Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Psoriatic Arthritis

Conditions
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Arthritis, Psoriatic

Intervention / Treatment
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* Drug: Sonelokimab
* Drug: Placebo
* Drug: Adalimumab


Participation Criteria
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Eligibility Criteria
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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; Participant tests negative for rheumatoid factor (RF) at the Screening Visit; Participant tests negative for anti-cyclic citrullinated peptide (CCP) antibodies at the Screening Visit; 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; 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sonelokimab dose regimen 1<br>Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 1 | Drug: Sonelokimab<br>* randomized treatment; parallel group<br>* Other names: M1095;|
| Experimental: sonelokimab dose regimen 2<br>Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 2 | Drug: Sonelokimab<br>* randomized treatment; parallel group<br>* Other names: M1095;|
| Experimental: sonelokimab dose regimen 3<br>Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 3 | Drug: Sonelokimab<br>* randomized treatment; parallel group<br>* Other names: M1095;|
| Placebo Comparator: Placebo<br>Subjects randomized to this arm will receive placebo | Drug: Placebo<br>* randomized treatment; parallel-group<br>|
| Active Comparator: adalimumab<br>Subjects randomized to this arm will receive adalimumab | Drug: Adalimumab<br>* randomized treatment; parallel-group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50) | Proportion of participants who achieve ACR50 compared with baseline | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate of participants achieving at least a 20% improvement in the American College of Rheumatology criteria (ACR20) | Proportion of participants who achieve ACR20 compared with baseline | Week 2, 4, 8, 12 | 
| Psoriasis Area and Severity Index (PASI) 90 | Proportion of participants who achieve PASI90 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline | Week 4, 8, 12 | 
| Response rate of participants achieving at least a 70% improvement in the American College of Rheumatology criteria | Proportion of participants who achieve ACR70 compared with baseline | Weeks 2, 4, 8, 12 | 
| Leeds Enthesitis Index (LEI) | Proportion of participants with resolution of enthesitis (LEI = 0) | Weeks 4, 8, 12 | 
| Leeds Dactylitis Index (LDI) | Change from baseline for Leeds Dactylitis Index | Weeks 4, 8, 12 | 
| Modified Nail Psoriasis Severity Index (mNAPSI) | Change from baseline for mNAPSI | Week 12 | 
| Psoriasis Area and Severity Index (PASI) 100 | Proportion of participants who achieve PASI100 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline | Weeks 4, 8, 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthritis, Psoriatic, Skin Diseases, Joint Diseases, Arthritis, Psoriasis