Phase 2
N=51
A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M
Colitis, Ulcerative
Bottom Line
View on ClinicalTrials.gov: NCT02493712 ↗Enrolled (actual)
51
Serious AEs
2.0%
Results posted
Aug 2020
Primary outcome: Primary: Remission Rate — 2; 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- High dose (Drug); Low dose (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Holy Stone Healthcare Co., Ltd
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Remission Rate |
2; 1; 2 | — |
| SECONDARY Improvement Rate |
5; 3; 3 | — |
Summary
IBD98-M-2002 is a phase 2a , Randomized, Double blind, Placebo-controlled of IBD98-M Delayed Release capsules in subjects with Mild to Moderately Ulcerative Colitis to investigate the clinical efficacy of IBD98-M delayed release capsules (in a fixed combination) over a 6-week treatment period and 2 weeks follow up.
Eligibility Criteria
Inclusion Criteria
- Male or female, age ≥18 and <75 years, suffering from UC for at least 6 months prior to screening
- Female patients must be postmenopausal, sterile, or have a negative urine pregnancy test prior to entering the study and use adequate contraception during the study if of childbearing potential.
- Diagnosis of active UC with UCDAI ≥4 and ≤10, with endoscopy score of ≥1 in the UCDAI mucosal appearance subscore
Exclusion Criteria
- Patients diagnosed with Crohn's disease, indeterminate colitis, or ischemic colitis
- Female patients who are pregnant or breastfeeding
- Ulcerative proctitis with ≤15 cm of disease
- Patients with infectious colitis as determined by assessment for Clostridium difficile (C. difficile) and fecal pathogens at screening or treatment for C. difficile within 30 days prior to screening
- History of or current evidence of toxic megacolon, fulminant colitis (e.g., Lichtiger score of ≥10), colonic perforation
Data sourced from ClinicalTrials.gov (NCT02493712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.