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

MoonLake Immunotherapeutics AG0 sites200 target enrollmentOctober 25, 2022

ConditionsActive Psoriatic Arthritis MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859 Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

DrugsHumira®

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Active Psoriatic Arthritis
Sponsor: MoonLake Immunotherapeutics AG
Enrollment: 200
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 25, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

MoonLake Immunotherapeutics AG

Eligibility Criteria

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 history of PsO; in either case, this diagnosis must have been confirmed by a dermatologist;
•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 at both the Screening Visit and study treatment initiation, a suitable candidate for treatment with adalimumab per approved local product information. If a chest X\-ray or computer tomography (CT) scan for tuberculosis (TB) screening is required per local guidance, the X\-ray or CT scan must be taken within 3 months prior to the Screening Visit;
•8\. Participant has had an inadequate response at the Screening Visit (lack of efficacy after \=12\-week duration of therapy) to previous or current treatment with \=1 non\-biologic disease\-modifying anti\-rheumatic drug (DMARD) at maximally tolerated dose, or participant has an intolerance to or contraindication for DMARDs as defined by the investigator;
•9\. If the participant is female, she must be of non\-childbearing potential or – if of childbearing potential, participant must agree to use highly effective methods of contraception.
•10\. Women of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at the Screening Visit and a negative urine pregnancy test at Week 0/Day 1 prior to the first administration of study treatment;

Exclusion Criteria

•1\. Known hypersensitivity to sonelokimab, adalimumab or any of its excipients;
•2\. Subjects who currently uses or plans to use 1 or more prohibited treatments specified in this protocol. Prohibited treatments and washout periods detailed in the protocol must be adhered to;
•3\. Subjects who has previously failed on anti (IL)\-17 therapy, after at least 16 weeks of treatment; or is unsuitable for anti\-IL\-17 therapy for any reason according to the investigator’s discretion;
•4\. Subjects who has previously failed on anti\-tumor necrosis factor alpha (TNFa) therapy, after at least 16 weeks of treatment; or is unsuitable for anti\-TNFa therapy for any other reason according to the investigator’s discretion;
•5\. Subjects who has had previous exposure to more than 2 biologic agents of any type to treat PsA prior to the Screening Visit, including but not limited to IL\-17 inhibitors, IL\-23 inhibitors, TNFa inhibitors, etc;
•6\. Subjects who has a diagnosis of chronic inflammatory conditions other than PsO or PsA, including but not limited to rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus, Crohn’s disease, or ulcerative colitis;
•7\. Has a diagnosis of arthritis mutilans;
•8\. Has an active infection or history of infections, as defined in the protocol;
•9\. Subjects who received a live (including attenuated) vaccination within 8 weeks before study treatment initiation, or planned to receive a live vaccination during the study and up to at least 12 weeks after the last dose of study treatment. Examples of restricted vaccinations provided in the protocol;
•10\. Subjects who received a Bacillus Calmette\-Guérin (BCG) vaccination within 1 year before study treatment initiation;