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Monoclonal Antibodies

Sonelokimab for Hidradenitis Suppurativa

Phase 3
Recruiting
Research Sponsored by MoonLake Immunotherapeutics AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be at least 18 years of age at the time of signing the informed consent
Participants with inadequate response to systemic antibiotics for treatment of hidradenitis suppurativa
Must not have
Participants with any other active skin disease or condition that may interfere with the assessment of HS
Participants with any other known autoimmune disease or medical condition that would interfere with an accurate assessment of clinical symptoms of HS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16 and week 52
Awards & highlights

Summary

This trial will test a new drug called sonelokimab to see if it is effective and safe for treating adults with moderate to severe hidradenitis suppurativa. Participants will be randomly

Who is the study for?
Adults with moderate to severe hidradenitis suppurativa (HS), a skin condition, who haven't responded well to antibiotics can join this trial. They must have had HS symptoms for at least 6 months and have lesions in two or more areas, one with fistulas.
What is being tested?
The study is testing Sonelokimab, given under the skin, against a placebo to see if it's better for treating HS. Participants are randomly chosen to get either the real drug or placebo in a 2:1 ratio until Week 16 of the study.
What are the potential side effects?
Possible side effects of Sonelokimab may include reactions at the injection site, increased risk of infections due to immune system changes, headaches, fatigue and possibly other immune-related conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
My skin condition didn't improve with antibiotics.
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I have HS lesions in 2 or more areas, with at least one area having fistulas.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any skin conditions that could affect HS assessment.
Select...
I do not have any autoimmune diseases that could affect my HS symptom assessment.
Select...
I have a gastrointestinal condition like IBD, ulcerative colitis, or Crohn's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hidradenitis Suppurativa Clinical Response 75
Secondary outcome measures
Change in International Hidradenitis Suppurativa Severity Score System
Dermatology Life Quality Index (DLQI)
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: sonelokimabExperimental Treatment1 Intervention
Subjects randomized to this arm will receive sonelokimab 120 mg Q2W from Weeks 0 to 6 then 120 mg Q4W starting at Week 8 up to Week 48.
Group II: PlaceboPlacebo Group1 Intervention
Subjects randomized to this arm will receive placebo Q2W from Weeks 0 to 6 then Q4W starting at Week 8 up to Week 16. They will receive sonelokimab 120 mg Q2W for 4 doses from Weeks 16 to 22 then Q4W from Week 24 up to Week 48
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sonelokimab
2022
Completed Phase 2
~210

Find a Location

Who is running the clinical trial?

MoonLake Immunotherapeutics AGLead Sponsor
3 Previous Clinical Trials
841 Total Patients Enrolled
2 Trials studying Hidradenitis Suppurativa
634 Patients Enrolled for Hidradenitis Suppurativa
Prof Kristian Reich, M.D., Ph.D. (equ.)Study DirectorMoonLake Immunotherapeutics AG
1 Previous Clinical Trials
400 Total Patients Enrolled
1 Trials studying Hidradenitis Suppurativa
400 Patients Enrolled for Hidradenitis Suppurativa
~267 spots leftby Jun 2025
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