Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
351 participants
INTERVENTIONAL
2022-11-21
2024-08-08
Brief Summary
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This study will evaluate the efficacy of izokibep in subjects with PsA.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1
Placebo from Day 1/Week 0 to Week 15, then izokibep from Week 16 to Week 51
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)
Group 2
Izokibep Dose 1 from Day 1/Week 0 to Week 51
Izokibep
Biologic: IL-17A inhibitor
Form: Solution for injection
Route of administration: Subcutaneous (SC)
Group 3
Izokibep Dose 2 from Day 1/Week 0 to Week 51
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)
Group 4
Izokibep Dose 3 from Day 1/Week 0 to Week 51
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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ACELYRIN Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shepard Mpofu, MD, Clinical Development
Role: STUDY_DIRECTOR
ACELYRIN Inc.
Locations
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Clinical Research Site
New Port Richey, Florida, United States
Clinical Research Site
Ormond Beach, Florida, United States
Clinical Research Site
Sarasota, Florida, United States
Clinical Research Site
Gainesville, Georgia, United States
Clinical Research Site
Hinsdale, Illinois, United States
Clinical Research Site
Orland Park, Illinois, United States
Clinical Research Site
Skokie, Illinois, United States
Clinical Research Site
Lexington, Kentucky, United States
Clinical Research Site
Grand Blanc, Michigan, United States
Clinical Research Site
Kalispell, Montana, United States
Clinical Research Site
Santa Fe, New Mexico, United States
Clinical Research Site
Hickory, North Carolina, United States
Clinical Research Site
Middleburg Heights, Ohio, United States
Clinical Research Site
Corvallis, Oregon, United States
Clinical Research Site
Duncansville, Pennsylvania, United States
Clinical Research Site
Jackson, Tennessee, United States
Clinical Research Site
Memphis, Tennessee, United States
Clinical Research Site
Colleyville, Texas, United States
Clinical Research Site
Irving, Texas, United States
Clinical Research Site
Mesquite, Texas, United States
Clinical Research Site
Seattle, Washington, United States
Clinical Research Site
Beckley, West Virginia, United States
Clinical Research Site
Burgas, , Bulgaria
Clinical Research Site
Pleven, , Bulgaria
Clinical Research Site
Rousse, , Bulgaria
Clinical Research Site
Sofia, , Bulgaria
Clinical Research Site
Sydney, Nova Scotia, Canada
Clinical Research Site
Windsor, Ontario, Canada
Clinical Research Site
Québec, Quebec, Canada
Clinical Research Site
Trois-Rivières, Quebec, Canada
Clinical Research Site
Saskatoon, Saskatchewan, Canada
Clinical Research Site
Ostrava, , Czechia
Clinical Research Site
Prague, , Czechia
Clinical Research Site
Zlín, , Czechia
Clinical Research Site
Frankfurt am Main, , Germany
Clinical Research Site
Hamburg, , Germany
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, , Hungary
Clinical Research Site
Bialystok, , Poland
Clinical Research Site
Bialystok, , Poland
Clinical Research Site
Bydgoszcz, , Poland
Clinical Research Site
Elblag, , Poland
Clinical Research Site
Krakow, , Poland
Clinical Research Site
Poznan, , Poland
Clinical Research Site
Poznan, , Poland
Clinical Research Site
Warsaw, , Poland
Clinical Research Site
Warsaw, , Poland
Clinical Research Site
Alcobendas, , Spain
Clinical Research Site
Santiago de Compostela, , Spain
Clinical Research Site
Seville, , Spain
Clinical Research Site
Flagstaff, Arizona, United States
Clinical Research Site
Glendale, Arizona, United States
Clinical Research Site
Mesa, Arizona, United States
Clinical Research Site
Phoenix, Arizona, United States
Clinical Research Site
Tucson, Arizona, United States
Clinical Research Site
Jonesboro, Arkansas, United States
Clinical Research Site
Encino, California, United States
Clinical Research Site
Fountain Valley, California, United States
Clinical Research Site
Fullerton, California, United States
Clinical Research Site
Los Angeles, California, 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 Monica, California, United States
Clinical Research Site
Upland, California, United States
Clinical Research Site
Aventura, Florida, United States
Clinical Research Site
Clearwater, Florida, United States
Clinical Research Site
Kissimmee, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2022-501362-22
Identifier Type: OTHER
Identifier Source: secondary_id
22104
Identifier Type: -
Identifier Source: org_study_id
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