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Phase 2, randomized, parallel-group, double-blind, placebo-controlled study of sonelokimab in patients with active moderate to severe hidradenitis suppurativa

NCT ID NCT05322473

NEW 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 09, 2026

Summary

This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa.

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

234 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 2023

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. Participant is ≥18 years of age; 2. Participant has been diagnosed with hidradenitis suppurativa as determined by the investigator and has a history of signs and symptoms of hidradenitis suppurativa dating back at least 6 months prior to the Screening Visit; 3. Participant has a total abscess and/or inflammatory nodule (AN) count of ≥5; 4. Participant has hidradenitis suppurativa lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (i.e., be Hurley Stage II or III); 5. Participant 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; 6. Participant must be, in the opinion of the investigator, at both the Screening Visit and study treatment initiation, a suitable candidate for treatment with adalimumab per approved local product information. Exclusion Criteria: 1. Participants with known hypersensitivity to sonelokimab or any of its excipients; 2. Participants with known hypersensitivity to adalimumab or any of its excipients; 3. Participant has a draining fistula count of ≥20 at the Screening Visit; 4. Participant has any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of hidradenitis suppurativa; 5. Prior exposure to more than 2 biologic response modifiers; 6. Participant has a diagnosis of ulcerative colitis or Crohn's disease.

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Conditions

The condition(s) this trial relates to.

folliculitis 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

    Fountain Valley, California, 92708, United States

  • Clinical Site

    Los Angeles, California, 90056, United States

  • Clinical Site

    Miami, Florida, 33136, United States

  • Clinical Site

    Ormond Beach, Florida, 32127, United States

  • Clinical Site

    St. Petersburg, Florida, 33709, United States

  • Clinical Site

    Tampa, Florida, 33613, United States

  • Clinical Site

    Indianapolis, Indiana, 46250, United States

  • Clinical Site

    Beverly, Massachusetts, 01915, United States

  • Clinical Site

    Boston, Massachusetts, 02215, United States

  • Clinical Site

    Omaha, Nebraska, 68144, United States

  • Clinical Site

    New York, New York, 10003, United States

  • Clinical Site

    Philadelphia, Pennsylvania, 19103, United States

  • Clinical Site

    Charleston, South Carolina, 29425, United States

  • Clinical Site

    Nashville, Tennessee, 37215, United States

  • Clinical Site

    Bellaire, Texas, 77401, United States

  • Clinical Site

    Sofia, 1407, Bulgaria

  • Clinical Site

    Sofia, 1431, Bulgaria

  • Clinical Site

    Sofia, 1463, Bulgaria

  • Clinical Site

    Stara Zagora, 6000, Bulgaria

  • Clinical Site

    Calgary, Alberta, T3E 0B2, Canada

  • Clinical Site

    Winnipeg, Manitoba, R3M 3Z4, Canada

  • Clinical Site

    Fredericton, New Brunswick, E3B 1G9, Canada

  • Clinical Site

    St. John's, Newfoundland and Labrador, A1A 4Y3, Canada

  • Clinical Site

    Hamilton, Ontario, L8L 3C3, Canada

  • Clinical Site

    London, Ontario, N6H 5L5, Canada

  • Clinical Site

    Markham, Ontario, L3P 1X2, Canada

  • Clinical Site

    Newmarket, Ontario, L3Y 5G8, Canada

  • Clinical Site

    Peterborough, Ontario, K9J 5K2, Canada

  • Clinical Site

    Saskatoon, Saskatchewan, S7K 2C1, Canada

  • Clinical Site

    Bad Bentheim, 48455, Germany

  • Clinical Site

    Berlin, 10117, Germany

  • Clinical Site

    Berlin, 10789, Germany

  • Clinical Site

    Berlin, 13595, Germany

  • Clinical Site

    Bochum, 44791, Germany

  • Clinical Site

    Darmstadt, 64283, Germany

  • Clinical Site

    Dresden, 01307, Germany

  • Clinical Site

    Frankfurt, 60590, Germany

  • Clinical Site

    Hamburg, 20246, Germany

  • Clinical Site

    Kiel, 24105, Germany

  • Clinical Site

    Lübeck, 23538, Germany

  • Clinical Site

    Mahlow, 15831, Germany

  • Clinical Site

    München, 80337, Germany

  • Clinical Site

    Münster, 48149, Germany

  • Clinical Site

    Dublin, D04 T6F4, Ireland

  • Clinical Site

    Bergen op Zoom, 4624, Netherlands

  • Clinical Site

    Rotterdam, 3015 GD, Netherlands

  • Clinical Site

    Gdansk, 80-214, Poland

  • Clinical Site

    Krakow, 31-033, Poland

  • Clinical Site

    Lodz, 90-265, Poland

  • Clinical Site

    Olsztyn, 10-341, Poland

  • Clinical Site

    Ossy, 42-624, Poland

  • Clinical Site

    Ostrowiec Świętokrzyski, 27-400, Poland

  • Clinical Site

    Poznan, 60-681, Poland

  • Clinical Site

    Warsaw, 02-507, Poland

  • Clinical Site

    Warsaw, 02-692, Poland

  • Clinical Site

    Wroclaw, 50566, Poland

  • Clinical Site

    Wroclaw, 51318, Poland

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