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

Hidradenitis Suppurativa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05322473
• Other study ID #: M1095-HS-201
• Status: Completed
• Phase: Phase 2
• Start date: April 25, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: May 2024
• Source: MoonLake Immunotherapeutics AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: August 30, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• Sonelokimab (M1095)
randomized treatment; parallel-group
• Adalimumab
randomized treatment; parallel-group

Other:
• Placebo
randomized treatment; parallel-group

Locations

Country	Name	City	State
Bulgaria	Clinical Site	Sofia
Bulgaria	Clinical Site	Sofia
Bulgaria	Clinical Site	Sofia
Bulgaria	Clinical Site	Stara Zagora
Canada	Clinical Site	Calgary	Alberta
Canada	Clinical Site	Fredericton	New Brunswick
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	Saint John's	Newfoundland and Labrador
Canada	Clinical Site	Saskatoon	Saskatchewan
Canada	Clinical Site	Winnipeg	Manitoba
Germany	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	Luebeck
Germany	Clinical Site	Mahlow
Germany	Clinical Site	München
Germany	Clinical Site	Münster
Ireland	Clinical Site	Dublin
Netherlands	Clinical Site	Bergen Op Zoom
Netherlands	Clinical Site	Rotterdam
Poland	Clinical Site	Gdansk
Poland	Clinical Site	Kraków
Poland	Clinical Site	Lódz
Poland	Clinical Site	Olsztyn
Poland	Clinical Site	Ossy
Poland	Clinical Site	Ostrowiec Swietokrzyski
Poland	Clinical Site	Poznan
Poland	Clinical Site	Warszawa
Poland	Clinical Site	Warszawa
Poland	Clinical Site	Wroclaw
Poland	Clinical Site	Wroclaw
United States	Clinical Site	Bellaire	Texas
United States	Clinical Site	Beverly	Massachusetts
United States	Clinical Site	Boston	Massachusetts
United States	Clinical Site	Charleston	South Carolina
United States	Clinical Site	Fountain Valley	California
United States	Clinical Site	Indianapolis	Indiana
United States	Clinical Site	Los Angeles	California
United States	Clinical Site	Miami	Florida
United States	Clinical Site	Nashville	Tennessee
United States	Clinical Site	New York	New York
United States	Clinical Site	Omaha	Nebraska
United States	Clinical Site	Ormond Beach	Florida
United States	Clinical Site	Philadelphia	Pennsylvania
United States	Clinical Site	Saint Petersburg	Florida
United States	Clinical Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
MoonLake Immunotherapeutics AG

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Germany,  Ireland,  Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hidradenitis Suppurativa Clinical Response 50	Proportion of participants achieving HiSCR50	Week 12
Secondary	Change in International Hidradenitis Suppurativa Severity Score System	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
Secondary	Dermatology Life Quality Index (DLQI)	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
Secondary	Reduction from Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)	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