A Phase 3 interventional study of Sonelokimab and Placebo in Arthritis, Psoriatic, sponsored by MoonLake Immunotherapeutics AG. Active, not recruiting at 143 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by MoonLake Immunotherapeutics AG · Phase 3, Interventional, and Treatment
This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.
M1095-PSA-302 is a Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm to investigate the efficacy and safety of sonelokimab 60 mg and 120 mg versus placebo in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.
600 studies on the registry are indexed under Arthritis, Psoriatic; 129 are open to participants now.
This study's planned enrollment of 600 is above the median of 145 across 336 interventional studies indexed under Arthritis, Psoriatic.
Browse Arthritis, Psoriatic 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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects randomized to this arm will receive sonelokimab dose 1 subcutaneously (SC) as an induction regimen of 4 doses , followed by sonelokimab SC every 4 weeks (Q4W) maintenance dosing starting at Week 8.
Drug: Sonelokimab
Subjects randomized to this arm will receive sonelokimab dose 2 SC as an induction regimen of 4 doses, followed by sonelokimab SC Q4W maintenance dosing starting at Week 8.
Drug: Sonelokimab
Subjects randomized to this arm will receive placebo SC
Drug: Placebo
Subjects randomized to this arm will receive risankizumab SC
Drug: Risankizumab
Sonelokimab
Placebo
Active comparator
Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
Proportion of participants achieving ACR50
Time frame: Week 16 compared to placebo
Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20)
Proportion of participants achieving ACR20
Time frame: Week 16 compared to placebo
Response rate of participants achieving Minimal Disease Activity (MDA)
Proportion of participants achieving MDA
Time frame: Week 16 compared to placebo
Health Assessment Questionnaire- Disability Index (HAQ-DI)
Change in HAQ-DI from baseline
Time frame: Week 16 compared to placebo
Psoriasis Area and Severity Index (PASI90)
Proportion of participants achieving a decrease of ≥90% in the PASI90 response at Week 16 in the subgroup of participants with psoriasis (PsO) involving ≥3% body surface area at baseline
Time frame: Week 16 compared to placebo
Short- form-36 (SF-36) Physical Component Summary (PCS)
Change from Baseline in SF-36 PCS at Week 16
Time frame: Week 16 compared to placebo
Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
Proportion of participants achieving ACR50
Time frame: Week 16 compared to risankzumab
Showing the first 100 of 143 sites across 11 countries. Choose a country and city above to see the rest.
Started Oct 2024 (actual). Primary completion is estimated for Jan 2027, 26 months after the start.
Of 68 industry-sponsored phase 3 interventional studies under Arthritis, Psoriatic, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 39. This study's planned 26 months is close to that.
Counting every sponsor, half of 74 studies reached it within 28 months; a quarter within 19 and three quarters within 42.
Completion moved once since we started tracking on Sep 25, 2026: Jan 2027 → Sep 2027, on Oct 9, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sonelokimab
MoonLake Immunotherapeutics AG