> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/evaluation-of-sonelokimab-in-patients-with-active-psoriatic-14254f1f-bd34-4d4a-a656-9b68ccf5ea5b > Record changed: 2026-11-04 # Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug NCT06641076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) Participants 960 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) Lead sponsor MoonLake Immunotherapeutics AG Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) Start date 2024-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) Number of sites 182 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Acronym** IZAR-1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Short title** Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) ## Dates **Completion date** 2027-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **First posted** 2024-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Registry last updated** 2026-10-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Primary completion date** 2026-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Start date** 2024-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) ## Size and sites **Participants** 960 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Planned participants** 960 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Number of sites** 182 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Lead sponsor** MoonLake Immunotherapeutics AG Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) ## Identifiers **Registry ID** NCT06641076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **ClinicalTrials.gov ID** NCT06641076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) ## Outcomes ### Primary outcomes 1. Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50) Timeframe: Week 16 Proportion of participants achieving ACR50 ### Secondary outcomes 1. Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20) Timeframe: Week 16 Proportion of participants achieving ACR20 2. Response rate of participants achieving Minimal Disease Activity (MDA) Timeframe: Week 16 Proportion of participants achieving MDA 3. Health Assessment Questionnaire- Disability Index (HAQ-DI) Timeframe: Week 16 Change in HAQ-DI from baseline 4. Psoriasis Area and Severity Index (PASI90) Timeframe: Week 16 Proportion of participants achieving a decrease of ≥90% in the PASI90 response at Week 16 in the subgroup of participants with psoriasis (PsO) involving ≥3% body surface area at baseline 5. Short- form-36 (SF-36) Physical Component Summary (PCS) Timeframe: Week 16 Change from Baseline in SF-36 PCS at Week 16 6. van der Heijde modified Total Sharp Score (vdHmTSS) Timeframe: Week 16 Change from Baseline to Week 16 in joint/bone structural damage (vdHmTSS) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Participants must be ≥18 years of age . 2. 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. 3. Participants have active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3). 4. Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO. 5. Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit. ### Exclusion criteria 1. Participants with a known hypersensitivity to sonelokimab or any of its excipients. 2. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA. 3. Participants with a diagnosis of inflammatory bowel disease. 4. Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit. 5. Participants who have an established diagnosis of arthritis mutilans. 6. Previous exposure to sonelokimab. 7. Participants who have ever received any biologic immunomodulating agents for PsA or PsO, whether investigational or approved. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) ## Sites - Clinical SiteAvondale, United States - Clinical SiteChandler, United States - Clinical SiteFlagstaff, United States - Clinical SiteMesa, United States - Clinical SitePhoenix, United States - Clinical SiteScottsdale, United States - Clinical SiteTucson, United States - Clinical SiteSan Diego, United States - Clinical SiteUpland, United States - Clinical SiteAvon Park, United States - Clinical SiteClearwater, United States - Clinical SiteHialeah, United States - Clinical SiteTampa, United States - Clinical SiteSpringfield, United States - Clinical SiteLake Charles, United States - Clinical SiteBaltimore, United States - Clinical SiteGrand Blanc, United States - Clinical SiteLeland, United States - Clinical SiteSalisbury, United States - Clinical SiteStatesville, United States - Clinical SiteMiddleburg Heights, United States - Clinical SitePortland, United States - Clinical SiteMemphis, United States - Clinical SiteAllen, United States - Clinical SiteColleyville, United States And 157 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641076) ## Related records ### Drugs (1) - [Sonelokimab](https://trialight.com/data/asset/sonelokimab-adbbf59a-55c7-5f7f-a428-64ceb12af05a.md) ### Lead sponsors (1) - [MoonLake Immunotherapeutics AG](https://trialight.com/data/company/moonlake-immunotherapeutics-ag-da0c6bc9-e1d7-4eb5-b43e-5f0341ac4aab.md) ### Conditions (1) - [Psoriatic arthritis](https://trialight.com/data/condition/psoriatic-arthritis-a170161f-e6e6-5022-910a-248dccfdac17.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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