A Phase 3 interventional study of Sonelokimab in Hidradenitis Suppurativa, sponsored by MoonLake Immunotherapeutics AG. Enrolling by invitation at 166 sites in 16 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by MoonLake Immunotherapeutics AG · Phase 3, Interventional, and Treatment
This is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who were previously enrolled in a parental study.
284 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.
This study's planned enrollment of 835 is above the median of 45 across 199 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →MoonLake Immunotherapeutics AG is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive sonelokimab 120 mg Q4W for up to 2 years
Drug: Sonelokimab
Sonelokimab
Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab
Incidence, relatedness, severity and seriousness of all AEs
Time frame: 2.5-3 years
Long-term safety and tolerability of sonelokimab: Treatment emergent adverse events (TEAEs)
Incidence, relatedness, severity and seriousness of all TEAEs
Time frame: 2.5-3 years
Long-term safety and tolerability of sonelokimab: Adverse events of special interest (AESIs)
Incidence, relatedness, severity and seriousness of all AESIs
Time frame: 2.5-3 years
Long-term safety and tolerability of sonelokimab: Discontinuation of sonelokimab treatment due to AEs
Number of participants discontinued from sonelokimab treatment due to AEs
Time frame: 2.5-3 years
Long-term safety and tolerability of sonelokimab: Clinically significant changes in clinical laboratory parameters
Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline
Time frame: 2.5-3 years
Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram
Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline
Time frame: 2.5-3 years
Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Percentage of participants achieving a HiSCR75 response over time
Time frame: 2.5 - 3 years
Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) and 50 (HiSCR50)
Percentage of participants achieving a HiSCR90 and HiSCAR50 response over time
Time frame: 2.5 - 3 years
Long-term efficacy of sonelokimab: International Hidradenitis Suppurativa Severity Score System (IHS4)
Absolute change in IHS4 score over time
Time frame: 2.5 - 3 years
Long-term efficacy of sonelokimab: Number of abscesses, draining fistulas/tunnels; inflammatory nodules
Absolute change in number of abscesses, draining fistulas/tunnels; inflammatory nodules
Time frame: 2.5 - 3 years
Long-term efficacy of sonelokimab: Dermatology Life Quality Index (DLQI)
Change in DLQI total score
Time frame: 2.5 - 3 years
Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Quality of Life (HiSQOL)
Change in HiSQOL total score
Time frame: 2.5 - 3 years
Showing the first 100 of 166 sites across 16 countries. Choose a country and city above to see the rest.
Started Jun 2025 (actual). Primary completion is estimated for Jun 2028, 35 months after the start.
Of 26 phase 3 interventional studies under Hidradenitis Suppurativa, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 38. This study's planned 35 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: Sonelokimab
MoonLake Immunotherapeutics AG