PSUMMIT-Jr

• Research type

  Research Study

• Full title

  A Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)

• IRAS ID

  1005896

• Contact name

  David Wright

• Contact email

  prderacta@prdgb.jnj.com

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2020-005503-40

• Clinicaltrials.gov Identifier

  NCT05083182

• Research summary

  Juvenile psoriatic arthritis (jPsA) is a complex, chronic, progressive, debilitating musculoskeletal disease with significant unmet medical need.
  This is a phase 3, open-label, multicentre study to see if the study medicines 'guselkumab' or 'ustekinuman' are safe and useful for treating patients with jPsA. About 80 children and adolescents (( ≥5 to <18 years) will be enrolled in this study worldwide. The expected duration of participation is 68 weeks.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  22/EE/0222

• Date of REC Opinion

  24 Nov 2022

• REC opinion

  Further Information Favourable Opinion