Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa
Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Moderate to Severe Hidradenitis Suppurativa
1 other identifier
interventional
234
7 countries
57
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2022
Shorter than P25 for phase_2
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedStudy Start
First participant enrolled
April 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedMay 3, 2024
May 1, 2024
1 year
April 4, 2022
May 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Week 12
Secondary Outcomes (4)
Hidradenitis Suppurativa Clinical Response 50
Week 12
Change in International Hidradenitis Suppurativa Severity Score System
Week 12
Dermatology Life Quality Index (DLQI)
Week 12
Reduction from Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)
Week 12
Study Arms (4)
sonelokimab dose 1
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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 COMPARATORSubjects 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 COMPARATORSubjects 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Prof. Kristian Reich, M.D., Ph.D. (equ.)
MoonLake Immunotherapeutics AG
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2022
First Posted
April 11, 2022
Study Start
April 25, 2022
Primary Completion
May 9, 2023
Study Completion
August 30, 2023
Last Updated
May 3, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share