Psoriatic ArthritisPhase 2/3NCT05623345
Psoriatic Arthritis Study of Izokibep
A Phase 2/3 study testing Izokibep in people with Psoriatic Arthritis, run by ACELYRIN Inc. at 71 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Izokibep
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 351 participants
- Where
- 71 sitesin 8 countries
- Study dates
- 21 Nov 2022to 8 Aug 2024
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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.
- Other Inclusions
- No known history of active tuberculosis (TB).
- Subject has a negative TB test at screening
Who cannot join
- 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:
- prolonged or recurrent diarrhea
- prolonged or recurrent abdominal pain
Show all 17Show fewer
- 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 locations and contacts
71 sites in 8 countries.
71 sites in 8 countries
United States40 sites
Clinical Research Site
Aventura, Florida, 33180
Clinical Research Site
Beckley, West Virginia, 25801
Clinical Research Site
Clearwater, Florida, 33765
Clinical Research Site
Colleyville, Texas, 76034
Clinical Research Site
Corvallis, Oregon, 97330
Clinical Research Site
Duncansville, Pennsylvania, 16635-8445
Clinical Research Site
Encino, California, 91436
Clinical Research Site
Flagstaff, Arizona, 86001
Clinical Research Site
Fountain Valley, California, 92708
Clinical Research Site
Fullerton, California, 92835
Clinical Research Site
Gainesville, Georgia, 30501
Clinical Research Site
Glendale, Arizona, 85306
Clinical Research Site
Grand Blanc, Michigan, 48439
Clinical Research Site
Hickory, North Carolina, 28602
Clinical Research Site
Hinsdale, Illinois, 60521
Clinical Research Site
Irving, Texas, 75013
Clinical Research Site
Jackson, Tennessee, 38305
Clinical Research Site
Jonesboro, Arkansas, 72401
Clinical Research Site
Kalispell, Montana, 59901
Clinical Research Site
Kissimmee, Florida, 34741
Clinical Research Site
Lexington, Kentucky, 40504
Clinical Research Site
Los Angeles, California, 90045
Clinical Research Site
Memphis, Tennessee, 38119
Clinical Research Site
Mesa, Arizona, 85210
Clinical Research Site
Mesquite, Texas, 75150
Clinical Research Site
Middleburg Heights, Ohio, 44130
Clinical Research Site
New Port Richey, Florida, 34652
Clinical Research Site
Orland Park, Illinois, 60467
Clinical Research Site
Ormond Beach, Florida, 32714
Clinical Research Site
Phoenix, Arizona, 85037
Clinical Research Site
Rancho Mirage, California, 92270
Clinical Research Site
Sacramento, California, 95815
Clinical Research Site
San Diego, California, 92128
Clinical Research Site
Santa Fe, New Mexico, 87505
Clinical Research Site
Santa Monica, California, 90404
Clinical Research Site
Sarasota, Florida, 34239-6900
Clinical Research Site
Seattle, Washington, 98122
Clinical Research Site
Skokie, Illinois, 60076
Clinical Research Site
Tucson, Arizona, 85704
Clinical Research Site
Upland, California, 91786
Poland9 sites
Clinical Research Site
Bialystok, 15-077
Clinical Research Site
Bialystok, 15-351
Clinical Research Site
Bydgoszcz, 85-650
Clinical Research Site
Elblag, 82-300
Clinical Research Site
Krakow, 30-510
Clinical Research Site
Poznan, 00-874
Clinical Research Site
Poznan, 61-113
Clinical Research Site
Warsaw, 00-874
Clinical Research Site
Warsaw, 02-691
Canada5 sites
Clinical Research Site
Québec, Quebec, G1V 3M7
Clinical Research Site
Saskatoon, Saskatchewan, S7H 5M7
Clinical Research Site
Sydney, Nova Scotia, B1S 3N1
Clinical Research Site
Trois-Rivières, Quebec, G8Z 1Y2
Clinical Research Site
Windsor, Ontario, N8X 1T3
Hungary5 sites
Clinical Research Site
Budapest, 1027
Clinical Research Site (003)
Budapest, 1036
Clinical Research Site
Kalocsa, 6300
Clinical Research Site
Székesfehérvár, 8000
Clinical Research Site
Veszprém, 8200
Bulgaria4 sites
Clinical Research Site
Burgas, 8000
Clinical Research Site
Pleven, 5808
Clinical Research Site
Rousse, 7012
Clinical Research Site
Sofia, 1303
Czechia3 sites
Clinical Research Site
Ostrava, 702 00
Clinical Research Site
Prague, 140 00
Clinical Research Site
Zlín, 760 01
Spain3 sites
Clinical Research Site
Alcobendas, 28100
Clinical Research Site
Santiago de Compostela, 15702
Clinical Research Site
Seville, 41010
Germany2 sites
Clinical Research Site
Frankfurt am Main, 60590
Clinical Research Site
Hamburg, 20095
About this study
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
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
- Being tested
- Izokibep, Placebo to izokibep
- Keywords
- psoriatic arthritis (PsA), psoriasis, inflammatory arthritis, enthesitis
- Medical subject headings
- Arthritis, Psoriatic, Psoriasis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IzokibepDrug
Biologic: IL-17A inhibitor
Form: Solution for injection
Route of administration: Subcutaneous (SC)
Placebo to izokibepDrug
Form: Solution for injection
Route of administration: Subcutaneous (SC)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Placebo from Day 1/Week 0 to Week 15, then izokibep from Week 16 to Week 51 Receives: Drug: Izokibep; Drug: Placebo to izokibep |
| Group 2 | Experimental | Izokibep Dose 1 from Day 1/Week 0 to Week 51 Receives: Drug: Izokibep |
| Group 3 | Experimental | Izokibep Dose 2 from Day 1/Week 0 to Week 51 Receives: Drug: Izokibep; Drug: Placebo to izokibep |
| Group 4 | Experimental | Izokibep Dose 3 from Day 1/Week 0 to Week 51 Receives: Drug: Izokibep; Drug: Placebo to izokibep |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
PASI is a tool used in clinical trials to measure the severity and extent of psoriasis. Scores range from a minimum of 0 to a maximum of 72, with higher scores indicating more severe disease.
Measured: Baseline and Week 16
Number of Participants With Baseline Enthesitis > 0 With Resolution of Enthesitis (Leeds Enthesitis Index [LEI] = 0) at Week 16
LEI is a clinical tool used to assess enthesitis in conditions like psoriatic arthritis and spondyloarthritis. It evaluates six sites: bilateral lateral epicondyles, medial femoral condyles, and achilles tendons. Each site is scored 0 (no pain) or 1 (pain on pressure), with a total score ranging from a minimum of 0 to a maximum of 6, where higher scores indicate more severe enthesitis.
Measured: Baseline and Week 16
Number of Participants Achieving Minimal Disease Activity (MDA) at Week 16
A participants was classified as being in MDA when at least five of the following seven criteria were met:
- Tender joint count based on 68 joints (TJC68) ≤ 1
- Swollen joint count based on 66 joints (SJC66) ≤ 1
- PASI ≤ 1 or BSA ≤ 3%
- Participant's Pain Assessment (Visual Analogue Scale [VAS]) ≤ 15 mm
- Participant's Global Activity VAS ≤ 20 mm (corresponding to participant's Global Assessment of Disease Activity)
- Health Assessment Questionnaire-Disability Index (HAQ-DI) ≤ 0.5
- Tender enthesitis points ≤ 1 out of 6 sites assessed by the LEI.
Measured: Week 16
Number of Participants Achieving 20% Improvement in ACR (ACR20) at Week 16
ACR20 is a clinical trial measure for PsA, indicating a 20% improvement in symptoms. To qualify, participants must show a 20% reduction in tender and swollen joint counts plus improvements in three of five additional criteria, including pain, global assessments, physical function, and inflammatory markers. ACR20 is binary-patients either meet it or not.
Measured: Week 16
Number of Participants With Baseline Psoriatic Arthritis Impact of Disease (PsAID) Score ≥ 3 With Improvement in PsAID Score at Week 16
The PsAID consists of nine items, each scored on a numeric rating scale (0-10), covering key aspects of disease burden, including pain, fatigue, skin problems, work/leisure activities, functional capacity, sleep disturbance, anxiety, coping, and social participation. The total score is calculated as a weighted sum of these individual items, with higher scores indicating a greater impact of the disease. The minimum score is 0 (no disease impact), while the maximum is 10 (worst possible disease impact). Reaching an improvement was considered an increase of 3 units from baseline score.
Measured: Week 16
Change in Physical Function as Assessed by HAQ-DI From Baseline to Week 16
The HAQ-DI consists of 20 questions divided into eight categories: dressing, arising, eating, walking, hygiene, reaching, grip, and other activities. Each item is scored on a scale from 0 to 3, where 0 = no difficulty, 1 = some difficulty, 2 = much difficulty, and 3 = unable to perform. The final HAQ-DI score is calculated as the average of the highest scores in each category, resulting in a range from 0 (no disability) to 3 (severe disability). Higher scores indicate greater functional impairment. A negative change indicates an improvement in functional impairment.
Measured: Baseline and Week 16
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and AE of Special Interest During Period 1
An AE was any untoward medical occurrence in a participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received study treatment. Clinically significant changes in vital signs, electrocardiograms and laboratory tests recorded after treatment administration were documented as TEAEs.
TEAEs were considered serious if they led to death, were life-threatening, required hospitalization or its prolongation, caused disability, resulted in congenital anomalies or were considered medically important.
The events of special interest monitored were : candida infection; inflammatory bowel disease; suicidal ideation; malignancies; major adverse cardiovascular and cerebrovascular events (cerebrovascular accident and transient ischemic attack, nonfatal myocardial infarction or unstable angina, cardiovascular death); tuberculosis; infections (opportunistic, serious, or fungal); cytopenia; systemic hypersensitivity reactions.
Measured: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation
Number of Participants Who Experienced TEAEs, Serious TEAEs and AE of Special Interest During Period 2
An AE was any untoward medical occurrence in a participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received study treatment. Clinically significant changes in vital signs, electrocardiograms and laboratory tests recorded after treatment administration were documented as TEAEs.
TEAEs were considered serious if they led to death, were life-threatening, required hospitalization or its prolongation, caused disability, resulted in congenital anomalies or were considered medically important.
The events of special interest monitored were : candida infection; inflammatory bowel disease; suicidal ideation; malignancies; major adverse cardiovascular and cerebrovascular events (cerebrovascular accident and transient ischemic attack, nonfatal myocardial infarction or unstable angina, cardiovascular death); tuberculosis; infections (opportunistic, serious, or fungal); cytopenia; systemic hypersensitivity reactions.
Measured: First dose of study treatment on or after Week 16 up to Week 55
Number of Participants With a Positive Treatment-emergent Anti-drug Antibody (ADA) Result
Blood samples were collected at different timepoints throughout the study. ADA is considered "Positive" if any titer value is available.
Measured: Baseline to Week 65
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start21 Nov 2022
- Primary completion30 Nov 2023
- Study completion8 Aug 2024
Why it stopped: Per our 13Aug24 press release, we announced discontinuation of internal development in this indication. This decision was not due to safety reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACELYRIN Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shepard Mpofu, MD, Clinical Development, Study director, ACELYRIN Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623345
- Sponsor's protocol ID
- 22104
- Other IDs
- 2022-501362-22
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2022
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05623345
- Acronym / sponsor ID
- 22104
- Conditions
- Psoriatic Arthritis
- Keywords
- psoriatic arthritis (PsA), psoriasis, inflammatory arthritis, enthesitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per our 13Aug24 press release, we announced discontinuation of internal development in this indication. This decision was not due to safety reasons.
- Enrolment
- 351 participants (actual)
- Lead sponsor
- ACELYRIN Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Izokibep, Drug: Placebo to izokibepPlacebo from Day 1/Week 0 to Week 15, then izokibep from Week 16 to Week 51 |
| Group 2 | Experimental | Drug: IzokibepIzokibep Dose 1 from Day 1/Week 0 to Week 51 |
| Group 3 | Experimental | Drug: Izokibep, Drug: Placebo to izokibepIzokibep Dose 2 from Day 1/Week 0 to Week 51 |
| Group 4 | Experimental | Drug: Izokibep, Drug: Placebo to izokibepIzokibep Dose 3 from Day 1/Week 0 to Week 51 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (17 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IzokibepBiologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC) | Drug | Group 1, Group 2, Group 3, Group 4 |
| Placebo to izokibepForm: Solution for injection Route of administration: Subcutaneous (SC) | Drug | Group 1, Group 3, Group 4 |
Primary outcome
Number of Participants Who Achieved 50% Improvement in American College of Rheumatology (ACR50) at Week 16
Time frame: 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.
9 secondary outcomes
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
Time frame: Baseline and Week 16
Number of Participants With Baseline Enthesitis > 0 With Resolution of Enthesitis (Leeds Enthesitis Index [LEI] = 0) at Week 16
Time frame: Baseline and Week 16
Number of Participants Achieving Minimal Disease Activity (MDA) at Week 16
Time frame: Week 16
Number of Participants Achieving 20% Improvement in ACR (ACR20) at Week 16
Time frame: Week 16
Number of Participants With Baseline Psoriatic Arthritis Impact of Disease (PsAID) Score ≥ 3 With Improvement in PsAID Score at Week 16
Time frame: Week 16
Change in Physical Function as Assessed by HAQ-DI From Baseline to Week 16
Time frame: Baseline and Week 16
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and AE of Special Interest During Period 1
Time frame: Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation
Number of Participants Who Experienced TEAEs, Serious TEAEs and AE of Special Interest During Period 2
Time frame: First dose of study treatment on or after Week 16 up to Week 55
Number of Participants With a Positive Treatment-emergent Anti-drug Antibody (ADA) Result
Time frame: Baseline to Week 65
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Psoriatic Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shepard Mpofu, MD, Clinical Development study director
ACELYRIN Inc.
71 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Izokibep in people with Psoriatic Arthritis, run by ACELYRIN Inc. at 71 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Poland, Canada, Hungary, Bulgaria and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Achieved 50% Improvement in American College of Rheumatology (ACR50) at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.