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

Phase 2

Completed

• Conditions: Arthritis, Psoriatic
• Interventions: Drug: Sonelokimab; Drug: Placebo; Drug: Adalimumab

• Registration Number: NCT05640245
• Lead Sponsor: MoonLake Immunotherapeutics AG

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.

Study Timeline

• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-11-28
• Study First Posted: 2022-12-07
• Study Start: 2022-12-13
• Primary Completion: 2023-09-05
• Status Verified: 2023-11
• Study Completion: 2024-01-15
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sonelokimab dose regimen 1	Sonelokimab	Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 1
sonelokimab dose regimen 2	Sonelokimab	Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 2
Placebo	Placebo	Subjects randomized to this arm will receive placebo
sonelokimab dose regimen 3	Sonelokimab	Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 3
adalimumab	Adalimumab	Subjects randomized to this arm will receive adalimumab

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (2)

Clinical SIte; 🇵🇱 Wrocław, Poland

Clinical Site; 🇪🇸 Sevilla, Spain