Arthritis, Psoriatic
Conditions
Brief summary
This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.
Detailed description
M1095-PSA-301 is a Phase 3, multicenter, randomized, parallel-group, double-blind, 3-arm, placebo-controlled study to investigate the efficacy and safety of sonelokimab 60 mg every 4 weeks (with and without an induction regimen) versus placebo in adults with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.
Interventions
DRUGSonelokimab
Randomized treatment, parallel-group
DRUGPlacebo
Randomized treatment, parallel-group
Sponsors
MoonLake Immunotherapeutics AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants must be ≥18 years of age . 2. Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit. 3. Participants have active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3). 4. Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO. 5. Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.
Exclusion criteria
1. Participants with a known hypersensitivity to sonelokimab or any of its excipients. 2. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA. 3. Participants with a diagnosis of inflammatory bowel disease. 4. Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit. 5. Participants who have an established diagnosis of arthritis mutilans. 6. Previous exposure to sonelokimab. 7. Participants who have ever received any biologic immunomodulating agents for PsA or PsO, whether investigational or approved.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50) | Week 16 | Proportion of participants achieving ACR50 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20) | Week 16 | Proportion of participants achieving ACR20 |
| Response rate of participants achieving Minimal Disease Activity (MDA) | Week 16 | Proportion of participants achieving MDA |
| Health Assessment Questionnaire- Disability Index (HAQ-DI) | Week 16 | Change in HAQ-DI from baseline |
| Psoriasis Area and Severity Index (PASI90) | Week 16 | 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 |
| Short- form-36 (SF-36) Physical Component Summary (PCS) | Week 16 | Change from Baseline in SF-36 PCS at Week 16 |
| van der Heijde modified Total Sharp Score (vdHmTSS) | Week 16 | Change from Baseline to Week 16 in joint/bone structural damage (vdHmTSS) |
Countries
Bulgaria, Canada, Croatia, Czechia, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Latvia, Lithuania, Poland, Portugal, Romania, Serbia, Slovakia, Spain, United States
Outcome results
None listed