Hidradenitis SuppurativaPhase 3NCT06411899
A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
A Phase 3 study testing Sonelokimab in people with Hidradenitis Suppurativa, run by MoonLake Immunotherapeutics AG at 109 sites in 10 countries.
Trial summary
This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Sonelokimab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 422 participants
- Where
- 109 sitesin 10 countries
- Study dates
- 15 May 2024to 14 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be at least 18 years of age at the time of signing the informed consent.
- 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.
- 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.
- Participants who have a total AN count of ≥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).
Who cannot join
- Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
- Participants with underlying conditions that, in the opinion of the investigator, potentially places the participant at unacceptable risk.
- 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.
- 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.
- Participants with a gastrointestinal condition including inflammatory bowel disease or diagnosis of ulcerative colitis or Crohn's disease.
Trial locations and contacts
109 sites in 10 countries.
109 sites in 10 countries
United States36 sites
Clinical Site
Boardman, Ohio, 44512
Clinical Site
Boston, Massachusetts, 02116
Clinical Site
Boston, Massachusetts, 02215
Clinical Site
Charleston, South Carolina, 29425
Clinical Site
Columbus, Indiana, 47201
Clinical Site
Coral Gables, Florida, 33134
Clinical Site
Coral Springs, Florida, 33071
Clinical Site
Dayton, Ohio, 45324
Clinical Site
Dearborn, Michigan, 48126
Clinical Site
Forest, Virginia, 24551
Clinical Site
Frisco, Texas, 75034
Clinical Site
Hollywood, Florida, 33201
Clinical Site
Houston, Texas, 77004
Clinical Site
Houston, Texas, 77082
Clinical Site
Las Vegas, Nevada, 89119
Clinical Site
Los Angeles, California, 90024
Clinical Site
Louisville, Kentucky, 40241
Clinical Site
Macon, Georgia, 31217
Clinical Site
Margate, Florida, 33063
Clinical Site
Mayfield Heights, Ohio, 44124
Clinical Site
Metairie, Louisiana, 70006
Clinical Site
Miami, Florida, 33161
Clinical Site
Mill Creek, Washington, 98012
Clinical Site
Nashville, Tennessee, 37215
Clinical Site
New Albany, Indiana, 47150
Clinical Site
New York, New York, 10012
Clinical Site
Northridge, California, 91325
Clinical Site
Oklahoma City, Oklahoma, 73118
Clinical Site
Sacramento, California, 95815
Clinical Site
San Diego, California, 92123
Clinical Site
Sandy Springs, Georgia, 30328
Clinical Site
South Jordan, Utah, 84095
Clinical Site
Tampa, Florida, 33607
Clinical Site
The Bronx, New York, 10467
Clinical Site
Warren, Michigan, 48088
Clinical Site
West Dundee, Illinois, 60118
Poland15 sites
Clinical Site
Bialystok, 15-453
Clinical Site
Gdansk, 80-214
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, 60-529
Clinical Site
Sosnowiec, 41-200
Clinical Site
Szczecin, 71-500
Clinical Site
Warsaw, 00-710
Clinical Site
Warsaw, 02-507
Clinical Site
Warsaw, 02-692
Clinical Site
Wroclaw, 51-503
Canada14 sites
Clinical Site
Barrie, Ontario, L4M 7G1
Clinical Site
Edmonton, Alberta, T5J 3S9
Clinical Site
Edmonton, Alberta, T6H 4J8
Clinical Site
Fredericton, New Brunswick, E3B 1G9
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
Québec, Quebec, G1W 4R4
Clinical Site
Sherbrooke, Quebec, J1G 1X9
Clinical Site
Sherwood Park, Alberta, T8H 0P1
Clinical Site
Toronto, Ontario, M2N 3A6
Clinical Site
Toronto, Ontario, M5A3R6
Clinical Site
Winnipeg, Manitoba, R3M 3Z4
Germany14 sites
Clinical Site
Berlin, 10789
Clinical Site
Bochum, 44805
Clinical Site
Buxtehude, 21614
Clinical Site
Erlangen, 91054
Clinical Site
Essen, 45147
Clinical Site
Frankfurt, 60590
Clinical SIte
Halle, 06108
Clinical Site
Hanover, 30159
Clinical Site
Langenau, 89129
Clinical Site
Mahlow, 15831
Clinical Site
München, 80337
Clinical Site
Münster, 48149
Clinical Site
Oldenburg, 26133
Clinical Site
Wuppertal, 42283
Italy14 sites
Clinical Site
Brescia, 25123
Clinical Site
Catania, 95123
Clinical Site
Chieti, 66100
Clinical Site
Cona, 44124
Clinical Site
Florence, 50125
Clinical Site
Milan, 20122
Clinical Site
Modena, 41124
Clinical Site
Naples, 80131
Clinical Site
Perugia, 06129
Clinical Site
Pisa, 56126
Clinical Site
Rome, 00168
Clinical Site
Rozzano, 20089
Clinical Site
Torino, 10126
Clinical Site
Torrette, 60020
Bulgaria4 sites
Clinical SIte
Pleven, 5800
Clinical Site
Sofia, 1407
Clinical Site
Sofia, 1527
Clinical Site
Sofia, 1606
Hungary4 sites
Clinical Site
Budapest, 1036
Clinical Site
Debrecen, 4031
Clinical Site
Debrecen, 4032
Clinical Site
Pécs, 7632
United Kingdom4 sites
Clinical Site
Cardiff, CF14 4XW
Clinical Site
Dudley, DY1 2HQ
Clinical Site
Leeds, LS9 7TF
Clinical Site
Salford, M6 8HD
Portugal3 sites
Clinical Site
Lisbon, 1169-050
Clinical Site
Lisbon, 1649-035
Clinical Site
Porto, 4050-342
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Sonelokimab, Placebo
- 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
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| sonelokimab | Experimental | Subjects randomized to this arm will receive sonelokimab 120 mg Q2W from Weeks 0 to 6 then 120 mg Q4W starting at Week 8 up to Week 48. Receives: Drug: Sonelokimab |
| Placebo | Placebo comparator | Subjects randomized to this arm will receive placebo Q2W from Weeks 0 to 6 then Q4W starting at Week 8 up to Week 16. They will receive sonelokimab 120 mg Q2W for 4 doses from Weeks 16 to 22 then Q4W from Week 24 up to Week 48 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hidradenitis Suppurativa Clinical Response 75
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) where HiSCR75 is defined as at least a 75% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count.
Measured: Week 16
Secondary outcomes (6)
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Percentage of participants achieving HiSCR50
Measured: Week 16
Change in International Hidradenitis Suppurativa Severity Score System
Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)
The IHS4 score is calculated as follows: number of nodules (multiplied by 1) + number of abscesses (multiplied by 2) + number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.
Measured: Week 16
Dermatology Life Quality Index (DLQI)
Percentage of participants achieving a DLQI total reduction of ≥4 minimal clinically important difference among participants with a baseline DLQI ≥4. DLQI produces a numeric score that can range from 0 to 30. A higher score indicates greater health related quality of life impairment.
Measured: Week 16
Reduction from Numerical Rating Scale (NRS30 & NR550) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)
Percentage of participants achieving at least ≥30% (and ≥50%) reduction and at least 2-unit reduction from Baseline in Numerical Rating Scale (NRS30 \& NRS50) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3
Measured: Week 16
Patient Global Impression-Severity of Illness-Hidradenitis Suppurativa at Week 16
Percentage of participants with minimal or absent symptoms using the Patient Global Impression - Severity of Illness - Hidradenitis Suppurativa at Week 16. Participants choose the response that best describes the severity of their disease. The question is rated on a 7-point scale ranging from 0 to 6 (0=absent; 1=minimal; 2=mild; 3=moderate; 4=moderately severe; 5=severe; 6=very severe).
Measured: Week 16
Resolution of draining tunnels (DT100)
Percentage of participants with zero draining tunnels in the subgroup of participants with at least one draining tunnel at baseline (DT100)
Measured: Week 16 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start15 May 2024
- Primary completion2 Sep 2025
- Study completion14 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- MoonLake Immunotherapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof Kristian Reich, M.D., Ph.D. (equ.), Study director, MoonLake Immunotherapeutics AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411899
- Sponsor's protocol ID
- M1095-HS-301
- Other IDs
- VELA-1
- Status last verified
- May 2026
- First submitted
- 8 May 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT06411899
- Acronym / sponsor ID
- M1095-HS-301
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, Hidradenitis, Sweat Gland Diseases, Skin Diseases, Skin Diseases, Bacterial, Suppuration, Anti-Inflammatory Agents, Sonelokimab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- MoonLake Immunotherapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 15 May 2024 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- 14 May 2026 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sonelokimab | Experimental | Drug: SonelokimabSubjects randomized to this arm will receive sonelokimab 120 mg Q2W from Weeks 0 to 6 then 120 mg Q4W starting at Week 8 up to Week 48. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects randomized to this arm will receive placebo Q2W from Weeks 0 to 6 then Q4W starting at Week 8 up to Week 16. They will receive sonelokimab 120 mg Q2W for 4 doses from Weeks 16 to 22 then Q4W from Week 24 up to Week 48 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be at least 18 years of age at the time of signing the informed consent.
- 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.
- 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.
- Participants who have a total AN count of ≥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).
Key exclusion criteria (6 listed)
- Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
- Participants with underlying conditions that, in the opinion of the investigator, potentially places the participant at unacceptable risk.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonelokimabSonelokimab | Drug | sonelokimab |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Hidradenitis Suppurativa Clinical Response 75
Time frame: Week 16
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) where HiSCR75 is defined as at least a 75% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count.
6 secondary outcomes
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Time frame: Week 16
Change in International Hidradenitis Suppurativa Severity Score System
Time frame: Week 16
Dermatology Life Quality Index (DLQI)
Time frame: Week 16
Reduction from Numerical Rating Scale (NRS30 & NR550) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)
Time frame: Week 16
Patient Global Impression-Severity of Illness-Hidradenitis Suppurativa at Week 16
Time frame: Week 16
Resolution of draining tunnels (DT100)
Time frame: Week 16 and Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
Related trials for Hidradenitis Suppurativa
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Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
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Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
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ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Kristian Reich, M.D., Ph.D. (equ.) study director
MoonLake Immunotherapeutics AG
109 sites in 10 countries: see every site and its status.
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 109 sites in 10 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 109 sites in United States, Poland, Canada, Germany, Italy and 5 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hidradenitis Suppurativa Clinical Response 75 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.