UNIFI JR: Ustekinumab in Paediatric Ulcerative Colitis

• Research type

  Research Study

• Full title

  A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

• IRAS ID

  290822

• Contact name

  Rafeeq Muhammed

• Contact email

  rafeeq.muhammed@nhs.net

• Sponsor organisation

  Janssen-Cilag International N.V.

• Eudract number

  2019-004224-38

• Duration of Study in the UK

  4 years, 5 months, 31 days

• Research summary

  Ulcerative colitis is a chronic inflammatory bowel disorder of unknown cause, which can involve all areas of the large intestine/Colon. Ulcerative colitis is most commonly diagnosed in late adolescence and early adulthood, but a diagnosis may occur at any age. Clinically, patients with UC suffer from diarrhea, rectal bleeding, weight loss,
  abdominal pain, fever, and may also display problems outside of the colon, most commonly arthritis. There is a high
  unmet need for new treatment options in UC in paediatric populations, that are safe and effective, especially new therapies that can provide improved long-term efficacy (ie, sustained remission) over currently available therapies within the UK NHS hospitals.

  The UNIFI Jr study is looking to evaluate the effectiveness and safety of a treatment, Ustekinumab, in paediatric participants (aged 2 to <18 years of age) with Ulcerative Colitis (UC). Ustekinumab has been approved for the treatment of adults and pediatric patients with moderate to severe plaque psoriasis and adult patients with active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active Ulcerative colitis.

  Participants will be first screened for eligibility. They will then enter the Induction period where all participants will receive a single open-label IV administration of ustekinumab. Participants will then enter the maintenance period where all participants will be randomly assigned to receive ustekinumab (either every 8 or every 12 weeks) or a matched placebo to keep the blind. There will be a safety follow up visit 20 weeks after the last administration of study intervention.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  20/WM/0326

• Date of REC Opinion

  3 Feb 2021

• REC opinion

  Further Information Favourable Opinion