Psoriatic Arthritis Study of Izokibep

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Izokibep is a potent and selective inhibitor of interleukin (IL)-17A that is being developed for treatment of psoriatic arthritis (PsA).

This study will evaluate the efficacy of izokibep in subjects with PsA.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ACELYRIN Inc.

Criteria

Inclusion Criteria:

General

• Subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

• Subject must be ≥18 (or the legal age of consent in the jurisdiction in which the study is taking place) and ≤75 years of age, at the time of signing the informed consent.

Type of Subject and Disease Characteristics

• Diagnosis of psoriatic arthritis (PsA) (by the Classification of Psoriatic Arthritis Criteria) for at least 6 months prior to first dose of study drug.

• Active PsA defined as ≥3 tender joints (based on 68 joint counts) and ≥3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits

• Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) negative at screening.

• Subject must have had an inadequate response to at least one of the following:

1. nonsteroidal anti-inflammatory drug (NSAID)

2. conventional-synthetic disease-modifying anti-rheumatic drugs (csDMARD) (i.e. MTX, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine A)

3. tumor necrosis factor-alpha inhibitor(s) (TNFi) (e.g. adalimumab, infliximab, etanercept, golimumab, certolizumab).

• For subjects using methotrexate, leflunomide, sulfasalazine, or apremilast, treated for ≥3 months and a stable dose (not to exceed 25 mg methotrexate per week, 20 mg leflunomide per day, sulfasalazine 3 g per day, or apremilast 60 mg per day) for ≥4 weeks prior to first dose of study drug.

• For subjects using corticosteroids, must have been on a stable dose and regimen and not to exceed 7.5 mg per day of prednisone (or other corticosteroid equivalent to 7.5 mg per day of prednisone) for ≥4 weeks prior to first dose of study drug.

• For subjects using NSAIDs, must have been on a stable dose and regimen for ≥2 weeks prior to first dose of study drug.

Other Inclusions

• No known history of active tuberculosis (TB).

• Subject has a negative TB test at screening

Exclusion Criteria:

Disease-related Medical Conditions

• Active inflammatory bowel disease (IBD) within 3 years.

• History of fibromyalgia or pain syndrome.

• Uncontrolled, clinically significant system disease

• Malignancy within 5 years

• Severe, uncontrolled, medically unstable mood disorder, such as severe depression.

• History or evidence of any clinically significant disorder (including psychiatric), condition, or disease that, in the opinion of the investigator, may pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

• Active infection or history of certain infections

• Candida infection requiring systemic treatment within 3 months prior to first dose of study drug.

• Tuberculosis or fungal infection seen on available chest x-ray taken within 3 months prior to first dose of study drug or at screening (Exception: documented evidence of completed treatment and clinically resolved).

• Known history of human immunodeficiency virus (HIV) or positive HIV test at screening.

Other protocol defined Inclusion/Exclusion criteria may apply