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This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to preliminarily evaluate the efficacy and safety of SK08 in adult patients with active mild to moderate UC. Each subject will undergo three study periods: screening, induction treatment period and a safety follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SK08 low dose group | Experimental | 1 × 10^7 CFU ~ 2.5 × 10^8 CFU/dose, twice daily (BID), taken orally for 8 weeks |
|
| SK08 high dose group | Experimental | 1 × 10^9 CFU ~ 2.5 × 10^10 CFU/dose, BID, taken orally for 8 weeks |
|
| Placebo group | Placebo Comparator | BID, taken orally for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live SK08 powder | Drug | SK08 is an investigational live biotherapeutic product containing a nontoxigenic B. fragilis(NTBF) strain as an active ingredient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving clinical remission at Week 8 | Clinical remission is defined as a total mMS score of 0 to 2, including the following three components:
| 0-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of subjects with clinical response at Week 8 | Clinical response is defined as a decrease from baseline in the total mMS of ≥ 2 points and at least a 30 percent reduction from baseline, and a decrease in rectal bleeding subs-core of greater than or equal to 1 or an absolute rectal bleeding sub-score of 0 or 1. | 0-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in the IBDQ at Week 8. | 0-8 weeks | |
| Changes from baseline in fecal calprotectin over time | 0-8 weeks | |
| Changes from baseline in serum high-sensitivity C-reactive protein (hsCRP) over time |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yangyang Liu, MD | Contact | China: 020-82515346 | liuyangyang@zypharm.com.cn |
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randomized, double-blind, placebo-controlled
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| Placebo | Drug | Placebo |
|
| proportion of subjects with endoscopic improvement at Week 8 |
Endoscopic improvement is defined as a centrally read endoscopy sub-score of 0 or 1. |
| 0-8 weeks |
| proportion of subjects with endoscopic remission at Week 8 | Endoscopic remission is defined as a centrally read endoscopy sub-score of 0. | 0-8 weeks |
| change from baseline in the total modified Mayo Score at Week 8 | 0-8 weeks |
| mean change in rectal bleeding and stool frequency sub-scores from baseline to Weeks 2, 4, 6 and 8 | 0-2, 0-4, 0-6, 0-8 weeks |
| 0-8 weeks |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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