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A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03677648
Recruitment Status : Active, not recruiting
First Posted : September 19, 2018
Last Update Posted : July 27, 2021
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 investigate the safety and efficacy of SHR0302 in patients with moderate to severe active Crohn's Disease. The study aims to evaluate the optimal dose of SHR0302 and time needed in inducing clinical remission in active CD. This is an 12+12 weeks study, in which participants who complete the first 12 weeks treatment phase, will have the option to enter a blinded active arms 12-week extension phase. Early withdrawn subjects during the first treatment phase cannot enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 26 weeks.

With the wealth of scientific evidence on JAK/STAT involvement in IBD, the data from similar class of new drugs and the current data on SHR0302 (JAK1 inhibitor), support the rationale to proceed with phase II studies to evaluate the efficacy and safety of SHR0302 in patients with moderate to severe active CD.


Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: SHR0302 Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Placebo Controlled, Double-blind, Four Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Crohn's Disease
Actual Study Start Date : May 14, 2019
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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 24.
Drug: SHR0302
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).

Experimental: SHR0302 dose B
Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 24.
Drug: SHR0302
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).

Experimental: SHR0302 dose C
Participants randomized in this arm will receive dose C of SHR0302 until end of study at week 24.
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: Placebo
Participants randomized in this arm will receive placebo until week 12, 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 24.
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
Placebos




Primary Outcome Measures :
  1. The percentage of subjects achieving clinical remission at week 12. [ Time Frame: week12 ]
    The percentage of subjects achieving clinical remission at week 12, defined as Crohn's Disease Activity Index (CDAI) score < 150.


Secondary Outcome Measures :
  1. The percentage of subjects achieving clinical remission defined as mean daily stool frequency (SF) ≤2.5, and abdominal pain (AP) ≤ 1 using the Patient Reported Outcome from CDAI at week 1, 4, 8, 12, 13, 16, and 24. [ Time Frame: week 1, 4, 8, 12, 13, 16, and 24 ]
    The percentage of subjects achieving clinical remission defined as mean daily stool frequency (SF) ≤2.5, and abdominal pain (AP) ≤ 1 using the Patient Reported Outcome from CDAI at week 1, 4, 8, 12, 13, 16, and 24.

  2. The percentage of subjects achieving clinical remission defined as PRO2 < 8 at week 1, 4, 8, 12, 13, 16, and 24. [ Time Frame: week 1, 4, 8, 12, 13, 16, and 24 ]
    The percentage of subjects achieving clinical remission defined as PRO2 < 8 at week 1, 4, 8, 12, 13, 16, and 24.

  3. The percentage of subjects achieving clinical response defined as a CDAI decrease from baseline of ≥ 100 points at week 1, 4, 8, 12, 13, 16, and 24. [ Time Frame: week 1, 4, 8, 12, 13, 16, and 24 ]
    The percentage of subjects achieving clinical response defined as a CDAI decrease from baseline of ≥ 100 points at week 1, 4, 8, 12, 13, 16, and 24.



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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 at ≥18 and ≤ 75 years of age at randomization.
  • Subjects with a documented three-month history of diagnosed ileal, colonic, or ileocolonic Crohn's Disease at the time of randomization.
  • Currently having Crohn's Disease with Crohn's Disease Activity Index (CDAI) score ≥ 220 to ≤450.

Exclusion Criteria:

  • Diagnosis of indeterminate colitis, or clinical findings suggestive of Ulcerative Colitis.
  • Subject with CD with stoma, gastric or ileoanal pouch, proto-colectomy or total colectomy, symptomatic stenosis or stricture, history of bowel perforation, suspected abscess; actively draining fistula.
  • Treatment naïve subjects diagnosed with Crohn's disease, (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): NCT03677648


Locations
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Sponsors and Collaborators
Reistone Biopharma Company Limited
Investigators
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Study Director: Tia Boonyapredee Reistone Biopharma
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Responsible Party: Reistone Biopharma Company Limited
ClinicalTrials.gov Identifier: NCT03677648    
Other Study ID Numbers: RSJ10201
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: November 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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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases