A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): High dose; Low dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 6 capsules of IBD98-M, twice a day; 4 capsules of IBD98-M; Placebo
Other intervention name(s): Mesalamine-Sodium Hyaluronic 200 mg-23 mg; Mesalamine-Sodium Hyaluronic 200 mg-23 mg
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment