Efficacy and Safety of ST-0529 in Subjects with Ulcerative Colitis

• Research type

  Research Study

• Full title

  A Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis.

• IRAS ID

  256447

• Contact name

  Tariq Iqbal

• Contact email

  Tariq.Iqbal@uhb.nhs.uk

• Sponsor organisation

  Sublimity Therapeutics (Hold Co) Ltd.

• Eudract number

  2018-003349-41

• Duration of Study in the UK

  1 years, 8 months, 17 days

• Research summary

  The intent of this phase 2 (exploratory) study is to assess the safety, efficacy and tolerability of different doses of ST-0529 in subjects with moderately to severely active ulcerative colitis (UC). The development of ST-0529 for the treatment of UC is based on an unmet need for alternative treatment options for subjects who have an inadequate clinical response to traditional UC therapies.
  Three ST-0529 dose strengths will be evaluated for 12 weeks compared to placebo. The active ingredient is cyclosporine, administered orally, that is formulated in a new way such that it bypasses systemic absorption and targets delivery of cyclosporine to the colon where it is needed.
  Patients 18 - 75 years of age with confirmed diagnoses of UC will be eligible to take part. The study will run globally in study centers across North America, Europe, (including the UK and Ireland) and the rest of the world. Approximately 280 eligible subjects will be randomized 1:1:1:1 to receive 18.75 mg, 37.5 mg or 75 mg of ST-0529 or matching placebo capsules BID for 12 weeks in the Treatment Period. A 4-week follow-up period is performed once the study medication is terminated. The anticipated duration of each subject’s participation in the CYC-202 study will be
  approximately 20 weeks from the initial Screening visit to the End-of-Study visit.

  The results from this trial will help identify the appropriate dose(s) for use in future phase 3 (confirmatory) clinical studies.

  During the study, subjects will provide the following samples (once they consented to taking part):
  - Blood for eligibility, safety and other exploratory assessments
  - Urine for safety analysis
  - Stool samples for efficacy and exploratory assessments

  Subject will undergo endoscopies and tissue biopsy samples will be collected for eligibility and efficacy assessments. At least 3 ECGs will be performed

  Subjects will also complete electronic diaries and Quality of Life Questionnaires during the study.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  19/EM/0062

• Date of REC Opinion

  28 Mar 2019

• REC opinion

  Further Information Favourable Opinion