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

NCT ID: NCT02493712

Last Updated: 2021-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-04-30

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.

Detailed Description

Study IBD98-M-2002 is a Phase 2a, multicenter, randomized, double-blind, parallel-group, placebo-controlled study in patients with active, mild to moderate UC. It is being conducted as an exploratory proof of concept study to investigate the clinical efficacy of IBD98-M delayed-release capsules (in a fixed combination) over a 6-week treatment period and a 2-week follow-up period.

Patients will be screened for study enrollment up to 4 weeks prior to randomization (Visit 3). During the screening period, patients will be evaluated by conducting laboratory tests, physical examination, and sigmoidoscopy. To be eligible, patients are to have a score of ≥4 and ≤10 on the UCDAI, and a score of ≥1 on the UCDAI endoscopy subscore. In addition, the diagnosis of UC must be confirmed by endoscopic and histologic evidence in the past; if prior confirmation is not available, this must be done at the time of screening endoscopy. After the screening visits, eligible patients will be randomized to 1 of 3 study groups: (1) IBD98 M 0.8 g/day (mesalamine 0.8 g with sodium hyaluronate 92 mg), (2) IBD98 M 1.2 g/day (mesalamine 1.2 g with sodium hyaluronate 138 mg), or (3) placebo. Up to 51 patients will be enrolled in this study (including drop-out patients), with 17 patients randomized to each treatment group. Patients will be encouraged to take their medication at the same time every day.

During the study, patients will visit the clinic on 7 occasions: 2 visits during the screening period (the second screening visit is the baseline visit); 4 visits during the treatment period, Visits 3, 4, 5, and 6/early termination at Weeks 0, 2, 4, and 6; and 1 visit at the end of the follow-up period, Visit 7 at Week 8. Patients will record the dates/times of dosing (after randomization), concomitant medication, and symptoms and adverse events (AEs) in a daily diary starting at Visit 1 and continuing until the end of treatment (Visit 6/early termination). Rescue medication will not be permitted during the 6 weeks of the treatment period, and patients who are considered to not be benefiting from the therapy can be withdrawn and assigned an appropriate alternative UC treatment by the Investigator. Compliance will be assessed throughout the study by determining the amount of unused medication. Records will be kept of all medication dispensed, used, and returned by each patient. At the end of the study, all unused trial medication and used packaging will be returned to the Sponsor. All study medication will be accounted for and any discrepancies documented.

Conditions

Colitis, Ulcerative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High dose

High dose, twice a day for 6 weeks.

Group Type: EXPERIMENTAL

High dose

Intervention Type: DRUG

6 capsules of IBD98-M, twice a day

Placebo: C

Placebo, twice a day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Low dose

Low dose, twice a day for 6 weeks

Group Type: EXPERIMENTAL

Low dose

Intervention Type: DRUG

4 capsules of IBD98-M

Interventions

High dose

6 capsules of IBD98-M, twice a day

Intervention Type: DRUG

Low dose

4 capsules of IBD98-M

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Mesalamine-Sodium Hyaluronic 200 mg-23 mg; Mesalamine-Sodium Hyaluronic 200 mg-23 mg

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

inVentiv Health Clinical

OTHER

Sponsor Role: collaborator

Holy Stone Healthcare Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvio Danese

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

Istituto Clinico Humanitas

Milan, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IBD98-M-2002

Identifier Type: -

Identifier Source: org_study_id