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

Hidradenitis Suppurativa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06411379
• Other study ID #: M1095-HS-302
• Secondary ID: VELA-2
• Status: Recruiting
• Phase: Phase 3
• Start date: May 14, 2024
• Est. completion date: June 17, 2026

Study information

• Verified date: May 2024
• Source: MoonLake Immunotherapeutics AG
• Contact: Moonlake Clinical Trial Helpdesk
• Phone: +41 41 510 8022
• Email: ClinicalTrials[@]moonlaketx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 17, 2026
• Est. primary completion date: June 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• Sonelokimab
Sonelokimab
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Clinical Site	Birmingham	Alabama
United States	Clinical Site	Plainfield	Indiana
United States	Clinical Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
MoonLake Immunotherapeutics AG

Country where clinical trial is conducted

United States, 

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 16
Secondary	Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)	Percentage of participants achieving HiSCR50	Week 16
Secondary	Change in International Hidradenitis Suppurativa Severity Score System	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
Secondary	Dermatology Life Quality Index (DLQI)	Percentage of participants achieving a DLQI total reduction of =4 minimal clinically important difference among participants with a baseline DLQI =4. DLQI produces a numeric score that can range from 0 to 30. A higher score indicates greater health related quality of life impairment.	Week 16
Secondary	Reduction from Numerical Rating Scale (NRS30 & NRS50) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)	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
Secondary	Patient Global Impression - Severity of Illness - Hidradenitis Suppurativa at Week 16	Percentage of participants with minimal or absent symptoms using the Patient Global Impression - Severity of Illness - Hidradenitis Suppurativa at Week 16. Participants choose the response that best describes the severity of their disease. The question is rated on a 7-point scale ranging from 0 to 6 (0=absent; 1=minimal; 2=mild; 3=moderate; 4=moderately severe; 5=severe; 6=very severe).	Week 16
Secondary	Resolution of draining tunnels (DT100)	Percentage of participants with zero draining tunnels in the subgroup of participants with at least one draining tunnel at baseline (DT100)	Week 16 and Week 52