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This study will evaluate the efficacy and safety of 627 in patients with UC.
Ulcerative colitis (UC) is a chronic non-specific intestinal disease characterized by continuous and diffuse inflammatory changes in the colorectal mucosa. Despite the availability of advanced therapies, there remains a significant unmet medical need, such as inadequate or loss of response to one or more of the following therapies, corticosteroid dependence, or intolerance to one or more therapies. The purpose of this study is to evaluate the efficacy and safety of 627 in patients with moderate to severe UC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group M1 | Experimental | dose level 1 of 627 |
|
| Group M2 | Experimental | dose level 2 of 627 |
|
| Group M3 | Experimental | dose level 3 of 627 |
|
| Group M4 | Experimental | dose level 4 of 627 |
|
| Group A | Experimental | 627 Dose A subcutaneous (SC) injection. |
|
| Group B | Experimental | 627 Dose B subcutaneous (SC) injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 627 | Drug | 627 subcutaneous (SC) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | During the 36-week study period |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission based on Mayo Score (MMS) | Proportion of subjects achieving clinical remission based on Mayo Score (MMS) (Rectal Bleeding Score [RBS] = 0, Endoscopic Score [ES] ≤ 1 without friability, and Stool Frequency Score [SFS] ≤ 1and not exceeding baseline). | Week 14 |
| Clinical response based on Mayo Score (MMS) |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax). | During the 36-week study period | |
| Area under the Concentration-Time Curve up to the Last Measurable Concentration (AUC 0-last). | During the 36-week study period. | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qinghong Zhou | Contact | +86 18911301578 | zhouqinghong@3sbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo |
| Placebo Comparator |
Placebo subcutaneous (SC) injection. |
|
| Group C | Experimental | 627 subcutaneous (SC) injection. |
|
| Placebo | Drug | Placebo subcutaneous (SC) injection. |
|
Proportion of subjects achieving clinical response based on Mayo Score (MMS) (≥2-point and ≥30% reduction in MMS from baseline, and ≥1-point reduction in Rectal Bleeding Score [RBS] or RBS value ≤1 point). |
| Week 14 |
| Endoscopic improvement | Proportion of subjects achieving endoscopic improvement (Endoscopic Score [ES] ≤ 1 without friability). | Week 14 |
| Endoscopic remission | Proportion of subjects achieving endoscopic remission (Endoscopic Score [ES] = 0). | Week 14 |
| Symptomatic remission | Proportion of subjects achieving symptomatic remission (Rectal Bleeding Score [RBS] = 0 and Stool Frequency Score [SFS] = 0). | During the 36-week study period |
| Symptomatic response | Proportion of subjects achieving symptomatic response (≥30% reduction from baseline in combined RBS and SFS total scores). | During the 36-week study period |
| Time to achievement of symptomatic remission and symptomatic response | During the 36-week study period |
| Time to Peak Concentration (Tmax). |
| During the 36-week study period. |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |