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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675477
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Reistone Biopharma Company Limited

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 Early withdrawn subjects during the first treatment phasecannot enter the extension phase.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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: SHR0302 Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 13, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: SHR0302 dose A
Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 16.
Drug: SHR0302
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).

Active Comparator: SHR0302 dose B
Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 16.
Drug: SHR0302
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).

Active Comparator: SHR0302 dose C
Participants randomized in this arm will receive dose D of SHR0302 until end of study at week 16.
Drug: SHR0302
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).

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.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675477


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

Locations
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Sponsors and Collaborators
Reistone Biopharma Company Limited
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Responsible Party: Reistone Biopharma Company Limited
ClinicalTrials.gov Identifier: NCT03675477    
Other Study ID Numbers: RSJ10101
2018-003364-31 ( EudraCT Number )
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases