Hidradenitis SuppurativaPhase 2NCT05322473

Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa

A Phase 2 study testing Sonelokimab (M1095) and Adalimumab in people with Hidradenitis Suppurativa, run by MoonLake Immunotherapeutics AG at 57 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. 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 (M1095) and Adalimumab
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 234 participants
Where: 57 sitesin 7 countries
Study dates: 25 Apr 2022to 30 Aug 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Participant is ≥18 years of age;
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;
Participant has a total abscess and/or inflammatory nodule (AN) count of ≥5;
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);
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;
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.

Who cannot join

Participants with known hypersensitivity to sonelokimab or any of its excipients;
Participants with known hypersensitivity to adalimumab or any of its excipients;
Participant has a draining fistula count of ≥20 at the Screening Visit;
Participant has any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of hidradenitis suppurativa;
Prior exposure to more than 2 biologic response modifiers;
Participant has a diagnosis of ulcerative colitis or Crohn's disease.

Trial locations and contacts

57 sites in 7 countries.

Country

City, postcode or hospital

57 sites in 7 countries

United States15 sites

Clinical Site
Bellaire, Texas, 77401
Clinical Site
Beverly, Massachusetts, 01915
Clinical Site
Boston, Massachusetts, 02215
Clinical Site
Charleston, South Carolina, 29425
Clinical Site
Fountain Valley, California, 92708
Clinical Site
Indianapolis, Indiana, 46250
Clinical Site
Los Angeles, California, 90056
Clinical Site
Miami, Florida, 33136
Clinical Site
Nashville, Tennessee, 37215
Clinical Site
New York, New York, 10003
Clinical Site
Omaha, Nebraska, 68144
Clinical Site
Ormond Beach, Florida, 32127
Clinical Site
Philadelphia, Pennsylvania, 19103
Clinical Site
St. Petersburg, Florida, 33709
Clinical Site
Tampa, Florida, 33613

Other trials in United States

Germany14 sites

Clinical Site
Bad Bentheim, 48455
Clinical Site
Berlin, 10117
Clinical Site
Berlin, 10789
Clinical Site
Berlin, 13595
Clinical Site
Bochum, 44791
Clinical Site
Darmstadt, 64283
Clinical Site
Dresden, 01307
Clinical Site
Frankfurt, 60590
Clinical Site
Hamburg, 20246
Clinical Site
Kiel, 24105
Clinical Site
Lübeck, 23538
Clinical Site
Mahlow, 15831
Clinical Site
München, 80337
Clinical Site
Münster, 48149

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Poland11 sites

Clinical Site
Gdansk, 80-214
Clinical Site
Krakow, 31-033
Clinical Site
Lodz, 90-265
Clinical Site
Olsztyn, 10-341
Clinical Site
Ossy, 42-624
Clinical Site
Ostrowiec Świętokrzyski, 27-400
Clinical Site
Poznan, 60-681
Clinical Site
Warsaw, 02-507
Clinical Site
Warsaw, 02-692
Clinical Site
Wroclaw, 50566
Clinical Site
Wroclaw, 51318

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Canada10 sites

Clinical Site
Calgary, Alberta, T3E 0B2
Clinical Site
Fredericton, New Brunswick, E3B 1G9
Clinical Site
Hamilton, Ontario, L8L 3C3
Clinical Site
London, Ontario, N6H 5L5
Clinical Site
Markham, Ontario, L3P 1X2
Clinical Site
Newmarket, Ontario, L3Y 5G8
Clinical Site
Peterborough, Ontario, K9J 5K2
Clinical Site
Saskatoon, Saskatchewan, S7K 2C1
Clinical Site
St. John's, Newfoundland and Labrador, A1A 4Y3
Clinical Site
Winnipeg, Manitoba, R3M 3Z4

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Bulgaria4 sites

Clinical Site
Sofia, 1407
Clinical Site
Sofia, 1431
Clinical Site
Sofia, 1463
Clinical Site
Stara Zagora, 6000

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Netherlands2 sites

Clinical Site
Bergen op Zoom, 4624
Clinical Site
Rotterdam, 3015 GD

Other trials in Netherlands

Ireland1 site

Clinical Site
Dublin, D04 T6F4

Other trials in Ireland

About this study

Official title: Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Moderate to Severe Hidradenitis Suppurativa

Conditions: Hidradenitis Suppurativa
Being tested: Sonelokimab (M1095), Adalimumab, Placebo
Keywords: Hidradenitis Suppurativa, Hidradenitis, Sweat Gland Diseases, Skin Diseases, Skin Diseases, Bacterial, Suppuration, Adalimumab, Anti-Inflammatory Agents, Sonelokimab, Nanobody, Folliculitis, Apocrine Gland Disease, Acne Inversa
Medical subject headings: Hidradenitis Suppurativa, Hidradenitis, Sweat Gland Diseases, Skin Diseases, Skin Diseases, Bacterial, Suppuration, Folliculitis

What participants receive

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

Sonelokimab (M1095)Drug
randomized treatment; parallel-group
AdalimumabDrug
randomized treatment; parallel-group
PlaceboOther
randomized treatment; parallel-group

Study groups in NCT05322473
Study group	Role	What they receive
sonelokimab dose 1 (120 mg)	Experimental	Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period. Receives: Drug: Sonelokimab (M1095)
sonelokimab dose 2 (240 mg)	Experimental	Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period. Receives: Drug: Sonelokimab (M1095)
Placebo	Placebo comparator	Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be re-randomized to receive a sonelokimab dosage regimen during Part B. Receives: Other: Placebo
adalimumab	Active comparator	Subjects randomized to this arm will receive adalimumab during the Double-Blind Treatment Period and will be reallocated to receive sonelokimab dosage regimen during Part B. Receives: Drug: Adalimumab

What is being measured

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

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 12
HiSCR75 was 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. A non-responder imputation (NRI) method was used for missing data.
Measured: At Week 12

Secondary outcomes (4)

Percentage of Participants Achieving HiSCR50 at Week 12
HiSCR50 was defined as at least a 50% reduction from baseline in abscess and AN count, with no increase from baseline in abscess or draining fistula count. An NRI method was used for missing data.
Measured: At Week 12
Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 12
The IHS4 is a validated tool to dynamically assess hidradenitis suppurativa (HS) severity. The IHS4 score was calculated as: number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of ≤3 signified mild, score of 4 to 10 signified moderate, and score of ≥11 signified severe disease. A negative change from baseline indicated an improvement in HS severity.
Measured: Baseline and Week 12
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of ≤5 at Week 12
The DLQI is an instrument designed to assess the impact of the disease on a participant's dermatology-specific quality of life (QoL). The DLQI total score ranged from 0 to 30, with higher scores indicating greater health-related QoL impairment. A negative change from baseline indicated an improvement in health-related QoL. An NRI method was used for missing data.
Measured: At Week 12
Percentage of Participants Achieving a Numerical Rating Scale (NRS) 30 in Patient's Global Assessment (PGA) of Skin Pain at Week 12, in Participants With Baseline NRS ≥3
The PGA of Skin Pain NRS in the past 24 hours was used to assess pain "at its worst" due to HS in the last 24 hours and was completed by the participant using the electronic Diary device. NRS scores ranged from 0 to 10, with higher scores indicating greater skin pain. The weekly averages score was calculated based on the available daily scores from the 7 days on or prior to the nominal day of the visit. The average of the 7 days on or before the date of first dose of trial treatment was used as baseline. A PGA skin pain responder was a participant who achieved NRS30, defined as at least 30% reduction and at least 1-unit reduction from baseline in NRS in PGA skin pain. An NRI method was used for missing data.
Measured: At Week 12

Timeline

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

25 Apr 202230 Aug 2023

First posted11 Apr 2022
Study start25 Apr 2022
Primary completion9 May 2023
Study completion30 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 234 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05322473
Sponsor's protocol ID: M1095-HS-201
Status last verified: May 2024
First submitted: 4 Apr 2022
Last updated: 9 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
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
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)

All Hidradenitis Suppurativa trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Moderate to Severe Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT05322473
Acronym / sponsor ID: M1095-HS-201
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa, Hidradenitis, Sweat Gland Diseases, Skin Diseases, Skin Diseases, Bacterial, Suppuration, Adalimumab, Anti-Inflammatory Agents
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 234 participants (actual)
Lead sponsor: MoonLake Immunotherapeutics AGIndustry (pharma, biotech, devices)
Study start: 25 Apr 2022 (actual)
Primary completion: 9 May 2023 (actual)
Study completion: 30 Aug 2023 (actual)
First posted: 11 Apr 2022 (actual)
Results: Posted 9 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
sonelokimab dose 1 (120 mg)	Experimental	Drug: Sonelokimab (M1095)Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
sonelokimab dose 2 (240 mg)	Experimental	Drug: Sonelokimab (M1095)Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
Placebo	Placebo comparator	Other: PlaceboSubjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be re-randomized to receive a sonelokimab dosage regimen during Part B.
adalimumab	Active comparator	Drug: AdalimumabSubjects randomized to this arm will receive adalimumab during the Double-Blind Treatment Period and will be reallocated to receive sonelokimab dosage regimen during Part B.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Participant is ≥18 years of age;
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;
Participant has a total abscess and/or inflammatory nodule (AN) count of ≥5;
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);
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;

Key exclusion criteria (6 listed)

Participants with known hypersensitivity to sonelokimab or any of its excipients;
Participants with known hypersensitivity to adalimumab or any of its excipients;
Participant has a draining fistula count of ≥20 at the Screening Visit;
Participant has any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of hidradenitis suppurativa;
Prior exposure to more than 2 biologic response modifiers;

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
Sonelokimab (M1095)randomized treatment; parallel-group	Drug	sonelokimab dose 1 (120 mg), sonelokimab dose 2 (240 mg)
Adalimumabrandomized treatment; parallel-group	Drug	adalimumab
Placeborandomized treatment; parallel-group	Other	Placebo

Primary outcome

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 12
Time frame: At Week 12
HiSCR75 was 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. A non-responder imputation (NRI) method was used for missing data.

4 secondary outcomes

Percentage of Participants Achieving HiSCR50 at Week 12
Time frame: At Week 12
Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 12
Time frame: Baseline and Week 12
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of ≤5 at Week 12
Time frame: At Week 12
Percentage of Participants Achieving a Numerical Rating Scale (NRS) 30 in Patient's Global Assessment (PGA) of Skin Pain at Week 12, in Participants With Baseline NRS ≥3
Time frame: At Week 12

Results and safety

Results posted to the registry on 9 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: Placebo	68	64
Part A: Sonelokimab 120 mg	67	66
Part A: Sonelokimab 240 mg	66	64
Part A: Adalimumab	33	32
Part B: Placebo to Sonelokimab 120 mg	0	0
Part B: Placebo to Sonelokimab 240 mg	0	0
Part B: Sonelokimab 120 mg	0	0
Part B: Sonelokimab 240 mg	0	0
Part B: Adalimumab to Sonelokimab 240 mg	0	0

Primary outcome: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 12

Time frame: At Week 12. Number. Unit: percentage of participants

Measure	Part A: Placebo n = 68	Part A: Sonelokimab 120 mg n = 67	Part A: Sonelokimab 240 mg n = 66	Part A: Adalimumab n = 33
Value	14.7	43.3	34.8	36.4

Part A: Placebo vs Part A: Sonelokimab 120 mg: Odds Ratio (OR): 4.823 (95% CI 2.055 to 11.316), p <0.001, Cochran-Mantel-Haenszel
Part A: Placebo vs Part A: Sonelokimab 240 mg: Odds Ratio (OR): 3.133 (95% CI 1.350 to 7.270), p = 0.007, Cochran-Mantel-Haenszel

Population analysed: The FAS included all randomized participants assigned treatment for Part A.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Part A adverse event (AE) reporting: from first dose in Part A until end of Part A (for participants continuing to Part B), or completion of safety follow-up (for participants not continuing to Part B); up to maximum of 19 weeks. Part B AE reporting: from first dose in Part B until completion of safety follow-up; up to maximum of 17 weeks. All-cause mortality: from enrollment until completion of safety follow-up; up to maximum of 23 weeks in Part A or 21 weeks in Part B.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: Placebo	2 of 68 (2.9%)	29 of 68 (42.6%)	0 of 68
Part A: Sonelokimab 120 mg	2 of 67 (3%)	39 of 67 (58.2%)	0 of 67
Part A: Sonelokimab 240 mg	1 of 66 (1.5%)	36 of 66 (54.5%)	0 of 66
Part A: Adalimumab	0 of 33 (0%)	21 of 33 (63.6%)	0 of 33
Part B: Placebo to Sonelokimab 120 mg	0 of 33 (0%)	14 of 33 (42.4%)	0 of 33
Part B: Placebo to Sonelokimab 240 mg	0 of 29 (0%)	17 of 29 (58.6%)	0 of 29
Part B: Sonelokimab 120 mg	0 of 62 (0%)	23 of 62 (37.1%)	0 of 62
Part B: Sonelokimab 240 mg	0 of 64 (0%)	30 of 64 (46.9%)	0 of 64
Part B: Adalimumab to Sonelokimab 240 mg	1 of 32 (3.1%)	12 of 32 (37.5%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hidradenitis Suppurativa

Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
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
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)

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.

MD study director

MoonLake Immunotherapeutics AG

57 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sonelokimab (M1095) and Adalimumab in people with Hidradenitis Suppurativa, run by MoonLake Immunotherapeutics AG at 57 sites in 7 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 6 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Germany, Poland, Canada, Bulgaria and 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 12 (time frame: At Week 12). 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 NCT05322473.

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 9 Sep 2026.