A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02493712
• Date of registration: 07/07/2015
• Prospective Registration: Yes
• Primary sponsor: Holy Stone Healthcare Co., Ltd
• Public title: A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M
• Scientific title: A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients With Active, Mild to Moderate Ulcerative Colitis
• Date of first enrolment: January 2016
• Target sample size: 51
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02493712
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Italy, Taiwan

Contacts

• Name: Silvio Danese
• Affiliation: Istituto Clinico Humanitas

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female, age =18 and <75 years, suffering from UC for at least 6 months prior
to screening

2. 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.

3. Diagnosis of active UC with UCDAI =4 and =10, with endoscopy score of =1 in the UCDAI
mucosal appearance subscore

Exclusion Criteria:

1. Patients diagnosed with Crohn's disease, indeterminate colitis, or ischemic colitis

2. Female patients who are pregnant or breastfeeding

3. Ulcerative proctitis with =15 cm of disease

4. 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

5. History of or current evidence of toxic megacolon, fulminant colitis (e.g., Lichtiger
score of =10), colonic perforation



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: Low dose

Drug: High dose

Drug: Placebo

Primary Outcome(s)

Remission Rate [Time Frame: 6 weeks]

Secondary Outcome(s)

Improvement Rate [Time Frame: 6 weeks]

Secondary ID(s)

IBD98-M-2002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

inVentiv Health Clinical

Results

• Results available: Yes
• Date Posted: 14/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02493712