Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa
NCT ID: NCT05322473
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
234 participants
INTERVENTIONAL
2022-04-25
2023-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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sonelokimab dose 1
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 (M1095)
randomized treatment; parallel-group
sonelokimab dose 2
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 (M1095)
randomized treatment; parallel-group
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.
Placebo
randomized treatment; parallel-group
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.
Adalimumab
randomized treatment; parallel-group
Interventions
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Sonelokimab (M1095)
randomized treatment; parallel-group
Adalimumab
randomized treatment; parallel-group
Placebo
randomized treatment; parallel-group
Eligibility Criteria
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Inclusion Criteria
2. 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;
3. Participant has a total abscess and/or inflammatory nodule (AN) count of ≥5;
4. 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);
5. 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;
6. 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
2. Participants with known hypersensitivity to adalimumab or any of its excipients;
3. Participant has a draining fistula count of ≥20 at the Screening Visit;
4. Participant has any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of hidradenitis suppurativa;
5. Prior exposure to more than 2 biologic response modifiers;
6. Participant has a diagnosis of ulcerative colitis or Crohn's disease.
18 Years
ALL
No
Sponsors
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MoonLake Immunotherapeutics AG
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Kristian Reich, M.D., Ph.D. (equ.)
Role: STUDY_DIRECTOR
MoonLake Immunotherapeutics AG
Locations
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Clinical Site
Fountain Valley, California, United States
Clinical Site
Los Angeles, California, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Ormond Beach, Florida, United States
Clinical Site
St. Petersburg, Florida, United States
Clinical Site
Tampa, Florida, United States
Clinical Site
Indianapolis, Indiana, United States
Clinical Site
Beverly, Massachusetts, United States
Clinical Site
Boston, Massachusetts, United States
Clinical Site
Omaha, Nebraska, United States
Clinical Site
New York, New York, United States
Clinical Site
Philadelphia, Pennsylvania, United States
Clinical Site
Charleston, South Carolina, United States
Clinical Site
Nashville, Tennessee, United States
Clinical Site
Bellaire, Texas, United States
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Stara Zagora, , Bulgaria
Clinical Site
Calgary, Alberta, Canada
Clinical Site
Winnipeg, Manitoba, Canada
Clinical Site
Fredericton, New Brunswick, Canada
Clinical Site
St. John's, Newfoundland and Labrador, Canada
Clinical Site
Hamilton, Ontario, Canada
Clinical Site
London, Ontario, Canada
Clinical Site
Markham, Ontario, Canada
Clinical Site
Newmarket, Ontario, Canada
Clinical Site
Peterborough, Ontario, Canada
Clinical Site
Saskatoon, Saskatchewan, Canada
Clinical Site
Bad Bentheim, , Germany
Clinical Site
Berlin, , Germany
Clinical Site
Berlin, , Germany
Clinical Site
Berlin, , Germany
Clinical Site
Bochum, , Germany
Clinical Site
Darmstadt, , Germany
Clinical Site
Dresden, , Germany
Clinical Site
Frankfurt, , Germany
Clinical Site
Hamburg, , Germany
Clinical Site
Kiel, , Germany
Clinical Site
Lübeck, , Germany
Clinical Site
Mahlow, , Germany
Clinical Site
München, , Germany
Clinical Site
Münster, , Germany
Clinical Site
Dublin, , Ireland
Clinical Site
Bergen op Zoom, , Netherlands
Clinical Site
Rotterdam, , Netherlands
Clinical Site
Gdansk, , Poland
Clinical Site
Krakow, , Poland
Clinical Site
Lodz, , Poland
Clinical Site
Olsztyn, , Poland
Clinical Site
Ossy, , Poland
Clinical Site
Ostrowiec Świętokrzyski, , Poland
Clinical Site
Poznan, , Poland
Clinical Site
Warsaw, , Poland
Clinical Site
Warsaw, , Poland
Clinical Site
Wroclaw, , Poland
Clinical Site
Wroclaw, , Poland
Countries
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Other Identifiers
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M1095-HS-201
Identifier Type: -
Identifier Source: org_study_id
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