Psoriatic Arthritis Study of Izokibep

Psoriatic Arthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05623345
• Other study ID #: 22104
• Secondary ID: 2022-501362-22
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: November 21, 2022
• Est. completion date: November 7, 2024

Study information

• Verified date: February 2024
• Source: ACELYRIN Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 351
• Est. completion date: November 7, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

• Clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months prior to first dose of study drug and fulfillment of the ClASsification for Psoriatic ARthritis (CASPAR) criteria at Screening.

• 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, intolerance, or contraindication to at least one of the following:

1. nonsteroidal anti-inflammatory drug (NSAID)

2. conventional-synthetic disease-modifying anti-rheumatic drugs (csDMARD) (i.e. methotrexate, 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, hydroxychloroquine, 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, hydroxychloroquine 400 mg 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.

• Subjects using NSAIDs, or low potency opioid medications (tramadol, paracetamol in combination with hydrocodone or with codeine) 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

• Any history or current confirmed diagnosis of inflammatory bowel disease (IBD)

OR

• Any of the following symptoms (of unknown etiology) or any signs or symptoms within the last year that in the opinion of the Investigator may be suggestive of IBD, with fecal calprotectin = 500 µg/g; OR if fecal calprotectin >150 to <500 µg/g without confirmed approval from a GI consult that an IBD diagnosis is clinically unlikely when the following clinical signs and symptoms are present:

1. prolonged or recurrent diarrhea

2. prolonged or recurrent abdominal pain

3. blood in stool

• History of fibromyalgia, or any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than psoriatic arthritis (PsA) (including, but not limited to rheumatoid arthritis, gout, connective tissue diseases). Prior history of axial spondyloarthritis or fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis was made incorrectly. Prior history of reactive arthritis or axial spondyloarthritis is permitted if an additional diagnosis of PsA is made. Chronic osteoarthritis symptoms that in the Investigator's opinion may interfere with study assessments.

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Izokibep
Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)
• Placebo to izokibep
Form: Solution for injection Route of administration: Subcutaneous (SC)

Locations

Country	Name	City	State
Bulgaria	Clinical Research Site	Bourgas
Bulgaria	Clinical Research Site	Pleven
Bulgaria	Clinical Research Site	Ruse
Bulgaria	Clinical Research Site	Sofia
Canada	Clinical Research Site	Québec	Quebec
Canada	Clinical Research Site	Saskatoon	Saskatchewan
Canada	Clinical Research Site	Sydney	Nova Scotia
Canada	Clinical Research Site	Trois-Rivières	Quebec
Canada	Clinical Research Site	Windsor	Ontario
Czechia	Clinical Research Site	Ostrava
Czechia	Clinical Research Site	Praha
Czechia	Clinical Research Site	Zlin
Germany	Clinical Research Site	Frankfurt am Main
Germany	Clinical Research Site	Hamburg
Hungary	Clinical Research Site	Budapest
Hungary	Clinical Research Site (003)	Budapest
Hungary	Clinical Research Site	Kalocsa
Hungary	Clinical Research Site	Székesfehérvár
Hungary	Clinical Research Site	Veszprém
Poland	Clinical Research Site	Bialystok
Poland	Clinical Research Site	Bialystok
Poland	Clinical Research Site	Bydgoszcz
Poland	Clinical Research Site	Elblag
Poland	Clinical Research Site	Kraków
Poland	Clinical Research Site	Poznan
Poland	Clinical Research Site	Poznan
Poland	Clinical Research Site	Warszawa
Poland	Clinical Research Site	Warszawa
Spain	Clinical Research Site	Alcobendas
Spain	Clinical Research Site	Santiago De Compostela
Spain	Clinical Research Site	Sevilla
United States	Clinical Research Site	Aventura	Florida
United States	Clinical Research Site	Beckley	West Virginia
United States	Clinical Research Site	Clearwater	Florida
United States	Clinical Research Site	Colleyville	Texas
United States	Clinical Research Site	Corvallis	Oregon
United States	Clinical Research Site	Duncansville	Pennsylvania
United States	Clinical Research Site	Encino	California
United States	Clinical Research Site	Flagstaff	Arizona
United States	Clinical Research Site	Fountain Valley	California
United States	Clinical Research Site	Fullerton	California
United States	Clinical Research Site	Gainesville	Georgia
United States	Clinical Research Site	Glendale	Arizona
United States	Clinical Research Site	Grand Blanc	Michigan
United States	Clinical Research Site	Hickory	North Carolina
United States	Clinical Research Site	Hinsdale	Illinois
United States	Clinical Research Site	Irving	Texas
United States	Clinical Research Site	Jackson	Tennessee
United States	Clinical Research Site	Jonesboro	Arkansas
United States	Clinical Research Site	Kalispell	Montana
United States	Clinical Research Site	Kissimmee	Florida
United States	Clinical Research Site	Lexington	Kentucky
United States	Clinical Research Site	Los Angeles	California
United States	Clinical Research Site	Memphis	Tennessee
United States	Clinical Research Site	Mesa	Arizona
United States	Clinical Research Site	Mesquite	Texas
United States	Clinical Research Site	Middleburg Heights	Ohio
United States	Clinical Research Site	New Port Richey	Florida
United States	Clinical Research Site	Orland Park	Illinois
United States	Clinical Research Site	Ormond Beach	Florida
United States	Clinical Research Site	Phoenix	Arizona
United States	Clinical Research Site	Rancho Mirage	California
United States	Clinical Research Site	Sacramento	California
United States	Clinical Research Site	San Diego	California
United States	Clinical Research Site	Santa Fe	New Mexico
United States	Clinical Research Site	Santa Monica	California
United States	Clinical Research Site	Sarasota	Florida
United States	Clinical Research Site	Seattle	Washington
United States	Clinical Research Site	Skokie	Illinois
United States	Clinical Research Site	Tucson	Arizona
United States	Clinical Research Site	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
ACELYRIN Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  Germany,  Hungary,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving 50% improvement in American College of Rheumatology (ACR50)		Week 16
Secondary	Proportion of subjects with resolution of enthesitis Leeds Enthesitis Index in subjects with enthesitis (LEI>0) at baseline		Week 16
Secondary	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
Secondary	Proportion of subjects achieving minimal disease activity (MDA)		Week 16
Secondary	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
Secondary	Change in physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI) change from baseline to Week 16		Week 16
Secondary	Proportion of subjects achieving 20% improvement in American College of Rheumatology (ACR20)		Week 16
Secondary	Incidence of treatment-emergent adverse events (TEAEs)		Day 1 to end of treatment; Up to 52 weeks (±3 days)
Secondary	Incidence of events of interest		Screening to Safety Follow-up; Up to 59 weeks (±5 days)
Secondary	Incidence of serious adverse events (SAEs)		Screening to Safety Follow-up; Up to 59 weeks (±5 days)
Secondary	Incidence of clinically significant changes in laboratory values		Screening to End of Study; Up to 65 weeks (±5 days)
Secondary	Incidence of clinically significant changes in vital signs		Screening to Safety Follow-up; Up to 59 weeks (±5 days)
Secondary	Incidence of treatment-emergent anti-drug antibodies (ADAs)		Day 1 to End of Study; Up to 65 weeks (±5 days)