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Hidradenitis SuppurativaPhase 3NCT07007637

A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa

A Phase 3 study testing Sonelokimab in people with Hidradenitis Suppurativa, run by MoonLake Immunotherapeutics AG at 166 sites in 16 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

This is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who were previously enrolled in a parental study. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Hidradenitis Suppurativa
What is being tested?
Sonelokimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
835 participants
Where
166 sitesin 16 countries
Study dates
27 Jun 2025to 13 Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

166 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

166 sites in 16 countries

United States49 sites

  • Clinical Site

    Ann Arbor, Michigan, 48109-5314

  • Clinical Site

    Aventura, Florida, 33180

  • Clinical Site

    Birmingham, Alabama, 35244

  • Clinical Site

    Boardman, Ohio, 44512

  • Clinical Site

    Boston, Massachusetts, 02116

  • Clinical Site

    Boston, Massachusetts, 02215

  • Clinical Site

    Canton, Michigan, 48187

  • Clinical Site

    Clarkston, Michigan, 48346

  • Clinical Site

    Columbus, Indiana, 47201

  • Clinical Site

    Columbus, Ohio, 43213

  • Clinical Site

    Coral Gables, Florida, 33134

  • Clinical Site

    Dallas, Texas, 75235

  • Clinical Site

    Dallas, Texas, 75246

  • Clinical Site

    Dayton, Ohio, 45324

  • Clinical Site

    Fargo, North Dakota, 58103

  • Clinical Site

    Hialeah, Florida, 33012

  • Clinical Site

    Hollywood, Florida, 33021-6746

  • Clinical Site

    Houston, Texas, 77004

  • Clinical Site

    Las Vegas, Nevada, 89148

  • Clinical Site

    Los Angeles, California, 90404

  • Clinical Site

    Louisville, Kentucky, 40241

  • Clinical Site

    Macon, Georgia, 31217

  • Clinical Site

    Metairie, Louisiana, 70006

  • Clinical Site

    Miami, Florida, 33136

  • Clinical Site

    Miami, Florida, 33163

  • Clinical Site

    Mill Creek, Washington, 98012

  • Clinical Site

    Morgantown, West Virginia, 26505

  • Clinical Site

    Murfreesboro, Tennessee, 37130

  • Clinical Site

    Murray, Kentucky, 42071

  • Clinical Site

    New Albany, Indiana, 47150

  • Clinical Site

    New Brighton, Minnesota, 55112

  • Clinical Site

    New York, New York, 10003

  • Clinical Site

    New York, New York, 10012

  • Clinical Site

    North Little Rock, Arkansas, 72117

  • Clinical Site

    Northridge, California, 91325

  • Clinical Site

    Ocala, Florida, 34471

  • Clinical Site

    Oklahoma City, Oklahoma, 73118

  • Clinical Site

    Omaha, Nebraska, 68144

  • Clinical Site

    Plainfield, Indiana, 46168

  • Clinical Site

    San Antonio, Texas, 78213

  • Clinical Site

    San Antonio, Texas, 78218

  • Clinical Site

    Sandy Springs, Georgia, 30328

  • Clinical Site

    Skokie, Illinois, 60077

  • Clinical Site

    South Jordan, Utah, 84095

  • Clinical Site

    Tampa, Florida, 33607

  • Clinical Site

    Tampa, Florida, 33613

  • Clinical Site

    The Bronx, New York, 10467

  • Clinical Site

    Waterford, Michigan, 48328

  • Clinical Site

    West Dundee, Illinois, 60118

Other trials in United States

Poland22 sites

  • Clinical Site

    Bialystok, 15-453

  • Clinical Site

    Chorzów, 41-516

  • Clinical Site

    Gdansk, 80-214

  • Clinical Site

    Katowice, 40-611

  • Clinical Site

    Kielce, 25-316

  • Clinical Site

    Krakow, 30-002

  • Clinical Site

    Krakow, 30-727

  • Clinical Site

    Lodz, 90-265

  • Clinical Site

    Lodz, 90-436

  • Clinical Site

    Lublin, 20-573

  • Clinical Site

    Ossy, 42-624

  • Clinical Site

    Poznan, 60-539

  • Clinical Site

    Poznan, 60-848

  • Clinical Site

    Sosnowiec, 41-200

  • Clinical Site

    Szczecin, 70-332

  • Clinical Site

    Szczecin, 71-270

  • Clinical Site

    Warsaw, 00-710

  • Clinical Site

    Warsaw, 02-507

  • Clinical Site

    Warsaw, 02-692

  • Clinical Site

    Warsaw, 02-953

  • Clinical Site

    Wroclaw, 50566

  • Clinical Site

    Wroclaw, 51-503

Other trials in Poland

Germany21 sites

  • Clinical Site

    Augsburg, 86179

  • Clinical Site

    Bad Bentheim, 48455

  • Clinical Site

    Berlin, 10117

  • Clinical Site

    Berlin, 10789

  • Clinical Site

    Bielefeld, 33647

  • Clinical Site

    Bochum, 44791

  • Clinical Site

    Bochum, 44793

  • Clinical Site

    Bramsche, 49565

  • Clinical Site

    Darmstadt, 64283

  • Clinical Site

    Dresden, 01307

  • Clinical Site

    Erlangen, 91054

  • Clinical Site

    Frankfurt, 60590

  • Clinical Site

    Halle, Saale, 06108

  • Clinical Site

    Hanover, 30159

  • Clinical Site

    Kiel, 24105

  • Clinical Site

    Langenau, 89129

  • Clinical Site

    Lübeck, 23538

  • Clinical Site

    Mahlow, 15831

  • Clinical Site

    Münster, 48149

  • Clinical Site

    Wuppertal, 42283

  • Clinical Site

    Würzburg, 97080

Other trials in Germany

Canada18 sites

  • Clinical Site

    Barrie, Ontario, L4M 7G1

  • Clinical Site

    Calgary, Alberta, T3E 0B2

  • Clinical Site

    Edmonton, Alberta, T6G 1C3

  • Clinical Site

    Edmonton, Alberta, T6H 4J8

  • Clinical Site

    Fredericton, New Brunswick, E3B 1G9

  • Clinical Site

    Guelph, Ontario, N0B 2J0

  • Clinical Site

    London, Ontario, N6H 5L5

  • Clinical Site

    Markham, Ontario, L3P 1X3

  • Clinical Site

    Montreal, Quebec, H1Y 3L1

  • Clinical Site

    Newmarket, Ontario, L3Y 5G8

  • Clinical Site

    Peterborough, Ontario, K9J 5K2

  • Clinical Site

    Québec, Quebec, G1W 4R4

  • Clinical Site

    Saskatoon, Saskatchewan, S7K 2C1

  • Clinical Site

    Sherwood Park, Alberta, T8H 0P1

  • Clinical Site

    Toronto, Ontario, M2N 3A6

  • Clinical Site

    Toronto, Ontario, M4E 1R7

  • Clinical Site

    Toronto, Ontario, M5A3R6

  • Clinical Site

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Spain17 sites

  • Clinical Site

    Alicante, 03010

  • Clinical Site

    Badalona, 08916

  • Clinical Site

    Barcelona, 08003

  • Clinical Site

    Cadiz, 11009

  • Clinical Site

    Córdoba, 14004

  • Clinical Site

    Granada, 18012

  • Clinical Site

    Granada, 18014

  • Clinical Site

    Granollers, 08402

  • Clinical Site

    Madrid, 28006

  • Clinical Site

    Madrid, 28041

  • Clinical Site

    Madrid, 28046

  • Clinical Site

    Málaga, 29010

  • Clinical Site

    Manises, 46940

  • Clinical Site

    Santiago de Compostela, 15706

  • Clinical Site

    Seville, 41009

  • Clinical Site

    Valencia, 46014

  • Clinical Site

    Valencia, 46026

Other trials in Spain

Italy13 sites

  • Clinical Site

    Catania, 95123

  • Clinical Site

    Chieti, 66013

  • Clinical Site

    Cona, 44124

  • Clinical Site

    Florence, 50122

  • Clinical Site

    Milan, 20122

  • Clinical Site

    Modena, 41126

  • Clinical Site

    Naples, 80131

  • Clinical Site

    Perugia, 06129

  • Clinical Site

    Pisa, 56126

  • Clinical Site

    Roma, 00168

  • Clinical Site

    Rozzano, 20089

  • Clinical Site

    Torino, 10126

  • Clinical Site

    Torrette, 60126

Other trials in Italy

Bulgaria7 sites

  • Clinical Site

    Pleven, Ontario, 5800

  • Clinical Site

    Sofia, Ontario, 1463

  • Clinical Site

    Sofia, 1407

  • Clinical Site

    Sofia, 1431

  • Clinical Site

    Sofia, 1510

  • Clinical Site

    Sofia, 1606

  • Clinical Site

    Stara Zagora, Ontario, 6003

Other trials in Bulgaria

France4 sites

  • Clinical Site

    Brest, 29200

  • Clinical Site

    Lyon, 69003

  • Clinical Site

    Saint-Mandé, 94160

  • Clinical Site

    Saint-Priest-en-Jarez, 42270

Other trials in France

Hungary3 sites

  • Clinical Site

    Debrecen, 4026

  • Clinical Site

    Debrecen, 4032

  • Clinical Site

    Pécs, 7632

Other trials in Hungary

Portugal3 sites

  • Clinical Site

    Lisbon, 1169-050

  • Clinical Site

    Lisbon, 1649-035

  • Clinical Site

    Porto, 4050-342

Other trials in Portugal

Belgium2 sites

  • Clinical Site

    Ghent, 9000

  • Clinical Site

    Leuven, 3000

Other trials in Belgium

Czechia2 sites

  • Clinical Site

    Ostrava, 708 52

  • Clinical Site

    Prague, 110 00

Other trials in Czechia

United Kingdom2 sites

  • Clinical Site

    Leeds, LS9 7TF

  • Clinical Site

    Salford, M6 8HD

Other trials in United Kingdom

Netherlands1 site

  • Clinical Site

    Rotterdam, 3015 GD

Other trials in Netherlands

Norway1 site

  • Clinical Site

    Oslo, 0424

Other trials in Norway

Slovakia1 site

  • Clinical Site

    Trnava, 91775

Other trials in Slovakia

About this study

Official title: A Phase 3, Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa

This is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who were previously enrolled in a parental study.

Being tested
Sonelokimab
Keywords
Hidradenitis Suppurativa, Hidradenitis, Sweat Gland Diseases, Skin Diseases, Skin Diseases, Bacterial, Suppuration, Anti-Inflammatory Agents, Sonelokimab, Nanobody, Apocrine Gland Disease
Medical subject headings
Hidradenitis Suppurativa, Hidradenitis, Sweat Gland Diseases, Skin Diseases, Skin Diseases, Bacterial, Suppuration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SonelokimabDrug

    Sonelokimab

Study groups in NCT07007637
Study groupRoleWhat they receive
Experimental: sonelokimabExperimentalAll participants will receive sonelokimab 120 mg Q4W for up to 2 years
Receives: Drug: Sonelokimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab

    Incidence, relatedness, severity and seriousness of all AEs

    Measured: 2.5-3 years

  2. Long-term safety and tolerability of sonelokimab: Treatment emergent adverse events (TEAEs)

    Incidence, relatedness, severity and seriousness of all TEAEs

    Measured: 2.5-3 years

  3. Long-term safety and tolerability of sonelokimab: Adverse events of special interest (AESIs)

    Incidence, relatedness, severity and seriousness of all AESIs

    Measured: 2.5-3 years

  4. Long-term safety and tolerability of sonelokimab: Discontinuation of sonelokimab treatment due to AEs

    Number of participants discontinued from sonelokimab treatment due to AEs

    Measured: 2.5-3 years

  5. Long-term safety and tolerability of sonelokimab: Clinically significant changes in clinical laboratory parameters

    Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline

    Measured: 2.5-3 years

  6. Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram

    Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline

    Measured: 2.5-3 years

Secondary outcomes (6)

  1. Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

    Percentage of participants achieving a HiSCR75 response over time

    Measured: 2.5 - 3 years

  2. Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) and 50 (HiSCR50)

    Percentage of participants achieving a HiSCR90 and HiSCAR50 response over time

    Measured: 2.5 - 3 years

  3. Long-term efficacy of sonelokimab: International Hidradenitis Suppurativa Severity Score System (IHS4)

    Absolute change in IHS4 score over time

    Measured: 2.5 - 3 years

  4. Long-term efficacy of sonelokimab: Number of abscesses, draining fistulas/tunnels; inflammatory nodules

    Absolute change in number of abscesses, draining fistulas/tunnels; inflammatory nodules

    Measured: 2.5 - 3 years

  5. Long-term efficacy of sonelokimab: Dermatology Life Quality Index (DLQI)

    Change in DLQI total score

    Measured: 2.5 - 3 years

  6. Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Quality of Life (HiSQOL)

    Change in HiSQOL total score

    Measured: 2.5 - 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2025
  2. Study start27 Jun 2025
  3. Primary completion13 Jun 2028 (estimated)
  4. Study completion13 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
835 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07007637
Sponsor's protocol ID
M1095-HS-303
Other IDs
VELA-OLE
Status last verified
Jun 2026
First submitted
28 May 2025
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sonelokimab in people with Hidradenitis Suppurativa, run by MoonLake Immunotherapeutics AG at 166 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in United States, Poland, Germany, Canada, Spain and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab (time frame: 2.5-3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07007637.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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