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

Lexicon Pharmaceuticals59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Ulcerative Colitis

Interventions

Telotristat EtiprateDRUG

500 mg telotristat etiprate (LX1606) administered orally.

PlaceboDRUG

Matching placebo administered orally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (24)

Lexicon Investigational Site

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Number of Participants Experiencing a Treatment Emergent Adverse Event

Time frame: 8 weeks

Secondary Outcomes

Number of Participants Achieving Clinical Response

Clinical response is defined as a decrease in the total modified Mayo score from baseline of ≥3 or a ≥30% decrease in the total modified Mayo score from baseline, along with a decrease in the rectal bleeding score ≥1 or an absolute rectal bleeding score ≤1 at Week 8. A modified Mayo score was used to evaluate disease activity using 4 components, including stool frequency, rectal bleeding, endoscopy, and physician assessment. Components = Stool frequency score 0-3 (normal- \>4 stools/day more than normal), rectal bleeding score 0-3 (none-passing blood alone), mucosal appearance at endoscopy 0-3 (normal-severe disease), physician rating of disease activity 0-3 (normal-severe). The total Modified Mayo score ranges from 0 to 12, with higher scores indicating greater disease severity.

Time frame: Baseline to 8 weeks

Number of Participants Achieving Clinical Remission

Clinical remission is defined as a total modified Mayo score ≤2 with no individual score \>1 at Week 8. A modified Mayo score was used to evaluate disease activity using 4 components, including stool frequency, rectal bleeding, endoscopy, and physician assessment. Components = Stool frequency score 0-3 (normal- \>4 stools/day more than normal), rectal bleeding score 0-3 (none-passing blood alone), mucosal appearance at endoscopy 0-3 (normal-severe disease), physician rating of disease activity 0-3 (normal-severe). The total Modified Mayo score ranges from 0 to 12, with higher scores indicating greater disease severity.

Time frame: Baseline to 8 weeks

Change From Baseline in Total Modified Mayo Score

A modified Mayo score was used to evaluate disease activity using 4 components, including stool frequency, rectal bleeding, endoscopy, and physician assessment. Components = Stool frequency score 0-3 (normal- \>4 stools/day more than normal), rectal bleeding score 0-3 (none-passing blood alone), mucosal appearance at endoscopy 0-3 (normal-severe disease), physician rating of disease activity 0-3 (normal-severe). The total Modified Mayo score ranges from 0 to 12, with higher scores indicating greater disease severity.

Data from ClinicalTrials.gov

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