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Trial record 1 of 1 for:    NCT03675477
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A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.

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

Tracking Information
First Submitted Date  ICMJE September 16, 2018
First Posted Date  ICMJE September 18, 2018
Last Update Posted Date August 19, 2019
Actual Study Start Date  ICMJE April 13, 2019
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT03675477 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 16, 2018)
152
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Max Zhang +8618662156927 max.zhang@reistonebio.com
Listed Location Countries  ICMJE China,   Poland,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03675477
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Reistone Biopharma Company Limited
Study Sponsor  ICMJE Reistone Biopharma Company Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Reistone Biopharma Company Limited
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP