  • Clinical Site

    Las Vegas, Nevada, 89145, United States

  • Clinical Site

    New York, New York, 10003, United States

  • Clinical Site

    Fargo, North Dakota, 58103, United States

  • Clinical Site

    Columbus, Ohio, 43213, United States

  • Clinical Site

    Murfreesboro, Tennessee, 37130, United States

  • Clinical Site

    Dallas, Texas, 75390-8565, United States

  • Clinical Site

    Plano, Texas, 75025, United States

  • Clinical Site

    San Antonio, Texas, 78213, United States

  • Clinical Site

    Morgantown, West Virginia, 26505, United States

  • Clinical Site

    Milwaukee, Wisconsin, 53226, United States

  • Clinical Site

    Ghent, 9000, Belgium

  • Clinical Site

    Leuven, 3000, Belgium

  • Clinical Site

    Liège, 4000, Belgium

  • Clinical Site

    Woluwe-Saint-Lambert, 1200, Belgium

  • Clinical Site

    Sofia, 1431, Bulgaria

  • Clinical Site

    Sofia, 1463, Bulgaria

  • Clinical Site

    Sofia, 1510, Bulgaria

  • Clinical Site

    Sofia, 1606, Bulgaria

  • Clinical Site

    Stara Zagora, 6003, Bulgaria

  • Clinical Site

    Calgary, Alberta, T3E 0B2, Canada

  • Clinical Site

    Edmonton, Alberta, T6G 1C3, Canada

  • Clinical Site

    Guelph, Ontario, N1L 0B7, Canada

  • Clinical Site

    Peterborough, Ontario, K9J 5K2, Canada

  • Clinical Site

    Richmond Hill, Ontario, L4B 1A5, Canada

  • Clinical Site

    Toronto, Ontario, M4E 1R7, Canada

  • Clinical Site

    Windsor, Ontario, N8W 1E6, Canada

  • Clinical Site

    Saskatoon, Saskatchewan, S7K 2C1, Canada

  • Clinical Site

    Ostrava, 708 52, Czechia

  • Clinical Site

    Prague, 110 00, Czechia

  • Clinical Site

    Prague, 15006, Czechia

  • Clinical Site

    Antony, 92160, France

  • Clinical Site

    Besançon, 25030, France

  • Clinical Site

    Dijon, 21000, France

  • Clinical Site

    Le Mans, 72037, France

  • Clinical Site

    Lyon, 69003, France

  • Clinical Site

    Montpellier, 34295, France

  • Clinical Site

    Rouen, 76031, France

  • Clinical Site

    Saint-Mandé, 94160, France

  • Clinical Site

    Saint-Priest-en-Jarez, 42270, France

  • Clinical Site

    Toulouse, 31400, France

  • Clinical Site

    Augsburg, 86179, Germany

  • Clinical Site

    Bad Bentheim, 48455, Germany

  • Clinical Site

    Berlin, 10117, Germany

  • Clinical Site

    Bielefeld, 33647, Germany

  • Clinical Site

    Bochum, 44791, Germany

  • Clinical Site

    Bramsche, 49565, Germany

  • Clinical Site

    Darmstadt, 64283, Germany

  • Clinical Site

    Dresden, 01307, Germany

  • Clinical Site

    Gera, 07548, Germany

  • Clinical Site

    Hamburg, 20246, Germany

  • Clinical Site

    Kiel, 24105, Germany

  • Clinical Site

    Lübeck, 23538, Germany

  • Clinical Site

    Würzburg, 97080, Germany

  • Clinical Site

    Dublin, D04 T6F4, Ireland

  • Clinical Site

    Rotterdam, 3015 GD, Netherlands

  • Clinical Site

    Chorzów, 41-500, Poland

  • Clinical Site

    Katowice, 40-611, Poland

  • Clinical Site

    Kielce, 25-316, Poland

  • Clinical Site

    Olsztyn, 10-229, Poland

  • Clinical Site

    Poznan, 61-731, Poland

  • Clinical Site

    Szczecin, 70-332, Poland

  • Clinical Site

    Warsaw, 02-953, Poland

  • Clinical Site

    Wroclaw, 50566, Poland

  • Clinical Site

    Trnava, 91702, Slovakia

  • Clinical Site

    Alcorcón, 28922, Spain

  • Clinical Site

    Alicante, 03010, Spain

  • Clinical Site

    Badalona, 08916, Spain

  • Clinical Site

    Barcelona, 08003, Spain

  • Clinical Site

    Barcelona, 08036, Spain

  • Clinical Site

    Barcelona, 08041, Spain

  • Clinical Site

    Cadiz, 11009, Spain

  • Clinical Site

    Córdoba, 14004, Spain

  • Clinical Site

    Granada, 18012, Spain

  • Clinical Site

    Granada, 18014, Spain

  • Clinical Site

    Granollers, 08402, Spain

  • Clinical Site

    Madrid, 28006, Spain

  • Clinical Site

    Madrid, 28007, Spain

  • Clinical Site

    Madrid, 28041, Spain

  • Clinical Site

    Madrid, 28046, Spain

  • Clinical Site

    Manises, 46940, Spain

  • Clinical Site

    Málaga, 29010, Spain

  • Clinical Site

    Santiago de Compostela, 15706, Spain

  • Clinical Site

    Seville, 41009, Spain

  • Clinical Site

    Valencia, 46014, Spain

  • Clinical Site

    Valencia, 46026, Spain

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