Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: sonelokimab dose regimen 1 Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 1 |
Drug: Sonelokimab
randomized treatment; parallel group
Other Names:
|
Experimental: sonelokimab dose regimen 2 Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 2 |
Drug: Sonelokimab
randomized treatment; parallel group
Other Names:
|
Experimental: sonelokimab dose regimen 3 Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 3 |
Drug: Sonelokimab
randomized treatment; parallel group
Other Names:
|
Placebo Comparator: Placebo Subjects randomized to this arm will receive placebo |
Drug: Placebo
randomized treatment; parallel-group
|
Active Comparator: adalimumab Subjects randomized to this arm will receive adalimumab |
Drug: Adalimumab
randomized treatment; parallel-group
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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)
- Leeds Dactylitis Index (LDI) [Weeks 4, 8, 12]
Change from baseline for Leeds Dactylitis Index
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant is ≥18 years of age;
-
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;
-
Participant has active disease (defined by a TJC68 of ≥3 and a SJC66 of ≥3);
-
Participant has either current active PsO or a dermatologist confirmed history of PsO;
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Participant tests negative for rheumatoid factor (RF) at the Screening Visit;
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Participant tests negative for anti-cyclic citrullinated peptide (CCP) antibodies at the Screening Visit;
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Participant must be, in the opinion of the investigator, a suitable candidate for treatment with adalimumab per approved local product information.
Exclusion Criteria:
-
Participant with known hypersensitivity to sonelokimab or any of its excipients;
-
Participant with known hypersensitivity to adalimumab or any of its excipients;
-
Participant who has previously failed on anti-interleukin (IL)-17 therapy;
-
Participant who has previously failed on anti-tumor necrosis factor alpha (TNFα) therapy;
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Participant who has had previous exposure to more than 2 biologic agents of any type to treat PsA prior to the Screening Visit;
-
Participant who has a diagnosis of chronic inflammatory conditions other than PsO or PsA;
-
Participant who has a diagnosis of arthritis mutilans
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Clinical Site | Rancho Mirage | California | United States | 92260 |
2 | Clinical Site | Duncansville | Pennsylvania | United States | 16635 |
3 | Clinical Site | Plovdiv | Bulgaria | 4002 | |
4 | Clinical Site | Stara Zagora | Bulgaria | 6000 | |
5 | Clinical Site | Białystok | Poland | 15-879 | |
6 | Clinical Site | Nowa Sól | Poland | 67-100 | |
7 | Clinical Site | Olsztyn | Poland | 10-117 | |
8 | Clinical Site | Poznan | Poland | 61-113 | |
9 | Clinical Site | Swidnica | Poland | 58-100 | |
10 | Clinical SIte | Wrocław | Poland | 52-416 | |
11 | Clinical Site | Łódź | Poland | 90-242 |
Sponsors and Collaborators
- MoonLake Immunotherapeutics AG
Investigators
- Study Director: Kristian Reich, M.D., Ph.D. (equ.), MoonLake Immunotherapeutics AG
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M1095-PSA-201