A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.

• ClinicalTrials.gov Identifier: NCT03675477
• Recruitment Status: Recruiting
• First Posted: September 18, 2018
• Last Update Posted: August 19, 2019
• Sponsor: Reistone Biopharma Company Limited
• Information provided by (Responsible Party): Reistone Biopharma Company Limited

Tracking Information

• First Submitted Date: September 16, 2018
• First Posted Date: September 18, 2018
• Last Update Posted Date: August 19, 2019
• Actual Study Start Date: April 13, 2019
• Estimated Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 16, 2018)

The percentage of subject achieve clinical response at week 8 [ Time Frame: Week 8 ]

Clinical response is defined as decrease from baseline in 9-point modified Mayo score of at least 2 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03675477 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: September 16, 2018)

• The percentage of subjects achieve clinical remission [ Time Frame: Week 8 ]
  The percentage of subjects achieve clinical remission per 9-point modified Mayo score at week 8, where stool frequency subscore ≤ 1, rectal bleeding subscore of 0, and endoscopic subscore ≤ 1
• The percentage of subjects achieve clinical remission at week 8 [ Time Frame: Week 8 ]
  The percentage of subjects achieve clinical remission at week 8 as per total Mayo score of 2 points or lower ≤2, with no individual subscore exceeding 1point and a rectal bleeding subscore of 0.
• The percentage of subjects achieve endoscopic remission (mucosal healing) at week 8, defined by Mayo endoscopic subscore ≤ 1 point. [ Time Frame: Week 8 ]
  The percentage of subjects achieve endoscopic remission (mucosal healing) at week 8, defined by Mayo endoscopic subscore ≤ 1 point.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.
• Official Title: A Phase II Randomized, Placebo Controlled, Double-blind, 4 Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Ulcerative Colitis.

Brief Summary

The proposed study is a randomized, double-blind,placebo-controlled, multi-center phase II study to investigatethe safety and efficacy of SHR0302 in patients with moderate to severe activeulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 andtime needed in inducing clinical response in active ulcerative colitispatients.

This is an 8+8 weeksstudy, in which participants who complete the first 8 weeks treatment phase, will have the option to enter a blinded activearms 8-week extension phase. Early withdrawn subjects during the first treatment phasecannot enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 18weeks.

SHR0302 is a JAK1 inhibitor, capable of blocking JAK-STATs pathway and control inflammation. Therefore it has the potential to be a treatment for UC.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Ulcerative Colitis

Intervention

• Drug: SHR0302
  The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
• Drug: Placebos
  Placebo Oral Tablet

Study Arms

• Active Comparator: SHR0302 dose A
  Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 16.
  Intervention: Drug: SHR0302
• Active Comparator: SHR0302 dose B
  Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 16.
  Intervention: Drug: SHR0302
• Active Comparator: SHR0302 dose C
  Participants randomized in this arm will receive dose D of SHR0302 until end of study at week 16.
  Intervention: Drug: SHR0302
• Placebo Comparator: palcebo
  Participants randomized in this arm will receive placebo until week 8, and then will be re-randomized into one of the 3 active arms (dose A, dose B, and dose C of SHR0302) in a 1:1:1 allocation ratio until the end of study at week 16.
  Interventions:

  • Drug: SHR0302
  • Drug: Placebos

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 16, 2018): 152
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2020
• Estimated Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male and Female subject age ≥ 18 and ≤75 years of age at randomization.
• Active ulcerative colitis with a 9-point modified Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (The duration of the time between endoscopy and baseline should not exceed 10 days and allow central over read turn over before randomization).
• Subject should have at least three-month history of Ulcerative Colitis diagnosis at randomization.

Exclusion Criteria:

• Diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
• Subjects with ulcerative colitis, which is confined to a proctitis (distal 15 cm or less).
• Treatment naïve subjects diagnosed with ulcerative colitis (without previous exposure to treatment).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Max Zhang; +8618662156927; max.zhang@reistonebio.com

• Listed Location Countries: China, Poland, Ukraine, United States

Administrative Information

• NCT Number: NCT03675477
• Other Study ID Numbers: RSJ10101; 2018-003364-31 ( EudraCT Number )
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Reistone Biopharma Company Limited
• Study Sponsor: Reistone Biopharma Company Limited
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Reistone Biopharma Company Limited
• Verification Date: June 2019