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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Drug: High dose
* Drug: Low dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose<br>High dose, twice a day for 6 weeks. | Drug: High dose<br>* 6 capsules of IBD98-M, twice a day<br>* Other names: Mesalamine-Sodium Hyaluronic 200 mg-23 mg;|
| Placebo Comparator: Placebo: C<br>Placebo, twice a day | Drug: Placebo<br>* Placebo<br>|
| Experimental: Low dose<br>Low dose, twice a day for 6 weeks | Drug: Low dose<br>* 4 capsules of IBD98-M<br>* Other names: Mesalamine-Sodium Hyaluronic 200 mg-23 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement Rate | Clinical improvement over a 6-weeks treatment period was defined as a ≥ 3 point reduction from Baseline in the modified UCDAI (Ulcerative Colitis Disease Activity Index ) score. 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, decrased 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 |