deltatrials
Recruiting INTERVENTIONAL NCT06641089

Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response (IZAR-2)

A Phase 3, Parallel-group, Randomized, Double-blind, 4-arm, Placebo-controlled, Multicenter Study With Risankizumab as Active Reference Arm, to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors

Sponsor: MoonLake Immunotherapeutics AG

Updated 7 times since 2024 Last updated: Apr 23, 2026 Started: Oct 15, 2024 Primary completion: Jan 15, 2027 Completion: Jan 15, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Arthritis, Psoriatic, this trial is actively recruiting participants. The trial is conducted by MoonLake Immunotherapeutics AG and has accumulated 7 data snapshots since 2024. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

M1095-PSA-302 is a Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm to investigate the efficacy and safety of sonelokimab 60 mg and 120 mg versus placebo in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

M1095-PSA-302 is a Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm to investigate the efficacy and safety of sonelokimab 60 mg and 120 mg versus placebo in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

Status Flow

~Nov 2024 – ~Jan 2025 · 2 months · monthly snapshotNot Yet Recruiting~Jan 2025 – ~Sep 2025 · 8 months · monthly snapshotRecruiting~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshotRecruiting~Dec 2025 – ~Jan 2026 · 31 days · monthly snapshot~Jan 2026 – ~Mar 2026 · 59 days · monthly snapshotRecruiting~Mar 2026 – ~May 2026 · 2 months · monthly snapshotRecruitingMay 4, 2026 – present · 56 days · daily APIRecruiting

Change History

7 versions recorded
  1. May 4, 2026 — Present [daily]

    Recruiting

    Phase: PHASE3None

  2. Mar 2026 — May 2026 [monthly]

    Recruiting PHASE3

  3. Jan 2026 — Mar 2026 [monthly]

    Recruiting PHASE3

  4. Dec 2025 — Jan 2026 [monthly]

    Recruiting PHASE3

  5. Sep 2025 — Dec 2025 [monthly]

    Recruiting PHASE3

Show 2 earlier versions
  1. Jan 2025 — Sep 2025 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  2. Nov 2024 — Jan 2025 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Oct 2024

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

Contact Information

Sponsor contact:
  • MoonLake Immunotherapeutics AG
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .