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

May 1, 2024 updated by: MoonLake Immunotherapeutics AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Sonelokimab (M1095)
randomized treatment; parallel-group
Experimental: 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.
Drug: Sonelokimab (M1095)
randomized treatment; parallel-group
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
randomized treatment; parallel-group
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
randomized treatment; parallel-group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hidradenitis Suppurativa Clinical Response 75
Time Frame: Week 12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hidradenitis Suppurativa Clinical Response 50
Time Frame: Week 12
Proportion of participants achieving HiSCR50
Week 12
Change in International Hidradenitis Suppurativa Severity Score System
Time Frame: Week 12

Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)

The IHS4 score is calculated as follows: 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 or less signifies mild, 4 to 10 signifies moderate and 11 or higher signifies severe disease.
Week 12
Dermatology Life Quality Index (DLQI)
Time Frame: Week 12

Proportion of participants achieving a Dermatology Life Quality Index (DLQI) total score of ≤5

The DLQI produces a numeric score that can range from 0 to 30. A higher score indicates greater health-related quality of life impairment.
Week 12
Reduction from Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)
Time Frame: Week 12

Proportion of participants achieving at least 30% reduction and at least 2-unit reduction from Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3

The NRS is a numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine).
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MoonLake Immunotherapeutics AG

Investigators

  • Study Director: Prof. Kristian Reich, M.D., Ph.D. (equ.), MoonLake Immunotherapeutics AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2022

Primary Completion (Actual)

May 9, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M1095-HS-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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