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

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: Telotristat Etiprate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01456052

LX1032 (Other Identifier)

LX1606.1-204-UC

LX1606.204 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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59 participants in 3 patient groups, including a placebo group

Low Dose Telotristat Etiprate

Experimental group

Description:

500 mg telotristat etiprate (LX1606) administered orally once daily (QD).

Treatment:

Drug: Telotristat Etiprate

High Dose Telotristat Etiprate

Experimental group

Description:

500 mg telotristat etiprate (LX1606) administered orally three times daily (TID).

Treatment:

Drug: Telotristat Etiprate

Placebo

Placebo Comparator group

Description:

Matching placebo administered orally.

Treatment:

Drug: Placebo