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.
Subjects who voluntarily sign the informed consent form and are able to comply with the study protocol and have the ability to follow relevant procedures.
Male and female subjects aged 18-75 years (inclusive) at the time of signing the informed consent.
Ulcerative colitis diagnosed by routine clinical, endoscopy, and pathologic criteria for at least 3 months.
Subjects with active mild to moderate UC as defined by modified Mayo Score (mMS) of 4-10 (both inclusive), including an endoscopy sub-score of at least 2 and a rectal bleeding sub-score of at least 1.
Subjects with Crohn's disease, radiation colitis, diverticulitis, ischemic colitis, microscopic colitis, drug-related (e.g., NSAIDs, tretinoin, immune checkpoint inhibitors, mycophenolate, etc.) colitis, patients with indeterminate colitis, and patients with endoscopy/biopsy showing ileitis/granulomas with clinical suspicion of Crohn's disease.
Malignancy or history of malignancy within the previous 5 years except for resected cutaneous basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence.
Subjects who received surgery within 30 days before the first dose of study drug or who plan to undergo surgery during the study.
Subjects with other pathological conditions in the intestine, including colon dysplasia, intestinal stricture, tumor, intestinal fistula, intestinal obstruction, celiac disease, etc.
Parallel
Live SK08 powder
DrugSK08 is an investigational live biotherapeutic product containing a nontoxigenic B. fragilis(NTBF) strain as an active ingredient.
Placebo
DrugPlacebo
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: * Stool frequency sub-score = 0 or 1. * Rectal bleeding sub-score = 0 * Centrally read endoscopy sub-score = 0 or 1 (score of 1 modified to exclude friability)
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.
proportion of subjects with endoscopic improvement at Week 8
Endoscopic improvement is defined as a centrally read endoscopy sub-score of 0 or 1.
proportion of subjects with endoscopic remission at Week 8
Endoscopic remission is defined as a centrally read endoscopy sub-score of 0.
change from baseline in the total modified Mayo Score at Week 8
change from baseline in the IBDQ at Week 8.
Changes from baseline in fecal calprotectin over time
Changes from baseline in serum high-sensitivity C-reactive protein (hsCRP) over time
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
