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
3 other identifiers
interventional
59
4 countries
24
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2012
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedStudy Start
First participant enrolled
January 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2013
CompletedResults Posted
Study results publicly available
March 11, 2015
CompletedMay 23, 2019
May 1, 2019
1.6 years
October 17, 2011
October 15, 2014
May 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Experiencing a Treatment Emergent Adverse Event
8 weeks
Secondary Outcomes (3)
Number of Participants Achieving Clinical Response
Baseline to 8 weeks
Number of Participants Achieving Clinical Remission
Baseline to 8 weeks
Change From Baseline in Total Modified Mayo Score
Baseline to 8 weeks
Study Arms (3)
Low Dose Telotristat Etiprate
EXPERIMENTAL500 mg telotristat etiprate (LX1606) administered orally once daily (QD).
High Dose Telotristat Etiprate
EXPERIMENTAL500 mg telotristat etiprate (LX1606) administered orally three times daily (TID).
Placebo
PLACEBO COMPARATORMatching placebo administered orally.
Interventions
500 mg telotristat etiprate (LX1606) administered orally.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Lexicon Investigational Site
Little Rock, Arkansas, 72205, United States
Lexicon Investigational Site
Anaheim, California, 92801, United States
Lexicon Investigational Site
Santa Monica, California, 90404, United States
Lexicon Investigational Site
Great Neck, New York, 11021, United States
Lexicon Investigational Site
New York, New York, 10017, United States
Lexicon Investigational Site
Tulsa, Oklahoma, 74135, United States
Lexicon Investigational Site
Houston, Texas, 77030, United States
Lexicon Investigational Site
San Antonio, Texas, 78229, United States
Lexicon Investigational Site
Ogden, Utah, 84405, United States
Lexicon Investigational Site
Sandy City, Utah, 84094, United States
Lexicon Investigational Site
Seattle, Washington, 98195, United States
Lexicon Investigational Site
Kaunas, LT-50009, Lithuania
Lexicon Investigational Site
Klaipėda, LT-92288, Lithuania
Lexicon Investigational Site
Šiauliai, LT-76231, Lithuania
Lexicon Investigational Site
Vilnius, LT-03215, Lithuania
Lexicon Investigational Site
Vilnius, LT-08661, Lithuania
Lexicon Investigational Site
Krakow, 31531, Poland
Lexicon Investigational Site
Lodz, 90302, Poland
Lexicon Investigational Site
Sopot, 81756, Poland
Lexicon Investigational Site
Warsaw, 03580, Poland
Lexicon Investigational Site
Wroclaw, 53025, Poland
Lexicon Investigational Site
Wroclaw, 54144, Poland
Lexicon Investigational Site
Nitra, 94901, Slovakia
Lexicon Investigational Site
Nové Mesto nad Váhom, 91501, Slovakia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Manager of Regulatory Affairs
- Organization
- Lexicon Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Doug Fleming, MD
Lexicon Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2011
First Posted
October 20, 2011
Study Start
January 30, 2012
Primary Completion
September 3, 2013
Study Completion
September 3, 2013
Last Updated
May 23, 2019
Results First Posted
March 11, 2015
Record last verified: 2019-05