Psoriatic Arthritis Study of Izokibep

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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.

- Clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months prior to the 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 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.

- 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.

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05623345
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	ACELYRIN Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Apinya Lert, MD
Principal Investigator Affiliation	ACELYRIN Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Bulgaria, Canada, Czechia, Germany, Hungary, Poland, Puerto Rico, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Psoriatic Arthritis

Arms & Interventions

Arms

Experimental: Group 1

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

Experimental: Group 2

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

Experimental: Group 3

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

Experimental: Group 4

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

Interventions

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Clinical Research Site, Flagstaff, Arizona

Status

Recruiting

Address

Clinical Research Site

Flagstaff, Arizona, 86001

Site Contact

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