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

May 9, 2019 updated by: Lexicon Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kaunas, Lithuania, LT-50009
        • Lexicon Investigational Site
      • Klaipeda, Lithuania, LT-92288
        • Lexicon Investigational Site
      • Siauliai, Lithuania, LT-76231
        • Lexicon Investigational Site
      • Vilnius, Lithuania, LT-03215
        • Lexicon Investigational Site
      • Vilnius, Lithuania, LT-08661
        • Lexicon Investigational Site
      • Krakow, Poland, 31531
        • Lexicon Investigational Site
      • Lodz, Poland, 90302
        • Lexicon Investigational Site
      • Sopot, Poland, 81756
        • Lexicon Investigational Site
      • Warszawa, Poland, 03580
        • Lexicon Investigational Site
      • Wroclaw, Poland, 53025
        • Lexicon Investigational Site
      • Wroclaw, Poland, 54144
        • Lexicon Investigational Site
      • Nitra, Slovakia, 94901
        • Lexicon Investigational Site
      • Nove Mesto nad Vahom, Slovakia, 91501
        • Lexicon Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Lexicon Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Lexicon Investigational Site
      • Santa Monica, California, United States, 90404
        • Lexicon Investigational Site
    • New York
      • Great Neck, New York, United States, 11021
        • Lexicon Investigational Site
      • New York, New York, United States, 10017
        • Lexicon Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • Lexicon Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Lexicon Investigational Site
      • San Antonio, Texas, United States, 78229
        • Lexicon Investigational Site
    • Utah
      • Ogden, Utah, United States, 84405
        • Lexicon Investigational Site
      • Sandy, Utah, United States, 84094
        • Lexicon Investigational Site
    • Washington
      • Seattle, Washington, United States, 98195
        • Lexicon Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Dose Telotristat Etiprate
500 mg telotristat etiprate (LX1606) administered orally once daily (QD).
500 mg telotristat etiprate (LX1606) administered orally.
Experimental: High Dose Telotristat Etiprate
500 mg telotristat etiprate (LX1606) administered orally three times daily (TID).
500 mg telotristat etiprate (LX1606) administered orally.
Placebo Comparator: Placebo
Matching placebo administered orally.
Matching placebo administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Experiencing a Treatment Emergent Adverse Event
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Achieving Clinical Response
Time Frame: Baseline to 8 weeks

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.

Baseline to 8 weeks
Number of Participants Achieving Clinical Remission
Time Frame: Baseline to 8 weeks

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.

Baseline to 8 weeks
Change From Baseline in Total Modified Mayo Score
Time Frame: Baseline to 8 weeks
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.
Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Doug Fleming, MD, Lexicon Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2012

Primary Completion (Actual)

September 3, 2013

Study Completion (Actual)

September 3, 2013

Study Registration Dates

First Submitted

October 17, 2011

First Submitted That Met QC Criteria

October 18, 2011

First Posted (Estimate)

October 20, 2011

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 9, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • LX1606.1-204-UC
  • LX1606.204 (Other Identifier: Lexicon Pharmaceuticals, Inc.)
  • LX1032 (Other Identifier: Lexicon Pharmaceuticals, Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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