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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2023-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hidradenitis Suppurativa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Group Type EXPERIMENTAL

Sonelokimab (M1095)

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Sonelokimab (M1095)

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Adalimumab

Intervention Type DRUG

randomized treatment; parallel-group

Interventions

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Sonelokimab (M1095)

randomized treatment; parallel-group

Intervention Type DRUG

Adalimumab

randomized treatment; parallel-group

Intervention Type DRUG

Placebo

randomized treatment; parallel-group

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Participant is ≥18 years of age;
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

1. Participants with known hypersensitivity to sonelokimab or any of its excipients;
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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MoonLake Immunotherapeutics AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

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Los Angeles, California, United States

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Miami, Florida, United States

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Ormond Beach, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Indianapolis, Indiana, United States

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Beverly, Massachusetts, United States

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Boston, Massachusetts, United States

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Omaha, Nebraska, United States

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New York, New York, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Nashville, Tennessee, United States

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Bellaire, Texas, United States

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Calgary, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Fredericton, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Markham, Ontario, Canada

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Newmarket, Ontario, Canada

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Peterborough, Ontario, Canada

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Saskatoon, Saskatchewan, Canada

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Bad Bentheim, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bochum, , Germany

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Darmstadt, , Germany

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Dresden, , Germany

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Frankfurt, , Germany

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Hamburg, , Germany

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Kiel, , Germany

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Lübeck, , Germany

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Mahlow, , Germany

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München, , Germany

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Münster, , Germany

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Dublin, , Ireland

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Bergen op Zoom, , Netherlands

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Rotterdam, , Netherlands

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Gdansk, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Olsztyn, , Poland

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Ossy, , Poland

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Ostrowiec Świętokrzyski, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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Countries

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United States Bulgaria Canada Germany Ireland Netherlands Poland

Other Identifiers

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M1095-HS-201

Identifier Type: -

Identifier Source: org_study_id

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