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

MoonLake Immunotherapeutics AG0 sites200 target enrollmentOctober 5, 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: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 5, 2022

End Date

TBD

Last Updated

last year

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;