Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

May 8, 2024 updated by: MoonLake Immunotherapeutics AG

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants must be at least 18 years of age at the time of signing the informed consent.
  2. Participants who are diagnosed with hidradenitis suppurativa as determined by the investigator and have a history of signs and symptoms of hidradenitis suppurativa for at least 6 months before signing the informed consent.
  3. Participants who have 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.
  4. Participants who have a total AN count of ≥5.
  5. Participants who have HS lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (ie, be Hurley Stage II or III).

Exclusion Criteria:

  1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.
  2. Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
  3. Participants with underlying conditions that, in the opinion of the investigator, potentially places the participant at unacceptable risk.
  4. Participants with current severe or uncontrolled disease(s) that put(s) the participant at increased risk in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
  5. Participants with any other known autoimmune disease or any medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS.
  6. Participants with a gastrointestinal condition including inflammatory bowel disease or 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sonelokimab
Subjects randomized to this arm will receive sonelokimab from Weeks 0-48.
Drug: Sonelokimab
Sonelokimab
Placebo Comparator: Placebo
Subjects randomized to this arm will receive placebo from Weeks 0-16. They will receive sonelokimab from weeks 16-48
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hidradenitis Suppurativa Clinical Response 75
Time Frame: Week 16
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 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hidradenitis Suppurativa Clinical Response 50
Time Frame: Week 16
Percentage of participants achieving HiSCR50
Week 16
Change in International Hidradenitis Suppurativa Severity Score System
Time Frame: Week 16

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

The IHS4 score is calculated as follows: number of nodules (multiplied by 1) + number of abscesses (multiplied by 2) + 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 16
Dermatology Life Quality Index (DLQI)
Time Frame: Week 16
Percentage of participants achieving a DLQI total reduction of ≥4 minimal clinically important difference among participants with a baseline DLQI ≥4
Week 16
Reduction from Numerical Rating Scale (NRS30 & NRS50) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)
Time Frame: week 16
Percentage of participants achieving at least ≥30% (and ≥50%) reduction and at least 2-unit reduction from Baseline in Numerical Rating Scale (NRS30 & NRS50) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3
week 16
Patient Global Impression - Severity of Illness - Hidradenitis Suppurativa at Week 16
Time Frame: Week 16
Patient Global Impression - Severity of Illness - Hidradenitis Suppurativa at Week 16
Week 16
Resolution of draining tunnels (DT100)
Time Frame: Week 16 and Week 52
Resolution of draining tunnels (DT100)
Week 16 and Week 52

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 (Estimated)

May 22, 2024

Primary Completion (Estimated)

June 17, 2025

Study Completion (Estimated)

June 17, 2026

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 8, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M1095-HS-302
  • VELA-2 (Other Identifier: Sponsor)

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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