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

Reistone Biopharma Company Limited164 enrolled

Overview

The proposed study is a randomized, double-blind,placebo-controlled, multicenter phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active ulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 and time needed to induce clinical response in active ulcerative colitis patients. This is an 8+8 weeks study, in which participants who complete the first 8 weeks treatment phase, will have the option to enter a blinded active arms 8-week extension phase. Early withdrawn subjects during the first treatment phase can not enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 18 weeks. SHR0302 is a Janus kinase 1(JAK1) inhibitor, capable of blocking Janus kinase-signal transducer and activator of transcription (JAK-STATs) pathway and controlling inflammation. Therefore it has the potential to be a treatment for ulcerative colitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

164

Conditions

Ulcerative Colitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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).

Locations (67)

Wellness Clinical Research, LLLC-Central Florida

Lake Wales, Florida, United States

West Central Gastroenterology d/b/a Gastro Florida

Tampa, Florida, United States

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, United States

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

The Percentage of Subject Achieve Clinical Response at Week 8

Clinical response is defined as a decrease from baseline in a 9-point modified Mayo score of at least 2 points and at least 30%, with an accompanying reduction in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1. The 9-point modified Mayo score is the Mayo score excluding the Physician Global Assessment sub-score, hence the maximum is 9 points and the minimum is 0 point, includes: Stool Frequency 0 = Normal 1. = 1-2 stools/day more than normal 2. = 3-4 stools/day more than normal 3. = 5 or more stools/day than normal Rectal bleeding 0 = None 1. = Visible blood with stool less than half the time 2. = Visible blood with stool half of the time or more 3. = Passing blood alone Mucosal appearance at endoscopy 0 = Normal or inactive disease 1. = Mild disease (erythema, decreased vascular pattern, mild friability 2. = Moderate disease (marked erythema, absent vascular pattern, friability, erosio

Time frame: Week 8

Secondary Outcomes

The Percentage of Subjects Achieve Clinical Remission

Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual sub-score exceeding 1 point. The percentage of subjects who 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. 9-point modified Mayo score includes: Stool Frequency 0 = Normal 1. = 1-2 stools/day more than normal 2. = 3-4 stools/day more than normal 3. = 5 or more stools/day than normal Rectal bleeding 0 = None 1. = Visible blood with stool less than half the time 2. = Visible blood with stool half of the time or more 3. = Passing blood alone Mucosal appearance at endoscopy 0 = Normal or inactive disease 1. = Mild disease (erythema, decreased vascular pattern, mild friability 2. = Moderate disease (marked erythema, absent vascular pattern, friability, erosions) 3. = Severe disease (spontaneous bleeding, ulceration)

Time frame: Week 8

The Percentage of Subjects Achieve Clinical Remission at Week 8

Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual sub-score exceeding 1 point. The percentage of subjects achieve clinical remission at week 8 as per a total Mayo score of 2 points or lower ≤2, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. The 9-point modified Mayo score includes: Stool Frequency 0 = Normal 1. = 1-2 stools/day more than normal 2. = 3-4 stools/day more than normal 3. = 5 or more stools/day than normal Rectal bleeding 0 = None 1. = Visible blood with stool less than half the time 2. = Visible blood with stool half of the time or more 3. = Passing blood alone Mucosal appearance at endoscopy 0 = Normal or inactive disease 1. = Mild disease (erythema, decreased vascular pattern, mild friability 2. = Moderate disease (marked erythema, absent vascular patt

Time frame: Week 8

The Percentage of Subjects Achieve Endoscopic Remission (Mucosal Healing) at Week 8

Endoscopic remission was defined by Mayo endoscopic subscore ≤ 1 point. Mayo endoscopic subscore defines score 0 as normal or inactive disease, score 1 as mild disease (erythema, decreased vascular pattern, mild friability); score 2 as moderate disease (marked erythema, absent vascular pattern, friability, erosions)； score 3 as severe disease (spontaneous bleeding, ulceration).

Time frame: Week 8