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

Phase 2 Assessment of the Relationship Between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis

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.

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