CompletedNCT05322473Updated Sep 9, 2026Results posted

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

A Phase 2 interventional study of Sonelokimab (M1095) and Adalimumab in Hidradenitis Suppurativa, sponsored by MoonLake Immunotherapeutics AG. Completed at 57 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by MoonLake Immunotherapeutics AG · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 234
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Hidradenitis Suppurativa

Browse trials for

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

In context

Hidradenitis Suppurativa

284 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.

This study's enrollment of 234 is above the median of 45 across 199 interventional studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

MoonLake Immunotherapeutics AG is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 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.

Exclusion criteria

Exclusion Criteria:

Participants with known to sonelokimab or any of its ;
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.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication: A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hypersensitivity: An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Excipients: The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 234 participants (actual)

Study arms

Experimental
sonelokimab dose 1 (120 mg)
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.
Drug: Sonelokimab (M1095)
Experimental
sonelokimab dose 2 (240 mg)
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.
Drug: Sonelokimab (M1095)
Placebo comparator
Placebo
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.
Other: Placebo
Active comparator
adalimumab
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.
Drug: Adalimumab

Interventions

DrugSonelokimab (M1095)
randomized treatment; parallel-group
DrugAdalimumab
randomized treatment; parallel-group
OtherPlacebo
randomized treatment; parallel-group

What researchers measure

Primary outcomes

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.
Time frame: At Week 12

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: At Week 12

Results

Posted Sep 9, 2026

Participant flow

Participants were enrolled in 7 countries in Europe and North America. The trial included a screening period of up to 4 weeks, a 12-week placebo-controlled treatment period (Part A), a 12-week active treatment period (Part B), and safety follow-up period of 4 weeks (with safety follow-up visit occurring 8 weeks \[± 7 days\] after the last dose of trial treatment).

Part A

Participant flow — Part A
Milestone	Part A: Placebo	Part A: Sonelokimab 120 mg	Part A: Sonelokimab 240 mg	Part A: Adalimumab
Started	68	67	66	33
Completed	64	66	64	32
Not completed	4	1	2	1
Withdrew: Adverse event	1	0	0	0
Withdrew: Lost to follow-up	1	1	1	0
Withdrew: Withdrawal by subject	2	0	1	0
Withdrew: Protocol violation	0	0	0	1

Part B

Participant flow — Part B
Milestone	Part B: Placebo to Sonelokimab 120 mg	Part B: Placebo to Sonelokimab 240 mg	Part B: Sonelokimab 120 mg	Part B: Sonelokimab 240 mg	Part B: Adalimumab to Sonelokimab 240 mg
Started	33	29	62	64	32
Completed	32	28	58	60	29
Not completed	1	1	4	4	3
Withdrew: Adverse event	1	0	1	0	0
Withdrew: Lost to follow-up	0	0	3	3	3
Withdrew: Withdrawal by subject	0	1	0	1	0

Outcome measures

PrimaryPercentage 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.

Time frame:: At Week 12
Reported as:: Number · percentage of participants

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 12
percentage of participants	Part A: Placebo	Part A: Sonelokimab 120 mg	Part A: Sonelokimab 240 mg	Part A: Adalimumab
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 12	14.7	43.3	34.8	36.4

Statistical analysis

Part A: Placebo vs Part A: Sonelokimab 120 mg · Cochran-Mantel-Haenszel · p = <0.001 · Odds ratio (or): 4.823 · 95% CI 2.055 to 11.316The Cochran-Mantel-Haenszel (CMH) test was stratified by Hurley Stage status (II and III) and prior biologic use (yes and no) at baseline.
Part A: Placebo vs Part A: Sonelokimab 240 mg · Cochran-Mantel-Haenszel · p = 0.007 · Odds ratio (or): 3.133 · 95% CI 1.350 to 7.270The CMH test was stratified by Hurley Stage status (II and III) and prior biologic use (yes and no) at baseline.

SecondaryPercentage 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.

Time frame:: At Week 12
Reported as:: Number · percentage of participants

Percentage of Participants Achieving HiSCR50 at Week 12
percentage of participants	Part A: Placebo	Part A: Sonelokimab 120 mg	Part A: Sonelokimab 240 mg	Part A: Adalimumab
Percentage of Participants Achieving HiSCR50 at Week 12	27.9	65.7	53.0	57.6

Statistical analysis

Part A: Placebo vs Part A: Sonelokimab 120 mg · Cochran-Mantel-Haenszel · p = <0.001 · Odds ratio (or): 4.998 · 95% CI 2.389 to 10.455The CMH test was stratified by Hurley Stage status (II and III) and prior biologic use (yes and no) at baseline.
Part A: Placebo vs Part A: Sonelokimab 240 mg · Cochran-Mantel-Haenszel · p = 0.003 · Odds ratio (or): 2.907 · 95% CI 1.419 to 5.956The CMH test was stratified by Hurley Stage status (II and III) and prior biologic use (yes and no) at baseline.

SecondaryChange 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.

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · score on a scale

Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 12
score on a scale	Part A: Placebo	Part A: Sonelokimab 120 mg	Part A: Sonelokimab 240 mg	Part A: Adalimumab
Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 12	-7.91 ± 2.11	-19.32 ± 2.10	-14.55 ± 2.10	-15.46 ± 2.97

Statistical analysis

Part A: Placebo vs Part A: Sonelokimab 120 mg · Mixed Model Repeated Measures · p = <0.001 · Least square mean difference: -11.42 · 95% CI -17.00 to -5.83Fixed effects: treatment, visit, Hurley Stage status, prior biologic use, baseline measurements, visit-by-treatment; random effect: participant.
Part A: Placebo vs Part A: Sonelokimab 240 mg · Mixed Model Repeated Measures · p = 0.020 · Least square mean difference: -6.64 · 95% CI -12.24 to -1.04Fixed effects: treatment, visit, Hurley Stage status, prior biologic use, baseline measurements, visit-by-treatment; random effect: participant.

SecondaryPercentage 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.

Time frame:: At Week 12
Reported as:: Number · percentage of participants

Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of ≤5 at Week 12
percentage of participants	Part A: Placebo	Part A: Sonelokimab 120 mg	Part A: Sonelokimab 240 mg	Part A: Adalimumab
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of ≤5 at Week 12	21.6	26.8	33.9	28.0

Statistical analysis

Part A: Placebo vs Part A: Sonelokimab 120 mg · Cochran-Mantel-Haenszel · p = 0.510 · Odds ratio (or): 1.347 · 95% CI 0.551 to 3.294The CMH test was stratified by Hurley Stage status (II and III) and prior biologic use (yes and no) at baseline.
Part A: Placebo vs Part A: Sonelokimab 240 mg · Cochran-Mantel-Haenszel · p = 0.169 · Odds ratio (or): 1.845 · 95% CI 0.774 to 4.396The CMH test was stratified by Hurley Stage status (II and III) and prior biologic use (yes and no) at baseline.

SecondaryPercentage 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.

Time frame:: At Week 12
Reported as:: Number · percentage of participants

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
percentage of participants	Part A: Placebo	Part A: Sonelokimab 120 mg	Part A: Sonelokimab 240 mg	Part A: Adalimumab
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	17.0	40.0	54.3	57.1

Statistical analysis

Part A: Placebo vs Part A: Sonelokimab 120 mg · Cochran-Mantel-Haenszel · p = 0.008 (Nominal p-value) · Odds ratio (or): 3.882 · 95% CI 1.407 to 10.709The CMH test was stratified by Hurley Stage status (II and III) and prior biologic use (yes and no) at baseline.
Part A: Placebo vs Part A: Sonelokimab 240 mg · Cochran-Mantel-Haenszel · p = <0.001 (Nominal p-value) · Odds ratio (or): 5.617 · 95% CI 2.142 to 14.730The CMH test was stratified by Hurley Stage status (II and III) and prior biologic use (yes and no) at baseline.

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

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

Most frequent serious events

Most frequent serious events
Event	Part A: Placebo	Part A: Sonelokimab 120 mg	Part A: Sonelokimab 240 mg	Part A: Adalimumab	Part B: Placebo to Sonelokimab 120 mg	Part B: Placebo to Sonelokimab 240 mg	Part B: Sonelokimab 120 mg	Part B: Sonelokimab 240 mg	Part B: Adalimumab to Sonelokimab 240 mg
Abortion spontaneousPregnancy, puerperium and perinatal conditions	0/68	0/67	0/66	0/33	0/33	0/29	0/62	0/64	1/32
Anorectal varices haemorrhageGastrointestinal disorders	0/68	0/67	1/66	0/33	0/33	0/29	0/62	0/64	0/32
Cerebrovascular accidentNervous system disorders	0/68	1/67	0/66	0/33	0/33	0/29	0/62	0/64	0/32
Genital painReproductive system and breast disorders	0/68	1/67	0/66	0/33	0/33	0/29	0/62	0/64	0/32
Cardiac failure chronicCardiac disorders	1/68	0/67	0/66	0/33	0/33	0/29	0/62	0/64	0/32
Proteus infectionInfections and infestations	1/68	0/67	0/66	0/33	0/33	0/29	0/62	0/64	0/32

Most frequent other events

Showing 10 of 19

Most frequent other events
Event	Part A: Placebo	Part A: Sonelokimab 120 mg	Part A: Sonelokimab 240 mg	Part A: Adalimumab	Part B: Placebo to Sonelokimab 120 mg	Part B: Placebo to Sonelokimab 240 mg	Part B: Sonelokimab 120 mg	Part B: Sonelokimab 240 mg	Part B: Adalimumab to Sonelokimab 240 mg
Oral candidiasisInfections and infestations	0/68	4/67	8/66	0/33	4/33	6/29	4/62	8/64	2/32
NasopharyngitisInfections and infestations	10/68	10/67	6/66	2/33	3/33	5/29	8/62	8/64	2/32
HeadacheNervous system disorders	8/68	6/67	8/66	3/33	2/33	5/29	3/62	1/64	1/32
Upper respiratory tract infectionInfections and infestations	3/68	4/67	7/66	4/33	1/33	2/29	3/62	7/64	2/32
Injection site reactionGeneral disorders	0/68	6/67	6/66	0/33	1/33	3/29	1/62	5/64	1/32
Blood creatine phosphokinase increasedInvestigations	1/68	2/67	4/66	3/33	0/33	0/29	0/62	1/64	0/32
COVID-19Infections and infestations	6/68	4/67	5/66	2/33	0/33	1/29	0/62	1/64	2/32
HidradenitisSkin and subcutaneous tissue disorders	0/68	2/67	1/66	1/33	2/33	2/29	1/62	1/64	1/32
EczemaSkin and subcutaneous tissue disorders	1/68	3/67	0/66	1/33	0/33	2/29	1/62	1/64	1/32
Back painMusculoskeletal and connective tissue disorders	1/68	0/67	0/66	0/33	0/33	2/29	4/62	1/64	1/32

Baseline characteristics

The Full Analysis Set (FAS) included all randomized participants assigned treatment for Part A.

Age, Continuous
Age, Continuous(years)	Part A: Placebo	Part A: Sonelokimab 120 mg	Part A: Sonelokimab 240 mg	Part A: Adalimumab	Total
Mean	39.3 ± 13.05	37.6 ± 10.46	36.2 ± 11.65	37.1 ± 10.55	37.6 ± 11.60

Sex: Female, Male
Sex: Female, Male(Participants)	Part A: Placebo	Part A: Sonelokimab 120 mg	Part A: Sonelokimab 240 mg	Part A: Adalimumab	Total
Female	36	42	42	20	140
Male	32	25	24	13	94

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Part A: Placebo	Part A: Sonelokimab 120 mg	Part A: Sonelokimab 240 mg	Part A: Adalimumab	Total
Hispanic or Latino	3	2	5	2	12
Not Hispanic or Latino	62	63	58	31	214
Unknown or Not Reported	3	2	3	0	8

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Part A: Placebo	Part A: Sonelokimab 120 mg	Part A: Sonelokimab 240 mg	Part A: Adalimumab	Total
American Indian or Alaska Native	0	1	1	1	3
Asian	2	1	3	0	6
Black or African American	3	6	5	2	16
White	59	57	54	29	199
Not reported	4	2	3	1	10

Study locations

57 sites

Clinical Site
Fountain Valley, California 92708, United States
Clinical Site
Los Angeles, California 90056, United States
Clinical Site
Miami, Florida 33136, United States
Clinical Site
Ormond Beach, Florida 32127, United States
Clinical Site
St. Petersburg, Florida 33709, United States
Clinical Site
Tampa, Florida 33613, United States
Clinical Site
Indianapolis, Indiana 46250, United States
Clinical Site
Beverly, Massachusetts 01915, United States
Clinical Site
Boston, Massachusetts 02215, United States
Clinical Site
Omaha, Nebraska 68144, United States
Clinical Site
New York, New York 10003, United States
Clinical Site
Philadelphia, Pennsylvania 19103, United States
Clinical Site
Charleston, South Carolina 29425, United States
Clinical Site
Nashville, Tennessee 37215, United States
Clinical Site
Bellaire, Texas 77401, United States
Clinical Site
Sofia, 1407, Bulgaria
Clinical Site
Sofia, 1431, Bulgaria
Clinical Site
Sofia, 1463, Bulgaria
Clinical Site
Stara Zagora, 6000, Bulgaria
Clinical Site
Calgary, Alberta T3E 0B2, Canada
Clinical Site
Winnipeg, Manitoba R3M 3Z4, Canada
Clinical Site
Fredericton, New Brunswick E3B 1G9, Canada
Clinical Site
St. John's, Newfoundland and Labrador A1A 4Y3, Canada
Clinical Site
Hamilton, Ontario L8L 3C3, Canada
Clinical Site
London, Ontario N6H 5L5, Canada
Clinical Site
Markham, Ontario L3P 1X2, Canada
Clinical Site
Newmarket, Ontario L3Y 5G8, Canada
Clinical Site
Peterborough, Ontario K9J 5K2, Canada
Clinical Site
Saskatoon, Saskatchewan S7K 2C1, Canada
Clinical Site
Bad Bentheim, 48455, Germany
Clinical Site
Berlin, 10117, Germany
Clinical Site
Berlin, 10789, Germany
Clinical Site
Berlin, 13595, Germany
Clinical Site
Bochum, 44791, Germany
Clinical Site
Darmstadt, 64283, Germany
Clinical Site
Dresden, 01307, Germany
Clinical Site
Frankfurt, 60590, Germany
Clinical Site
Hamburg, 20246, Germany
Clinical Site
Kiel, 24105, Germany
Clinical Site
Lübeck, 23538, Germany
Clinical Site
Mahlow, 15831, Germany
Clinical Site
München, 80337, Germany
Clinical Site
Münster, 48149, Germany
Clinical Site
Dublin, D04 T6F4, Ireland
Clinical Site
Bergen op Zoom, 4624, Netherlands
Clinical Site
Rotterdam, 3015 GD, Netherlands
Clinical Site
Gdansk, 80-214, Poland
Clinical Site
Krakow, 31-033, Poland
Clinical Site
Lodz, 90-265, Poland
Clinical Site
Olsztyn, 10-341, Poland
Clinical Site
Ossy, 42-624, Poland
Clinical Site
Ostrowiec Świętokrzyski, 27-400, Poland
Clinical Site
Poznan, 60-681, Poland
Clinical Site
Warsaw, 02-507, Poland
Clinical Site
Warsaw, 02-692, Poland
Clinical Site
Wroclaw, 50566, Poland
Clinical Site
Wroclaw, 51318, Poland

References and documents

Study documents

Study protocol ↗ · Aug 16, 2022
Statistical analysis plan ↗ · May 23, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2022 to primary completion in May 2023, 12 months.

Results were first posted in Sep 2026, 3 years 4 months after primary completion. A results delay was requested in May 2024.

Of 44 industry-sponsored phase 2 interventional studies under Hidradenitis Suppurativa, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 20. This study's 12 months is below that.

Counting every sponsor, half of 54 studies reached it within 15 months; a quarter within 11 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 4, 2022
First posted: Apr 11, 2022
StartActual: Apr 25, 2022
Primary completionActual: May 9, 2023
CompletionActual: Aug 30, 2023
Results delay requested: May 1, 2024
Results first posted: Sep 9, 2026
Last update: Sep 9, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05322473
Lead sponsor: MoonLake Immunotherapeutics AG
Responsible party: Sponsor
First posted: Apr 11, 2022
Start date: Apr 25, 2022
Primary completion: May 9, 2023
Completion: Aug 30, 2023
Results posted: Sep 9, 2026
Last update: Sep 9, 2026

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study director · MoonLake Immunotherapeutics AG

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FDA-regulated drug: Yes
FDA-regulated device: No

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Sonelokimab

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MoonLake Immunotherapeutics AG

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

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