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Monoclonal Antibodies

Sonelokimab (M1095) for Hidradenitis Suppurativa

Phase 2
Waitlist Available
Research Sponsored by MoonLake Immunotherapeutics AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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;
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;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Study Summary

This trial will show if a new medication is effective and safe for people with a skin condition called hidradenitis suppurativa.

Eligible Conditions
  • Hidradenitis Suppurativa

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with hidradenitis suppurativa by a doctor and have experienced symptoms for at least 6 months before the screening visit.
Select...
You have tried antibiotics to treat your hidradenitis suppurativa but they did not work or you cannot take them due to side effects or other reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 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
+1 more

Side effects data

From 2013 Phase 4 trial • 50 Patients • NCT01644396
8%
LATENT TUBERCULOSIS
6%
RHINITIS
2%
ORAL HERPES
2%
RESPIRATORY TRACT INFECTION
2%
CONTUSION
2%
EXCORIATION
2%
ASPARTATE AMINOTRANSFERASE INCREASED
2%
BLOOD GLUCAGON INCREASED
2%
BLOOD TRIGLYCERIDES INCREASED
2%
RENAL COLIC
2%
EPISTAXIS
2%
URTICARIA
2%
ANAEMIA
2%
FURUNCLE
2%
HERPES SIMPLEX
2%
ALANINE AMINOTRANSFERASE INCREASED
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adalimumab

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: sonelokimab dose 2Experimental Treatment1 Intervention
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.
Group II: sonelokimab dose 1Experimental Treatment1 Intervention
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.
Group III: adalimumabActive Control1 Intervention
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.
Group IV: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sonelokimab (M1095)
2022
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

MoonLake Immunotherapeutics AGLead Sponsor
1 Previous Clinical Trials
207 Total Patients Enrolled
Prof. Kristian Reich, M.D., Ph.D. (equ.)Study DirectorMoonLake Immunotherapeutics AG

Media Library

Sonelokimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05322473 — Phase 2
Hidradenitis Suppurativa Research Study Groups: sonelokimab dose 2, Placebo, adalimumab, sonelokimab dose 1
Hidradenitis Suppurativa Clinical Trial 2023: Sonelokimab Highlights & Side Effects. Trial Name: NCT05322473 — Phase 2
Sonelokimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05322473 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What severe adverse effects have been linked with Sonelokimab (M1095) use?

"While Phase 2 trials do not have the same level of efficacy data, Sonelokimab (M1095) has been determined to be safe."

Answered by AI

How many people are being given the opportunity to participate in this clinical trial?

"The answer is affirmative, active recruitment is taking place for this clinical trial according to the information on clinicaltrials.gov. This specific study was initially posted on April 25th, 2022 and updated November 7th of the same year. The total number of patients needed for participation is 210, recruited from 33 different sites."

Answered by AI

Are there any available positions for patients in this clinical trial?

"Yes, the trial is currently ongoing. According to the listing on clinicaltrials.gov, it was posted on 4/25/2022 and last edited on 11/7/2022. They are looking for a total of 210 patients from 33 different sites."

Answered by AI

Is this research study also taking place in other states besides the one where it began?

"This particular clinical trial has 33 enrollment sites which are situated in Markham, Beverly, Fredericton, and 30 other cities. To limit travel-related inconveniences, it is recommended that you choose a location near to you."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
Clinical Site
What portion of applicants met pre-screening criteria?
Met criteria
~80 spots leftby Mar 2025