IZAR-OLE

• Research type

  Research Study

• Full title

  A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with psoriatic arthritis (PsA)

• IRAS ID

  1012822

• Contact name

  Kristian Reich

• Contact email

  ClinicalTrials@moonlaketx.com

• Sponsor organisation

  MoonLake Immunotherapeutics AG

• Clinicaltrials.gov Identifier

  NCT07223138

• Research summary

  Psoriatic arthritis (PsA) is a chronic inflammatory arthritis associated with psoriasis that primarily affects the peripheral joints, skin and nails. The symptom burden of PsA and associated comorbidities has a substantial negative impact on patient quality of life. Treatment options are available but may not fully work for everyone and there is a significant unmet need for new therapies.

  Sonelokimab is a research drug under investigation for the treatment of PsA. Sonelokimab is a nanobody. Nanobody molecules are a type of miniature antibody that recognise other proteins in the body and specifically bind to them. Sonelokimab works by blocking two molecules in the body that are associated with inflammation: interleukin 17A and interleukin 17F, which are present at increased levels in PsA.

  The purpose of this extension study is to evaluate whether the research drug sonelokimab is safe, well tolerated and effective over a longer period in people with PsA who were previously enrolled in the parent phase 3 studies for sonelokimab (M1095-PSA-301 or M1095-PSA-302). Sonelokimab will be administered by subcutaneous (SC) injection by the Molly autoinjector device. Following successful training and supervision, participants (or someone assisting them) will be asked to use the autoinjector device to self-administer doses of sonelokimab SC at home and at the study centre.

  Up to 1560 participants may be enrolled.

  Study phases:
  • Screening – assessments performed at the end of treatment visit of the parental study
  • Treatment phase – all participants will receive sonelokimab SC every 4 weeks for up to 48 weeks
  • Safety follow-up visit – 8 weeks after last dose of study treatment

  Study procedures will include weight, vital signs, physical exams, blood and urine tests, ECGs, diaries and questionnaires.

• REC name

  Wales REC 3

• REC reference

  26/WA/0007

• Date of REC Opinion

  30 Jan 2026

• REC opinion

  Further Information Favourable Opinion