A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis

• Status: Completed
• Trial end date: 2013-09-03
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and preliminary effectiveness of two blinded dose levels of telotristat etiprate (LX1606) in participants with acute, mild to moderate ulcerative colitis on 5-aminosalicylic acid/mesalamine therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lexicon Pharmaceuticals

Criteria

Inclusion Criteria:

• Diagnosis of ulcerative colitis of at least 6 months duration

• Disease extends at least 15 cm proximally from the anal verge, documented within the past 3 years

• Flare occurs on 5-aminosalicylic acid (5-ASA)/mesalamine therapy and subject is willing to remain on a stable dose for the duration of the study

• Age ≥18 and <70 years of age

• Able and willing to provide written informed consent

Exclusion Criteria:

• Prior terminal ileum or colonic surgery, except appendectomy or hemorrhoid surgery

• Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease

• Clinical signs of fulminant colitis or toxic megacolon

• History of dysplasia associated lesion or mass (DALM)

• Subjects who have had surgery for ulcerative colitis, or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study

• History of primary sclerosing cholangitis

• Any physical or laboratory abnormality deemed by the investigator as clinically significant

• Major surgery within 60 days of Screening

• Use of any investigational agent within 30 days of Screening or any therapeutic protein or antibody within 90 days of Screening