Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of SHR-1139 in patients with moderate to severe active ulcerative colitis.
This study consists 2 treatment parts, the Induction treatment part and Maintenance treatment part. The periods of Induction treatment part and Maintenance treatment part are 12 weeks and 48 weeks separately.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | SHR-1139 Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1139 intravenous injection. | Drug | SHR-1139 intravenous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who achieve clinical response (based on modified Mayo score) at week 12. | at week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who achieve clinical remission (based on modified Mayo score) at week 12 and week 60. | at week 12 and week 60. | |
| The proportion of subjects who achieve endoscopic improvement, endoscopic remission and systemic remission at week 12 and week 60. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's Disease.
Subject with Ulcerative Colitis, which is confined to a proctitis (distal 15 cm or less).
Treatment naïve subject diagnosed with Ulcerative Colitis (without previous exposure to any of the following therapies for UC treatment: oral 5-ASA, corticosteroids, immunosuppressants, or biological treatments).
Subject is displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon.
Subject had previous surgery as a treatment for Ulcerative Colitis or likely to require surgery during the study period.
Screening endoscopic examination revealed that the subjects had a history of gastrointestinal dysplasia (atypical hyperplasia)/cancer or dysplasia (atypical hyperplasia)/cancer. Except for completely resected low-grade dysplasia.
Subject has evidence of pathogenic bowel infection. Subjects had Clostridium difficile or other intestinal infection within 30 days of screening endoscopy or test positive at screening for C. difficile toxin or other intestinal pathogens.
Subject currently has or had:
8.1 A clinically significant infection within 1 month of baseline (e.g., those requiring hospitalization or parenteral antimicrobial therapy or have opportunistic infections).
8.2 A history of more than one episode of herpes zoster, or disseminated zoster (single episode).
8.3 Any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study.
8.4 Any infection requiring antimicrobial therapy within 2 weeks of screening.
Subject is receiving any of the following therapies:
9.1 Cyclosporine, mycophenolate, tacrolimus、JAK inhibitors within 4 weeks prior to baseline.
9.2 Interferon therapy within 8 weeks prior to baseline. 9.3 Intravenous corticosteroids or rectally administered formulation of corticosteroids or 5-ASA within 2 weeks prior to baseline.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital,Sun Yat-Sen University | Guangzhou | Guangdong | 510080 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| at week 12 and week 60. |
| The proportion of subjects who achieve clinical response (based on modified Mayo score) at week 60. | at week 12 and week 60. |
| The proportion of subjects whose partial Mayo score ≤1 at each visit. | at week 4, 8, 12, 22, 36, 42 and week 60. |
| The proportion of subjects whose total Mayo score ≤2 and no individual sub-score >1 at week 12 and week 60. | at week 12 and week 60. |