Psoriatic Arthritis Study of Izokibep

NCT05623345 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 221042022-501362-22
• Study Type: interventional
• Target: 351
• Locations: 8 countries
• Sites: 71

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.

Conditions

Psoriatic Arthritis

Keywords

psoriatic arthritis (PsA); psoriasis; inflammatory arthritis; enthesitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieved 50% Improvement in American College of Rheumatology (ACR50) at Week 16

  ACR50 is a clinical trial measure for PsA, indicating a 50% improvement in symptoms. To qualify, participants must show a 50% reduction in tender and swollen joint counts plus improvements in three of five additional criteria, including pain, global assessments, physical function, and inflammatory markers. ACR50 is binary-patients either meet it or not.

  Week 16

Secondary Outcomes (9)

• Number of Participants With Baseline ≥ 3% Body Surface Area (BSA) Psoriasis Who Achieved a 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI90) at Week 16

  Baseline and Week 16

• Number of Participants With Baseline Enthesitis > 0 With Resolution of Enthesitis (Leeds Enthesitis Index [LEI] = 0) at Week 16

  Baseline and Week 16

• Number of Participants Achieving Minimal Disease Activity (MDA) at Week 16

  Week 16

• Number of Participants Achieving 20% Improvement in ACR (ACR20) at Week 16

  Week 16

• Number of Participants With Baseline Psoriatic Arthritis Impact of Disease (PsAID) Score ≥ 3 With Improvement in PsAID Score at Week 16

  Week 16

Study Arms (4)

Group 1

EXPERIMENTAL

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

Drug: Izokibep; Drug: Placebo to izokibep

Group 2

EXPERIMENTAL

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

Drug: Izokibep

Group 3

EXPERIMENTAL

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

Drug: Izokibep; Drug: Placebo to izokibep

Group 4

EXPERIMENTAL

Izokibep Dose 3 from Day 1/Week 0 to Week 51

Drug: Izokibep; Drug: Placebo to izokibep

Interventions

Izokibep DRUG

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

Group 1; Group 2; Group 3; Group 4

Placebo to izokibep DRUG

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

Group 1; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• nonsteroidal anti-inflammatory drug (NSAID)
• conventional-synthetic disease-modifying anti-rheumatic drugs (csDMARD) (i.e. methotrexate, 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, 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.
• No known history of active tuberculosis (TB).

You may not qualify if:

• Disease-related Medical Conditions
• Any history or current confirmed diagnosis of inflammatory bowel disease (IBD)
• 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:
• prolonged or recurrent diarrhea
• prolonged or recurrent abdominal pain
• 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.

Sponsors & Collaborators

• ACELYRIN Inc.: lead

Study Sites (71)

Clinical Research Site

Flagstaff, Arizona, 86001, United States

Location

Clinical Research Site

Glendale, Arizona, 85306, United States

Location

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Mesa, Arizona, 85210, United States

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Phoenix, Arizona, 85037, United States

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Tucson, Arizona, 85704, United States

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Jonesboro, Arkansas, 72401, United States

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Encino, California, 91436, United States

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Fountain Valley, California, 92708, United States

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Fullerton, California, 92835, United States

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Los Angeles, California, 90045, United States

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Rancho Mirage, California, 92270, United States

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Sacramento, California, 95815, United States

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San Diego, California, 92128, United States

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Santa Monica, California, 90404, United States

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Upland, California, 91786, United States

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Aventura, Florida, 33180, United States

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Clearwater, Florida, 33765, United States

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Kissimmee, Florida, 34741, United States

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New Port Richey, Florida, 34652, United States

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Ormond Beach, Florida, 32714, United States

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Sarasota, Florida, 34239-6900, United States

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Gainesville, Georgia, 30501, United States

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Hinsdale, Illinois, 60521, United States

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Orland Park, Illinois, 60467, United States

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Skokie, Illinois, 60076, United States

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Lexington, Kentucky, 40504, United States

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Grand Blanc, Michigan, 48439, United States

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Kalispell, Montana, 59901, United States

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Santa Fe, New Mexico, 87505, United States

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Hickory, North Carolina, 28602, United States

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Middleburg Heights, Ohio, 44130, United States

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Corvallis, Oregon, 97330, United States

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Duncansville, Pennsylvania, 16635-8445, United States

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Jackson, Tennessee, 38305, United States

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Memphis, Tennessee, 38119, United States

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Colleyville, Texas, 76034, United States

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Irving, Texas, 75013, United States

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Mesquite, Texas, 75150, United States

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Seattle, Washington, 98122, United States

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Beckley, West Virginia, 25801, United States

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Burgas, 8000, Bulgaria

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Pleven, 5808, Bulgaria

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Rousse, 7012, Bulgaria

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Sofia, 1303, Bulgaria

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Sydney, Nova Scotia, B1S 3N1, Canada

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Windsor, Ontario, N8X 1T3, Canada

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Québec, Quebec, G1V 3M7, Canada

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Trois-Rivières, Quebec, G8Z 1Y2, Canada

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Saskatoon, Saskatchewan, S7H 5M7, Canada

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Ostrava, 702 00, Czechia

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Prague, 140 00, Czechia

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Zlín, 760 01, Czechia

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Frankfurt am Main, 60590, Germany

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Hamburg, 20095, Germany

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Budapest, 1027, Hungary

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Clinical Research Site (003)

Budapest, 1036, Hungary

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Kalocsa, 6300, Hungary

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Székesfehérvár, 8000, Hungary

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Veszprém, 8200, Hungary

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Bialystok, 15-077, Poland

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Bialystok, 15-351, Poland

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Bydgoszcz, 85-650, Poland

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Elblag, 82-300, Poland

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Krakow, 30-510, Poland

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Poznan, 00-874, Poland

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Poznan, 61-113, Poland

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Warsaw, 00-874, Poland

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Warsaw, 02-691, Poland

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Alcobendas, 28100, Spain

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Clinical Research Site

Santiago de Compostela, 15702, Spain

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Seville, 41010, Spain

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MeSH Terms

Conditions

Arthritis, Psoriatic; Psoriasis; Arthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Trials Information Desk
• Organization: Acelyrin Inc.

clinicaltrials@acelyrin.com

+18054564393

Study Officials

• Shepard Mpofu, MD, Clinical Development

  ACELYRIN Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 21, 2022
• Study Start: November 21, 2022
• Primary Completion: November 30, 2023
• Study Completion: August 8, 2024
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2024-11

Locations

CZ (3); DE (2); BU (4); CA (5); ES (3); US (40); PL (9); HU (5)