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

NCT02493712 | Completed Phase 2 Results

• 1 other identifier: IBD98-M-2002
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• Remission Rate

  Percentage of patients in remission over a 6-week treatment period. Remission is defined as a modified UCDAI (Ulcerative Colitis Disease Activity Index) score of ≤1, with a score of 0 for rectal bleeding and stool frequency, no mucosal friability, and sigmoidoscopy score not exceeding 1). Modified UCDAI scoring system is sum of following 4 subscores (parameters). Higher score means worst disease condition. Rectal bleeding: score 1 (Streaks of blood), score 2 (obvious blood), score 3 (Mostly Blood) Stool frequency: score 1 (1-2/day\> normal), score 2 (3-4/day \>normal), score 3 (\>4/day\> normal) Mucosal appearance: score 1 (Erythema, decreased vascular pattern, Minimal granularity), score 2 (Marked erythema, Friability, Granularity, Absent vascular pattern, Bleeding minimal trauma, No ulcerations), score 3 (Ulceration Spontaneous bleeding) Physician's Global Assessment: score 1 (mild), score 2 (Moderate), score 3 (Severe)

  6 weeks

Secondary Outcomes (1)

• Improvement Rate

  6 weeks

Study Arms (3)

High dose

EXPERIMENTAL

High dose, twice a day for 6 weeks.

Drug: High dose

Placebo: C

PLACEBO COMPARATOR

Placebo, twice a day

Drug: Placebo

Low dose

EXPERIMENTAL

Low dose, twice a day for 6 weeks

Drug: Low dose

Interventions

High dose DRUG

6 capsules of IBD98-M, twice a day

Also known as: Mesalamine-Sodium Hyaluronic 200 mg-23 mg

High dose

Low dose DRUG

4 capsules of IBD98-M

Also known as: Mesalamine-Sodium Hyaluronic 200 mg-23 mg

Low dose

Placebo DRUG

Placebo

Placebo: C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Holy Stone Healthcare Co., Ltd: lead
• inVentiv Health Clinical: collaborator

Study Sites (1)

Istituto Clinico Humanitas

Milan, Italy

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Contraceptives, Oral

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Results Point of Contact

• Title: YUCHIH, Chen
• Organization: Holy Stone Healthcare Co., Ltd

ivychen@hshc.com.tw

886287975966

Study Officials

• Silvio Danese

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 9, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: April 1, 2019
• Last Updated: October 26, 2021
• Results First Posted: August 14, 2020

Record last verified: 2021-09

Locations

IT (1)