Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug
IZAR-1
A Phase 3, Parallel-group, Randomized, Double-blind, 3-arm, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis Who Are Naive to Biologic DMARDs
1 other identifier
interventional
960
19 countries
155
Brief Summary
This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2024
155 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedStudy Start
First participant enrolled
October 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 4, 2027
April 29, 2026
April 1, 2026
2.3 years
October 11, 2024
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
Proportion of participants achieving ACR50
Week 16
Secondary Outcomes (6)
Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20)
Week 16
Response rate of participants achieving Minimal Disease Activity (MDA)
Week 16
Health Assessment Questionnaire- Disability Index (HAQ-DI)
Week 16
Psoriasis Area and Severity Index (PASI90)
Week 16
Short- form-36 (SF-36) Physical Component Summary (PCS)
Week 16
- +1 more secondary outcomes
Study Arms (3)
sonelokimab dose with an induction regimen
EXPERIMENTALSubjects randomized to this arm will receive sonelokimab subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dosing starting at Week 8.
sonelokimab dose without an induction regimen
EXPERIMENTALSubjects randomized to this arm will receive sonelokimab subcutaneously every 4 weeks.
Placebo
PLACEBO COMPARATORSubjects randomized to this arm will receive placebo subcutaneously.
Interventions
Randomized treatment, parallel-group
Eligibility Criteria
You may qualify if:
- Participants must be ≥18 years of age .
- Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit.
- Participants have active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3).
- Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
- Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.
You may not qualify if:
- Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
- Participants with a diagnosis of inflammatory bowel disease.
- Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
- Participants who have an established diagnosis of arthritis mutilans.
- Previous exposure to sonelokimab.
- Participants who have ever received any biologic immunomodulating agents for PsA or PsO, whether investigational or approved.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (168)
Clinical Site
Avondale, Arizona, 85392, United States
Clinical Site
Chandler, Arizona, 85225, United States
Clinical Site
Flagstaff, Arizona, 86001, United States
Clinical Site
Mesa, Arizona, 85210, United States
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Phoenix, Arizona, 85032, United States
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Scottsdale, Arizona, 85260, United States
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Tucson, Arizona, 85748, United States
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San Diego, California, 92108, United States
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Upland, California, 91786, United States
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Avon Park, Florida, 33825, United States
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Clearwater, Florida, 33765, United States
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Hialeah, Florida, 33016, United States
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Tampa, Florida, 33607, United States
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Springfield, Illinois, 62702, United States
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Lake Charles, Louisiana, 70605, United States
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Baltimore, Maryland, 21224-6821, United States
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Grand Blanc, Michigan, 48439-2451, United States
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Leland, North Carolina, 28451, United States
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Salisbury, North Carolina, 28144, United States
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Statesville, North Carolina, 28625, United States
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Middleburg Heights, Ohio, 44130, United States
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Portland, Oregon, 97239, United States
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Memphis, Tennessee, 38119, United States
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Allen, Texas, 75013, United States
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Colleyville, Texas, 76034, United States
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Lubbock, Texas, 79424, United States
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Plano, Texas, 75024, United States
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Beckley, West Virginia, 25801, United States
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Pleven, 5800, Bulgaria
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Plovdiv, 4000, Bulgaria
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Plovdiv, 4001, Bulgaria
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Plovdiv, 4002, Bulgaria
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Plovdiv, 4004, Bulgaria
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Rousse, 7000, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, 1784, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Calgary, T2N 4L7, Canada
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Trois-Rivières, G9A 3X2, Canada
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Waterloo, N2J 1C4, Canada
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Winnipeg, R3A IM3, Canada
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Rijeka, 51 000, Croatia
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Zagreb, 10000, Croatia
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Brno, 63800, Czechia
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Břeclav, 690 02, Czechia
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Ostrava, 70200, Czechia
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Prague, 12850, Czechia
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Prague, 140 00, Czechia
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Prague, 14800, Czechia
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Prague, 150 00, Czechia
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Studénka, 742 13, Czechia
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Zlín, 760 01, Czechia
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Tallinn, 10117, Estonia
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Tallinn, 13419, Estonia
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Tartu, 50708, Estonia
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Kuopio, 70100, Finland
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Cahors, 46000, France
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Caluire-et-Cuire, 69300, France
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Échirolles, 38700, France
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Montpellier, 34295, France
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Narbonne, 11100, France
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Nice, 06001, France
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Rouen, 76031, France
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Tours, 37170, France
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Kutaisi, 4600, Georgia
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Tbilisi, 0102, Georgia
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Tbilisi, 0112, Georgia
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Tbilisi, 0141, Georgia
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Tbilisi, 0159, Georgia
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Tbilisi, 0160, Georgia
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Tbilisi, 0179, Georgia
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Tbilisi, 0180, Georgia
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Tbilisi, Georgia
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Bad Bentheim, 48455, Germany
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Berlin, 12161, Germany
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Berlin, 12203, Germany
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Berlin, 13125, Germany
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Erlangen, 91054, Germany
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Hamburg, 20095, Germany
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Herne, 44649, Germany
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Munich, 80639, Germany
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Munich, 81667, Germany
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München, 80336, Germany
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Athens, Attica, Greece
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Heraklion, 71110, Greece
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Budapest, 1023, Hungary
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Budapest, 1027, Hungary
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Budapest, 1036, Hungary
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Debrecen, H-4032, Hungary
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Gyula, 5700, Hungary
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Hódmezővásárhely, 6800, Hungary
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Kalocsa, 6300, Hungary
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Kistarcsa, 2143, Hungary
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Nyíregyháza, 4400, Hungary
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Székesfehérvár, 8000, Hungary
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Veszprém, 8200, Hungary
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Adazi, LV2164, Latvia
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Riga, LV-1001, Latvia
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Kaunas, 51270, Lithuania
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Šiauliai, 76231, Lithuania
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Bialystok, 15-879, Poland
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Bialystok, 15707, Poland
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Bydgoszcz, 85-065, Poland
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Bydgoszcz, 85-168, Poland
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Bytom, 41-902, Poland
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Częstochowa, 42-202, Poland
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Dąbrówka, 62-069, Poland
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Elblag, 82-300, Poland
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Gdynia, 81-384, Poland
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Krakow, 30-002, Poland
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Krakow, 30-149, Poland
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Krakow, 31-501, Poland
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Lodz, 91-363, Poland
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Lublin, 20-412, Poland
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Lublin, 20-607, Poland
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Nadarzyn, 05-830, Poland
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Nowa Sól, 67-100, Poland
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Olsztyn, 10-117, Poland
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Poznan, 60-218, Poland
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Poznan, 60-324, Poland
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Poznan, 60-446, Poland
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Poznan, 60-693, Poland
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Poznan, 61-113, Poland
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Poznan, 61-397, Poland
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Siedlce, 08-110, Poland
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Sochaczew, 96-500, Poland
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Swidnica, 58100, Poland
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Torun, 87-100, Poland
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Warsaw, 00-874, Poland
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Warsaw, 01-691, Poland
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Warsaw, 02-118, Poland
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Warsaw, 02-665, Poland
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Warsaw, 02-677, Poland
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Warsaw, 03-291, Poland
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Warsaw, 04-305, Poland
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Wołomin, 05-200, Poland
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Wroclaw, 51-685, Poland
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Wroclaw, 52-416, Poland
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Wroclaw, 53-673, Poland
Clinical SIte
Braga, 4700-000, Portugal
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Braga, 4710-243, Portugal
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Lisbon, 1500-458, Portugal
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Lisbon, 1649-035, Portugal
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Bucharest, 011172, Romania
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Bucharest, 012071, Romania
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Bucharest, 020475, Romania
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Bucharest, 030463, Romania
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Bucharest, 041303, Romania
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Timișoara, 300650, Romania
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Belgrade, 11000, Serbia
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Novi Sad, 21000, Serbia
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Košice, 04011, Slovakia
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Martin, 036 01, Slovakia
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Poprad, 058 01, Slovakia
Clinical Site
Rimavská Sobota, 979 01, Slovakia
Clinical Site
A Coruña, 15006, Spain
Clinical Site
Bilbao, 48013, Spain
Clinical Site
Castelló, 12004, Spain
Clinical Site
Madrid, 28003, Spain
Clinical Site
Madrid, 28046, Spain
Clinical Site
Málaga, 29009, Spain
Clinical Site
Sabadell, 08208, Spain
Clinical Site
Santiago de Compostela, 15702, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41009, Spain
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Seville, 41010, Spain
Clinical Site
Seville, 41013, Spain
Clinical Site
Valencia, 46007, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2024
First Posted
October 15, 2024
Study Start
October 15, 2024
Primary Completion (Estimated)
February 4, 2027
Study Completion (Estimated)
February 4, 2027
Last Updated
April 29, 2026
Record last verified: 2026-04