Hidradenitis SuppurativaPhase 3NCT06411379
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 106 sites in 12 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
- 418 participants
- Where
- 106 sitesin 12 countries
- Study dates
- 14 May 2024to 20 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
106 sites in 12 countries.
106 sites in 12 countries
United States30 sites
Clinical Site
Ann Arbor, Michigan, 48109-5314
Clinical Site
Aventura, Florida, 33180
Clinical Site
Baltimore, Maryland, 21287
Clinical Site
Baton Rouge, Louisiana, 70809
Clinical Site
Birmingham, Alabama, 35244
Clinical Site
Canton, Michigan, 48187
Clinical Site
Clarkston, Michigan, 48346
Clinical Site
Columbus, Ohio, 43213
Clinical Site
Dallas, Texas, 75390-8565
Clinical Site
Fargo, North Dakota, 58103
Clinical Site
Fountain Valley, California, 92708
Clinical Site
Hialeah, Florida, 33012
Clinical Site
Las Vegas, Nevada, 89145
Clinical Site
Miami, Florida, 33136
Clinical Site
Milwaukee, Wisconsin, 53226
Clinical Site
Morgantown, West Virginia, 26505
Clinical Site
Murfreesboro, Tennessee, 37130
Clinical Site
Murray, Kentucky, 42071
Clinical Site
New Brighton, Minnesota, 55112
Clinical Site
New York, New York, 10003
Clinical Site
North Little Rock, Arkansas, 72117
Clinical Site
Ocala, Florida, 34470
Clinical Site
Omaha, Nebraska, 68144
Clinical Site
Plainfield, Indiana, 46168
Clinical Site
Plano, Texas, 75025
Clinical Site
San Antonio, Texas, 78213
Clinical Site
Santa Monica, California, 90404
Clinical Site
Skokie, Illinois, 60077
Clinical Site
Tampa, Florida, 33613
Clinical Site
Waterford, Michigan, 48328
Spain21 sites
Clinical Site
Alcorcón, 28922
Clinical Site
Alicante, 03010
Clinical Site
Badalona, 08916
Clinical Site
Barcelona, 08003
Clinical Site
Barcelona, 08036
Clinical Site
Barcelona, 08041
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, 28007
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
Germany13 sites
Clinical Site
Augsburg, 86179
Clinical Site
Bad Bentheim, 48455
Clinical Site
Berlin, 10117
Clinical Site
Bielefeld, 33647
Clinical Site
Bochum, 44791
Clinical Site
Bramsche, 49565
Clinical Site
Darmstadt, 64283
Clinical Site
Dresden, 01307
Clinical Site
Gera, 07548
Clinical Site
Hamburg, 20246
Clinical Site
Kiel, 24105
Clinical Site
Lübeck, 23538
Clinical Site
Würzburg, 97080
France11 sites
Clinical Site
Antony, 92160
Clinical Site
Besançon, 25030
Clinical SIte
Brest, 29200
Clinical Site
Dijon, 21000
Clinical Site
Le Mans, 72037
Clinical Site
Lyon, 69003
Clinical Site
Montpellier, 34295
Clinical Site
Rouen, 76031
Clinical Site
Saint-Mandé, 94160
Clinical Site
Saint-Priest-en-Jarez, 42270
Clinical Site
Toulouse, 31400
Canada8 sites
Clinical Site
Calgary, Alberta, T3E 0B2
Clinical Site
Edmonton, Alberta, T6G 1C3
Clinical Site
Guelph, Ontario, N1L 0B7
Clinical Site
Peterborough, Ontario, K9J 5K2
Clinical Site
Richmond Hill, Ontario, L4B 1A5
Clinical Site
Saskatoon, Saskatchewan, S7K 2C1
Clinical Site
Toronto, Ontario, M4E 1R7
Clinical Site
Windsor, Ontario, N8W 1E6
Poland8 sites
Clinical Site
Chorzów, 41-500
Clinical Site
Katowice, 40-611
Clinical Site
Kielce, 25-316
Clinical Site
Olsztyn, 10-229
Clinical Site
Poznan, 61-731
Clinical Site
Szczecin, 70-332
Clinical Site
Warsaw, 02-953
Clinical Site
Wroclaw, 50566
Bulgaria5 sites
Clinical Site
Sofia, 1431
Clinical Site
Sofia, 1463
Clinical Site
Sofia, 1510
Clinical Site
Sofia, 1606
Clinical Site
Stara Zagora, 6003
Belgium4 sites
Clinical Site
Ghent, 9000
Clinical Site
Leuven, 3000
Clinical Site
Liège, 4000
Clinical Site
Woluwe-Saint-Lambert, 1200
Czechia3 sites
Clinical Site
Ostrava, 708 52
Clinical Site
Prague, 110 00
Clinical Site
Prague, 15006
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 & NRS50) 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 start14 May 2024
- Primary completion14 Aug 2025
- Study completion20 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
- 418 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
- NCT06411379
- Sponsor's protocol ID
- M1095-HS-302
- Other IDs
- VELA-2
- Status last verified
- May 2026
- First submitted
- 8 May 2024
- Last updated
- 8 Jun 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 8 Jun 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
- NCT06411379
- Acronym / sponsor ID
- M1095-HS-302
- 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
- 418 participants (actual)
- Lead sponsor
- MoonLake Immunotherapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 14 May 2024 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 20 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 & NRS50) 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 8 Jun 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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A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
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Acceptability of MBSR for People With HS
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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
106 sites in 12 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 106 sites in 12 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 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 106 sites in United States, Spain, Germany, France, Canada and 7 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 8 Jun 2026.