Arthritis, Psoriatic
Conditions
Keywords
Arthritis, Psoriatic, Skin Diseases, Joint Diseases, Arthritis, Psoriasis
Brief summary
This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis. The study includes adalimumab treatment as an active reference arm.
Detailed description
Patients will be randomized to receive one of three sonelokimab treatment regimes, adalimumab or placebo. Primary efficacy evaluation will take place at Week 12. Patients will be allocated to a further 12 weeks of treatment with sonelokimab or adalimumab based on response assessment at week 12. In certain countries, treatment will end at week 12.
Interventions
DRUGSonelokimab
randomized treatment; parallel group
DRUGPlacebo
randomized treatment; parallel-group
DRUGAdalimumab
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. Participant is ≥18 years of age; 2. Participant has a confirmed diagnosis of PsA per the 2006 Classification criteria for Psoriatic Arthritis (CASPAR) with symptoms for ≥6 months prior to the Screening Visit; 3. Participant has active disease (defined by a TJC68 of ≥3 and a SJC66 of ≥3); 4. Participant has either current active PsO or a dermatologist confirmed history of PsO; 5. Participant tests negative for rheumatoid factor (RF) at the Screening Visit; 6. Participant tests negative for anti-cyclic citrullinated peptide (CCP) antibodies at the Screening Visit; 7. Participant must be, in the opinion of the investigator, a suitable candidate for treatment with adalimumab per approved local product information.
Exclusion criteria
1. Participant with known hypersensitivity to sonelokimab or any of its excipients; 2. Participant with known hypersensitivity to adalimumab or any of its excipients; 3. Participant who has previously failed on anti-interleukin (IL)-17 therapy; 4. Participant who has previously failed on anti-tumor necrosis factor alpha (TNFα) therapy; 5. Participant who has had previous exposure to more than 2 biologic agents of any type to treat PsA prior to the Screening Visit; 6. Participant who has a diagnosis of chronic inflammatory conditions other than PsO or PsA; 7. Participant who has a diagnosis of arthritis mutilans
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 12 | Proportion of participants who achieve ACR50 compared with baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) 90 | Week 4, 8, 12 | Proportion of participants who achieve PASI90 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline |
| Response rate of participants achieving at least a 70% improvement in the American College of Rheumatology criteria | Weeks 2, 4, 8, 12 | Proportion of participants who achieve ACR70 compared with baseline |
| Leeds Enthesitis Index (LEI) | Weeks 4, 8, 12 | Proportion of participants with resolution of enthesitis (LEI = 0) |
| Response Rate of participants achieving at least a 20% improvement in the American College of Rheumatology criteria (ACR20) | Week 2, 4, 8, 12 | Proportion of participants who achieve ACR20 compared with baseline |
| Modified Nail Psoriasis Severity Index (mNAPSI) | Week 12 | Change from baseline for mNAPSI |
| Psoriasis Area and Severity Index (PASI) 100 | Weeks 4, 8, 12 | Proportion of participants who achieve PASI100 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline |
| Leeds Dactylitis Index (LDI) | Weeks 4, 8, 12 | Change from baseline for Leeds Dactylitis Index |
Countries
Bulgaria, Czechia, Estonia, Germany, Hungary, Poland, Spain, United States
Outcome results
None listed