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Interleukin-17A Inhibitor
Izokibep for Psoriatic Arthritis
Phase 2 & 3
Waitlist Available
Research Sponsored by ACELYRIN Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to end of study; up to 65 weeks (±5 days)
Awards & highlights
Study Summary
This trial will test a new drug to treat psoriatic arthritis, an inflammatory joint condition.
Who is the study for?
Adults aged 18-75 with psoriatic arthritis diagnosed at least 6 months ago, who haven't responded well to certain drugs like NSAIDs or TNF inhibitors. They must not have severe depression, active infections, inflammatory bowel disease, fibromyalgia, other types of arthritis diagnosed before age 17, uncontrolled diseases, TB or fungal infections in recent chest x-rays, HIV positive status or a history of cancer within the last five years.Check my eligibility
What is being tested?
The trial is testing Izokibep's effectiveness for treating psoriatic arthritis compared to a placebo. Izokibep is designed to block interleukin (IL)-17A which plays a role in inflammation and is believed to contribute to PsA symptoms.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system suppression such as increased risk of infection. Specific side effects are not listed but could be similar to those seen with other IL-17A inhibitors like injection site reactions or allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have active Psoriatic Arthritis with at least 3 tender and 3 swollen joints.
Select...
I have tried at least one common arthritis treatment without enough improvement.
Select...
I am between 18 and 75 years old and can legally consent.
Select...
I have never had active tuberculosis.
Select...
I am between 18 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to end of study; up to 65 weeks (±5 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to end of study; up to 65 weeks (±5 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects achieving 50% improvement in American College of Rheumatology (ACR50)
Secondary outcome measures
Change in physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI) change from baseline to Week 16
Incidence of clinically significant changes in laboratory values
Incidence of clinically significant changes in vital signs
+9 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Group 4Experimental Treatment2 Interventions
Izokibep Dose 3 from Day 1/Week 0 to Week 51
Group II: Group 3Experimental Treatment2 Interventions
Izokibep Dose 2 from Day 1/Week 0 to Week 51
Group III: Group 2Experimental Treatment1 Intervention
Izokibep Dose 1 from Day 1/Week 0 to Week 51
Group IV: Group 1Experimental Treatment2 Interventions
Placebo from Day 1/Week 0 to Week 15, then izokibep from Week 16 to Week 51
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Izokibep
2022
Completed Phase 2
~190
Placebo to izokibep
2022
Completed Phase 2
~180
Find a Location
Who is running the clinical trial?
ACELYRIN Inc.Lead Sponsor
8 Previous Clinical Trials
707 Total Patients Enrolled
1 Trials studying Psoriatic Arthritis
129 Patients Enrolled for Psoriatic Arthritis
Myreen Tomas, MDStudy DirectorACELYRIN Inc.
1 Previous Clinical Trials
129 Total Patients Enrolled
1 Trials studying Psoriatic Arthritis
129 Patients Enrolled for Psoriatic Arthritis
Apinya Lert, MDStudy DirectorACELYRIN Inc.
1 Previous Clinical Trials
129 Total Patients Enrolled
1 Trials studying Psoriatic Arthritis
129 Patients Enrolled for Psoriatic Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious illness that is not under control.My arthritis pain might affect my participation in the study.I have been diagnosed with psoriatic arthritis for at least 6 months and meet the CASPAR criteria.I don't have any health conditions that could risk my safety in the study.I have been on a stable dose of corticosteroids, not exceeding 7.5 mg of prednisone daily, for at least 4 weeks.I have had fibromyalgia, arthritis before 17, or have inflammatory joint disease (not PsA).I have or might have inflammatory bowel disease, indicated by high fecal calprotectin levels.Your blood test results for rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) are negative.I have active Psoriatic Arthritis with at least 3 tender and 3 swollen joints.I have tried at least one common arthritis treatment without enough improvement.I have been diagnosed with psoriatic arthritis for at least 6 months.I am between 18 and 75 years old and can legally consent.It seems like there might be a mistake here. "General" doesn't provide specific information about the exclusion criteria. If you have more details or if there's a specific criterion you'd like me to summarize, please let me know!My disease type and characteristics match the study requirements.I have been on a stable dose of NSAIDs or low potency opioids for at least 2 weeks.You tested negative for tuberculosis before joining the study.I have never had active tuberculosis.I do not have severe depression or similar conditions that are not under control.I currently have an infection or have had serious infections in the past.I have been on a stable dose of specific arthritis medications for at least 4 weeks.You have tuberculosis or a fungal infection in your chest, as seen on a recent chest x-ray.Your rheumatoid factor and anti-cyclic citrullinated peptide tests are negative.I have HIV or tested positive for HIV.I have not responded well or cannot take certain arthritis medications.I was diagnosed with cancer within the last 5 years.I have had a yeast infection treated with medication in the last 3 months.I am between 18 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Group 3
- Group 2: Group 4
- Group 3: Group 1
- Group 4: Group 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the age limit for inclusion in this experimental research?
"As outlined in the eligibility criteria, individuals participating have to be between 18 and 75 years old. For those that do not meet this requirement, there are 53 trials for minors or 318 studies catered towards seniors."
Answered by AI
Are there opportunities for enrollment in this experiment still available?
"Information on clinicaltrials.gov attests that this medical study is actively looking for participants. It was first posted at the start of November 2022 and the last update to its listing was made in mid-November."
Answered by AI
Am I eligible to become a subject in this medical experiment?
"This trial is seeking to enrol up to 300 individuals who suffer from psoriatic arthritis and are within the age demographic of 18-75."
Answered by AI
How many applicants have been accepted to participate in this experiment?
"Affirmative. According to the details published on clinicaltrials.gov, this medical experiment, which first appeared online November 1st 2022, is currently in search of volunteers. 300 individuals are being sought from 3 separate locations."
Answered by AI
Who else is applying?
What state do they live in?
Kentucky
What site did they apply to?
Clinical Research Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
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