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New hope for HS sufferers: Long-Term drug trial expands

NCT ID NCT07007637

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looks at the long-term safety and effectiveness of a drug called sonelokimab for people with moderate to severe hidradenitis suppurativa (HS), a painful skin condition. About 835 adults and teens who completed an earlier sonelokimab study will receive the drug for an extended period. The goal is to see if the drug remains safe and helps control HS symptoms over time.

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

About 835 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

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

12 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: * Participants who have completed a parental study (M1095-HS-301 or M1095-HS-302 \[adult studies\] or M1095-HS-304 \[adolescent study\]) and are eligible to continue to receive sonelokimab at the time of completing the parental study. * Female participants are eligible to participate if they are not pregnant or breastfeeding * Male participants must be willing to use a condom when sexually active with a partner of childbearing potential . Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment. Exclusion Criteria: * Participants who meet any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study. * Participants who have ongoing or planned to use one or more of the prohibited HS or non-HS treatments specified in the protocol. * Participants who plan to participate in another interventional study for a drug or device during this study.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    166 sites in 16 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinical Site

    Birmingham, Alabama, 35244, United States

  • Clinical Site

    North Little Rock, Arkansas, 72117, United States

  • Clinical Site

    Los Angeles, California, 90404, United States

  • Clinical Site

    Northridge, California, 91325, United States

  • Clinical Site

    Aventura, Florida, 33180, United States

  • Clinical Site

    Coral Gables, Florida, 33134, United States

  • Clinical Site

    Hialeah, Florida, 33012, United States

  • Clinical Site

    Hollywood, Florida, 33021-6746, United States

  • Clinical Site

    Miami, Florida, 33136, United States

  • Clinical Site

    Miami, Florida, 33163, United States

  • Clinical Site

    Ocala, Florida, 34471, United States

  • Clinical Site

    Tampa, Florida, 33607, United States

  • Clinical Site

    Tampa, Florida, 33613, United States

  • Clinical Site

    Macon, Georgia, 31217, United States

  • Clinical Site

    Sandy Springs, Georgia, 30328, United States

  • Clinical Site

    Skokie, Illinois, 60077, 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

    Plainfield, Indiana, 46168, United States

  • Clinical Site

    Louisville, Kentucky, 40241, United States

  • Clinical Site

    Murray, Kentucky, 42071, 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

    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, 89148, United States

  • Clinical Site

    New York, New York, 10003, United States

  • Clinical Site

    New York, New York, 10012, United States

  • Clinical Site

    The Bronx, New York, 10467, United States

  • Clinical Site

    Fargo, North Dakota, 58103, United States

  • Clinical Site

    Boardman, Ohio, 44512, United States

  • Clinical Site

    Columbus, Ohio, 43213, United States

  • Clinical Site

    Dayton, Ohio, 45324, United States

  • Clinical Site

    Oklahoma City, Oklahoma, 73118, United States

  • Clinical Site

    Murfreesboro, Tennessee, 37130, United States

  • Clinical Site

    Dallas, Texas, 75235, United States

  • Clinical Site

    Dallas, Texas, 75246, United States

  • Clinical Site

    Houston, Texas, 77004, United States

  • Clinical Site

    San Antonio, Texas, 78213, United States

  • Clinical Site

    San Antonio, Texas, 78218, United States

  • Clinical Site

    South Jordan, Utah, 84095, United States

  • Clinical Site

    Mill Creek, Washington, 98012, United States

  • Clinical Site

    Morgantown, West Virginia, 26505, United States

  • Clinical Site

    Ghent, 9000, Belgium

  • Clinical Site

    Leuven, 3000, Belgium

  • Clinical Site

    Pleven, Ontario, 5800, Bulgaria

  • Clinical Site

    Sofia, Ontario, 1463, Bulgaria

  • Clinical Site

    Stara Zagora, Ontario, 6003, Bulgaria

  • Clinical Site

    Sofia, 1407, Bulgaria

  • Clinical Site

    Sofia, 1431, Bulgaria

  • Clinical Site

    Sofia, 1510, Bulgaria

  • Clinical Site

    Sofia, 1606, Bulgaria

  • Clinical Site

    Calgary, Alberta, T3E 0B2, Canada

  • Clinical Site

    Edmonton, Alberta, T6G 1C3, 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

    Guelph, Ontario, N0B 2J0, Canada

  • Clinical Site

    London, Ontario, N6H 5L5, Canada

  • Clinical Site

    Markham, Ontario, L3P 1X3, Canada

  • Clinical Site

    Newmarket, Ontario, L3Y 5G8, Canada

  • Clinical Site

    Peterborough, Ontario, K9J 5K2, Canada

  • Clinical Site

    Toronto, Ontario, M2N 3A6, Canada

  • Clinical Site

    Toronto, Ontario, M4E 1R7, Canada

  • Clinical Site

    Toronto, Ontario, M5A3R6, Canada

  • Clinical Site

    Montreal, Quebec, H1Y 3L1, Canada

  • Clinical Site

    Québec, Quebec, G1W 4R4, Canada

  • Clinical Site

    Saskatoon, Saskatchewan, S7K 2C1, Canada

  • Clinical Site

    Ostrava, 708 52, Czechia

  • Clinical Site

    Prague, 110 00, Czechia

  • Clinical Site

    Brest, 29200, France

  • Clinical Site

    Lyon, 69003, France

  • Clinical Site

    Saint-Mandé, 94160, France

  • Clinical Site

    Saint-Priest-en-Jarez, 42270, France

  • Clinical Site

    Halle, Saale, 06108, Germany

  • Clinical Site

    Augsburg, 86179, Germany

  • Clinical Site

    Bad Bentheim, 48455, Germany

  • Clinical Site

    Berlin, 10117, Germany

  • Clinical Site

    Berlin, 10789, Germany

  • Clinical Site

    Bielefeld, 33647, Germany

  • Clinical Site

    Bochum, 44791, Germany

  • Clinical Site

    Bochum, 44793, Germany

  • Clinical Site

    Bramsche, 49565, Germany

  • Clinical Site

    Darmstadt, 64283, Germany

  • Clinical Site

    Dresden, 01307, Germany

  • Clinical Site

    Erlangen, 91054, Germany

  • Clinical Site

    Frankfurt, 60590, Germany

  • Clinical Site

    Hanover, 30159, Germany

  • Clinical Site

    Kiel, 24105, Germany

  • Clinical Site

    Langenau, 89129, Germany

  • Clinical Site

    Lübeck, 23538, Germany

  • Clinical Site

    Mahlow, 15831, Germany

  • Clinical Site

    Münster, 48149, Germany

  • Clinical Site

    Wuppertal, 42283, Germany

  • Clinical Site

    Würzburg, 97080, Germany

  • Clinical Site

    Debrecen, 4026, Hungary

  • Clinical Site

    Debrecen, 4032, Hungary

  • Clinical Site

    Pécs, 7632, Hungary

  • Clinical Site

    Catania, 95123, Italy

  • Clinical Site

    Chieti, 66013, Italy

  • Clinical Site

    Cona, 44124, Italy

  • Clinical Site

    Florence, 50122, Italy

  • Clinical Site

    Milan, 20122, Italy

  • Clinical Site

    Modena, 41126, Italy

  • Clinical Site

    Naples, 80131, Italy

  • Clinical Site

    Perugia, 06129, Italy

  • Clinical Site

    Pisa, 56126, Italy

  • Clinical Site

    Roma, 00168, Italy

  • Clinical Site

    Rozzano, 20089, Italy

  • Clinical Site

    Torino, 10126, Italy

  • Clinical Site

    Torrette, 60126, Italy

  • Clinical Site

    Rotterdam, 3015 GD, Netherlands

  • Clinical Site

    Oslo, 0424, Norway

  • Clinical Site

    Bialystok, 15-453, Poland

  • Clinical Site

    Chorzów, 41-516, Poland

  • Clinical Site

    Gdansk, 80-214, Poland

  • Clinical Site

    Katowice, 40-611, Poland

  • Clinical Site

    Kielce, 25-316, 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, 60-539, Poland

  • Clinical Site

    Poznan, 60-848, Poland

  • Clinical Site

    Sosnowiec, 41-200, Poland

  • Clinical Site

    Szczecin, 70-332, Poland

  • Clinical Site

    Szczecin, 71-270, Poland

  • Clinical Site

    Warsaw, 00-710, Poland

  • Clinical Site

    Warsaw, 02-507, Poland

  • Clinical Site

    Warsaw, 02-692, Poland

  • Clinical Site

    Warsaw, 02-953, Poland

  • Clinical Site

    Wroclaw, 50566, 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

    Trnava, 91775, Slovakia

  • Clinical Site

    Alicante, 03010, Spain

  • Clinical Site

    Badalona, 08916, Spain

  • Clinical Site

    Barcelona, 08003, 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, 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

  • Clinical Site

    Leeds, LS9 7TF, United Kingdom

  • Clinical Site

    Salford, M6 8HD, United Kingdom

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