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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


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Study Type
Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02493712

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Holy Stone Healthcare Co., Ltd

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Silvio Danese
Principal Investigator Affiliation Istituto Clinico Humanitas

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
IndustryOther
Overall Status Recruiting
Countries Italy

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Colitis, Ulcerative
Additional Details

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.

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International Sites

Istituto Clinico Humanitas, Milan, Italy

Status

Recruiting

Address

Istituto Clinico Humanitas

Milan, ,

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