An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: LYC-30937-EC; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the efficacy and safety of LYC-30937-EC given orally
      once daily in subjects with active ulcerative colitis (UC) defined as a total Mayo score
      (TMS) of 4-11 inclusive, with an endoscopic score of ≥ 2 and a rectal bleeding score of ≥ 1
      at screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical UC diagnosis ≥ 6 months prior to screening with minimum disease extent of ≥
             15cm from anal verge.

          -  Active UC defined as a TMS of 4-11 (inclusive) with endoscopic subscore of ≥ 2 and
             rectal bleeding subscore of ≥ 1 at screening.

          -  Females of childbearing potential must have a negative pregnancy test at screening and
             baseline visits and must agree to use acceptable methods of birth control while in the
             trial and for 30 days after taking the last dose of study drug.

          -  May be currently receiving treatment with oral aminosalicylates (ASA) for ≥ 6 weeks at
             a stable dose for ≥ 3 weeks prior to the screening screening endoscopy and/or
             thiopurine at a stable dose ≥ 8 weeks prior to the screening endoscopy and/or
             prednisone (dose 20 mg daily) or equivalent for ≥ 4 weeks and receiving stable dose
             for ≥ 2 weeks prior to screening endoscopy

          -  able to provide written informed consent and be compliant with study procedures.

        Exclusion Criteria:

          -  History of Crohn's disease (CD) or indeterminate colitis or the presence or history of
             fistula consistent with CD.

          -  Presence of colon polyps.

          -  Severe extensive disease that in the investigators discretion is likely to require
             colonic surgery during the 8 week double-blind portion of the trial (eg, fulminant
             colitis, toxic megacolon, bowel perforation, evidence of acute abdomen).

          -  History of alcohol or drug abuse within 1 year of randomization.

          -  History of cancer including solid tumors and hematological malignancies (except basal
             cell and in situ squamous cell carcinomas of the skin that have been adequately
             treated with no recurrence for ≥ 1 year prior to screening.

          -  History or currently active primary or secondary immunodeficiency.

          -  Clinically relevant hepatic, neurologic, pulmonary, ophthalmological,
             gastrointestinal, endocrine, psychiatric, or other major systemic disease making
             implementation of the study difficult or that would put the subject at risk by
             participating in the study

          -  Positive test for Clostridium difficile or positive stool culture for enteric
             pathogens or presence of ova or parasites at screening.

          -  Liver function tests > 1.5 x upper limit of normal (ULN) or direct bilirubin > 1.5 x
             ULN

          -  Hemoglobin < 8.5 g/dl

          -  Neutrophils < 1500/mm3

          -  White blood cell (WBC) count < 3000/mm3

          -  Platelets < 80000 mm3

          -  International normalized ratio (INR) > 1.5

          -  Treatment with an immunosuppressant agent within 8 weeks of screening.

          -  Previous exposure to ≥ 2 approved or investigational biologic agents to treat UC.

          -  History of UC treatment with a biologic agent within 12 weeks of screening.

          -  Treatment with rectal steroids within 2 weeks of screening.

          -  Treatment with an investigational agent within 30 days of screening.