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New shot could ease painful skin condition

NCT ID NCT06411899

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study tested a drug called sonelokimab, given as a shot under the skin, in 422 adults with moderate to severe hidradenitis suppurativa (a painful skin condition causing boils and abscesses). Participants were randomly assigned to receive either the drug or a placebo for up to 16 weeks. The main goal was to see if the drug could reduce the number of inflamed lumps 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 given as a shot 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.

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

422 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

    Pleven, 5800, Bulgaria

  • Clinical SIte

    Halle, 06108, Germany

  • Clinical Site

    Los Angeles, California, 90024, United States

  • Clinical Site

    Northridge, California, 91325, United States

  • Clinical Site

    Sacramento, California, 95815, United States

  • Clinical Site

    San Diego, California, 92123, United States

  • Clinical Site

    Coral Gables, Florida, 33134, United States

  • Clinical Site

    Coral Springs, Florida, 33071, United States

  • Clinical Site

    Hollywood, Florida, 33201, United States

  • Clinical Site

    Margate, Florida, 33063, United States

  • Clinical Site

    Miami, Florida, 33161, United States

  • Clinical Site

    Tampa, Florida, 33607, United States

  • Clinical Site

    Macon, Georgia, 31217, United States

  • Clinical Site

    Sandy Springs, Georgia, 30328, United States

  • Clinical Site

    West Dundee, Illinois, 60118, United States

  • Clinical Site

    Columbus, Indiana, 47201, United States

  • Clinical Site

    New Albany, Indiana, 47150, United States

  • Clinical Site

    Louisville, Kentucky, 40241, United States

  • Clinical Site

    Metairie, Louisiana, 70006, United States

  • Clinical Site

    Boston, Massachusetts, 02116, United States

  • Clinical Site

    Boston, Massachusetts, 02215, United States

  • Clinical Site

    Dearborn, Michigan, 48126, United States

  • Clinical Site

    Warren, Michigan, 48088, United States

  • Clinical Site

    Las Vegas, Nevada, 89119, United States

  • Clinical Site

    New York, New York, 10012, United States

  • Clinical Site

    The Bronx, New York, 10467, United States

  • Clinical Site

    Boardman, Ohio, 44512, United States

  • Clinical Site

    Dayton, Ohio, 45324, United States

  • Clinical Site

    Mayfield Heights, Ohio, 44124, United States

  • Clinical Site

    Oklahoma City, Oklahoma, 73118, United States

  • Clinical Site

    Charleston, South Carolina, 29425, United States

  • Clinical Site

    Nashville, Tennessee, 37215, United States

  • Clinical Site

    Frisco, Texas, 75034, United States

  • Clinical Site

    Houston, Texas, 77004, United States

  • Clinical Site

    Houston, Texas, 77082, United States

  • Clinical Site

    South Jordan, Utah, 84095, United States

  • Clinical Site

    Forest, Virginia, 24551, United States

  • Clinical Site

    Mill Creek, Washington, 98012, United States

  • Clinical Site

    Sofia, 1407, Bulgaria

  • Clinical Site

    Sofia, 1527, Bulgaria

  • Clinical Site

    Sofia, 1606, Bulgaria

  • Clinical Site

    Edmonton, Alberta, T5J 3S9, Canada

  • Clinical Site

    Edmonton, Alberta, T6H 4J8, Canada

  • Clinical Site

    Sherwood Park, Alberta, T8H 0P1, Canada

  • Clinical Site

    Winnipeg, Manitoba, R3M 3Z4, Canada

  • Clinical Site

    Fredericton, New Brunswick, E3B 1G9, Canada

  • Clinical Site

    Barrie, Ontario, L4M 7G1, Canada

  • Clinical Site

    London, Ontario, N6H 5L5, Canada

  • Clinical Site

    Markham, Ontario, L3P 1X3, Canada

  • Clinical Site

    Newmarket, Ontario, L3Y 5G8, Canada

  • Clinical Site

    Toronto, Ontario, M2N 3A6, Canada

  • Clinical Site

    Toronto, Ontario, M5A3R6, Canada

  • Clinical Site

    Montreal, Quebec, H1Y 3L1, Canada

  • Clinical Site

    Québec, Quebec, G1W 4R4, Canada

  • Clinical Site

    Sherbrooke, Quebec, J1G 1X9, Canada

  • Clinical Site

    Berlin, 10789, Germany

  • Clinical Site

    Bochum, 44805, Germany

  • Clinical Site

    Buxtehude, 21614, Germany

  • Clinical Site

    Erlangen, 91054, Germany

  • Clinical Site

    Essen, 45147, Germany

  • Clinical Site

    Frankfurt, 60590, Germany

  • Clinical Site

    Hanover, 30159, Germany

  • Clinical Site

    Langenau, 89129, Germany

  • Clinical Site

    Mahlow, 15831, Germany

  • Clinical Site

    München, 80337, Germany

  • Clinical Site

    Münster, 48149, Germany

  • Clinical Site

    Oldenburg, 26133, Germany

  • Clinical Site

    Wuppertal, 42283, Germany

  • Clinical Site

    Budapest, 1036, Hungary

  • Clinical Site

    Debrecen, 4031, Hungary

  • Clinical Site

    Debrecen, 4032, Hungary

  • Clinical Site

    Pécs, 7632, Hungary

  • Clinical Site

    Brescia, 25123, Italy

  • Clinical Site

    Catania, 95123, Italy

  • Clinical Site

    Chieti, 66100, Italy

  • Clinical Site

    Cona, 44124, Italy

  • Clinical Site

    Florence, 50125, Italy

  • Clinical Site

    Milan, 20122, Italy

  • Clinical Site

    Modena, 41124, Italy

  • Clinical Site

    Naples, 80131, Italy

  • Clinical Site

    Perugia, 06129, Italy

  • Clinical Site

    Pisa, 56126, Italy

  • Clinical Site

    Rome, 00168, Italy

  • Clinical Site

    Rozzano, 20089, Italy

  • Clinical Site

    Torino, 10126, Italy

  • Clinical Site

    Torrette, 60020, Italy

  • Clinical Site

    Oslo, 0372, Norway

  • Clinical Site

    Bialystok, 15-453, Poland

  • Clinical Site

    Gdansk, 80-214, Poland

  • Clinical Site

    Krakow, 30-002, Poland

  • Clinical Site

    Krakow, 30-727, Poland

  • Clinical Site

    Lodz, 90-265, Poland

  • Clinical Site

    Lodz, 90-436, Poland

  • Clinical Site

    Lublin, 20-573, Poland

  • Clinical Site

    Ossy, 42-624, Poland

  • Clinical Site

    Poznan, 60-529, Poland

  • Clinical Site

    Sosnowiec, 41-200, Poland

  • Clinical Site

    Szczecin, 71-500, Poland

  • Clinical Site

    Warsaw, 00-710, Poland

  • Clinical Site

    Warsaw, 02-507, Poland

  • Clinical Site

    Warsaw, 02-692, Poland

  • Clinical Site

    Wroclaw, 51-503, Poland

  • Clinical Site

    Lisbon, 1169-050, Portugal

  • Clinical Site

    Lisbon, 1649-035, Portugal

  • Clinical Site

    Porto, 4050-342, Portugal

  • Clinical Site

    Cardiff, CF14 4XW, United Kingdom

  • Clinical Site

    Dudley, DY1 2HQ, United Kingdom

  • Clinical Site

    Leeds, LS9 7TF, United Kingdom

  • Clinical Site

    Salford, M6 8HD, United Kingdom

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