Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug

NCT06641076
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
960
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Lead sponsor
MoonLake Immunotherapeutics AG
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Start date
2024-10-15
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Number of sites
182
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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.
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Acronym
IZAR-1
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Short title
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-02-04
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First posted
2024-10-15
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Registry last updated
2026-10-09
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Primary completion date
2026-05-28
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Start date
2024-10-15
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Participants
960
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Participant count basis
Estimated
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Planned participants
960
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Protocol amendments
2
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Number of sites
182
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
MoonLake Immunotherapeutics AG
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06641076
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06641076
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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.

  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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)