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

Completed · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT01456052

Run by

Lexicon Pharmaceuticals

People needed

59

Starts

2012-01-30

Expected to finish

2013-09-03

Last updated by the study team

2019-05-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lexicon Investigational Site — Little Rock, Arkansas, United States
• Lexicon Investigational Site — Anaheim, California, United States
• Lexicon Investigational Site — Santa Monica, California, United States
• Lexicon Investigational Site — Great Neck, New York, United States
• Lexicon Investigational Site — New York, New York, United States
• Lexicon Investigational Site — Tulsa, Oklahoma, United States
• Lexicon Investigational Site — Houston, Texas, United States
• Lexicon Investigational Site — San Antonio, Texas, United States
• Lexicon Investigational Site — Ogden, Utah, United States
• Lexicon Investigational Site — Sandy City, Utah, United States
• Lexicon Investigational Site — Seattle, Washington, United States
• Lexicon Investigational Site — Kaunas, Lithuania
• Lexicon Investigational Site — Klaipėda, Lithuania
• Lexicon Investigational Site — Šiauliai, Lithuania
• Lexicon Investigational Site — Vilnius, Lithuania
• Lexicon Investigational Site — Vilnius, Lithuania
• Lexicon Investigational Site — Krakow, Poland
• Lexicon Investigational Site — Lodz, Poland
• Lexicon Investigational Site — Sopot, Poland
• Lexicon Investigational Site — Warsaw, Poland
• Lexicon Investigational Site — Wroclaw, Poland
• Lexicon Investigational Site — Wroclaw, Poland
• Lexicon Investigational Site — Nitra, Slovakia
• Lexicon Investigational Site — Nové Mesto nad Váhom, Slovakia

Full record on ClinicalTrials.gov

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