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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 June 2023 |
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Main ID: |
NCT03675477 |
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Date of registration:
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16/09/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.
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Scientific title:
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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. |
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Date of first enrolment:
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April 13, 2019 |
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Target sample size:
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164 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03675477 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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China
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Poland
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Puerto Rico
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Ukraine
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United States
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Contacts
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Name:
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Xiang Chen |
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Address:
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Telephone:
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Email:
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Affiliation:
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Reistone Pharma |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: SHR0302
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Drug: Placebo
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Primary Outcome(s)
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The Percentage of Subject Achieve Clinical Response at Week 8
[Time Frame: Week 8]
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Secondary Outcome(s)
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The Percentage of Subjects Achieve Clinical Remission
[Time Frame: Week 8]
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The Percentage of Subjects Achieve Clinical Remission at Week 8
[Time Frame: Week 8]
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The Percentage of Subjects Achieve Endoscopic Remission (Mucosal Healing) at Week 8
[Time Frame: Week 8]
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Secondary ID(s)
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2018-003364-31
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RSJ10101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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