Psoriatic Arthritis Study of Izokibep

Sponsor

ACELYRIN Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05623345

Collaborator

(none)

300

Enrollment

Locations

Arms

24.3

Anticipated Duration (Months)

37.5

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis	Drug: Izokibep Drug: Placebo to izokibep	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2b/3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Active Psoriatic Arthritis

Actual Study Start Date :

Nov 21, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Placebo from Day 1/Week 0 to Week 15, then izokibep from Week 16 to Week 51	Drug: Izokibep Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC) Drug: Placebo to izokibep Form: Solution for injection Route of administration: Subcutaneous (SC)
Experimental: Group 2 Izokibep Dose 1 from Day 1/Week 0 to Week 51	Drug: Izokibep Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)
Experimental: Group 3 Izokibep Dose 2 from Day 1/Week 0 to Week 51	Drug: Izokibep Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC) Drug: Placebo to izokibep Form: Solution for injection Route of administration: Subcutaneous (SC)

Arm

Intervention/Treatment

Experimental: Group 1

Placebo from Day 1/Week 0 to Week 15, then izokibep from Week 16 to Week 51

Drug: Izokibep

Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)

Drug: Placebo to izokibep

Form: Solution for injection Route of administration: Subcutaneous (SC)

Experimental: Group 2

Izokibep Dose 1 from Day 1/Week 0 to Week 51

Drug: Izokibep

Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)

Experimental: Group 3

Izokibep Dose 2 from Day 1/Week 0 to Week 51

Drug: Izokibep

Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)

Drug: Placebo to izokibep

Form: Solution for injection Route of administration: Subcutaneous (SC)

Outcome Measures

Primary Outcome Measures

Proportion of subjects achieving 50% improvement in American College of Rheumatology (ACR50) [Week 16]

Secondary Outcome Measures

Proportion of subjects with resolution of enthesitis Leeds Enthesitis Index in subjects with enthesitis (LEI>0) at baseline [Week 16]
Proportion of subjects achieving an improvement in Psoriatic Arthritis Impact of Disease (PsAID) of at least 3 units at Week 16 compared to baseline in subjects with PsAID ≥3 at baseline [Week 16]
Proportion of subjects achieving 90% or greater reduction in Psoriasis Area and Severity Index (PASI) score from baseline (PASI90) at Week 16 in subjects with ≥3% body surface area (BSA) psoriasis at baseline [Week 16]
Change in physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI) change from baseline to Week 16 [Week 16]
Proportion of subjects achieving 20% improvement in American College of Rheumatology (ACR20) [Week 16]
Incidence of treatment-emergent adverse events (TEAEs) [Day 1 to end of treatment; Up to 52 weeks (±3 days)]
Incidence of events of interest [Screening to Safety Follow-up; Up to 59 weeks (±5 days)]
Incidence of serious adverse events (SAEs) [Screening to Safety Follow-up; Up to 59 weeks (±5 days)]
Incidence of clinically significant changes in laboratory values [Screening to End of Study; Up to 65 weeks (±5 days)]
Incidence of clinically significant changes in vital signs [Screening to Safety Follow-up; Up to 59 weeks (±5 days)]
Incidence of treatment-emergent anti-drug antibodies (ADAs) [Day 1 to End of Study; Up to 65 weeks (±5 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Site	Palm Desert	California	United States	92260
2	Clinical Research Site	Sarasota	Florida	United States	34239-6900
3	Clinical Research Site	Lexington	Kentucky	United States	40504
4	Clinical Research Site	Cumberland	Maryland	United States	21502
5	Clinical Research Site	Grand Blanc	Michigan	United States	48439
6	Clinical Research Site	Middleburg Heights	Ohio	United States	44130
7	Clinical Research Site	Duncansville	Pennsylvania	United States	16635-8445
8	Clinical Research Site	Beckley	West Virginia	United States	25801