- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01456052
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Kaunas, Lithuania, LT-50009
- Lexicon Investigational Site
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Klaipeda, Lithuania, LT-92288
- Lexicon Investigational Site
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Siauliai, Lithuania, LT-76231
- Lexicon Investigational Site
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Vilnius, Lithuania, LT-03215
- Lexicon Investigational Site
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Vilnius, Lithuania, LT-08661
- Lexicon Investigational Site
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Krakow, Poland, 31531
- Lexicon Investigational Site
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Lodz, Poland, 90302
- Lexicon Investigational Site
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Sopot, Poland, 81756
- Lexicon Investigational Site
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Warszawa, Poland, 03580
- Lexicon Investigational Site
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Wroclaw, Poland, 53025
- Lexicon Investigational Site
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Wroclaw, Poland, 54144
- Lexicon Investigational Site
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Nitra, Slovakia, 94901
- Lexicon Investigational Site
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Nove Mesto nad Vahom, Slovakia, 91501
- Lexicon Investigational Site
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Lexicon Investigational Site
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California
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Anaheim, California, United States, 92801
- Lexicon Investigational Site
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Santa Monica, California, United States, 90404
- Lexicon Investigational Site
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New York
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Great Neck, New York, United States, 11021
- Lexicon Investigational Site
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New York, New York, United States, 10017
- Lexicon Investigational Site
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Oklahoma
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Tulsa, Oklahoma, United States, 74135
- Lexicon Investigational Site
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Texas
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Houston, Texas, United States, 77030
- Lexicon Investigational Site
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San Antonio, Texas, United States, 78229
- Lexicon Investigational Site
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Utah
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Ogden, Utah, United States, 84405
- Lexicon Investigational Site
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Sandy, Utah, United States, 84094
- Lexicon Investigational Site
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Washington
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Seattle, Washington, United States, 98195
- Lexicon Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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Experimental: Low Dose Telotristat Etiprate
500 mg telotristat etiprate (LX1606) administered orally once daily (QD).
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500 mg telotristat etiprate (LX1606) administered orally.
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Experimental: High Dose Telotristat Etiprate
500 mg telotristat etiprate (LX1606) administered orally three times daily (TID).
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500 mg telotristat etiprate (LX1606) administered orally.
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Placebo Comparator: Placebo
Matching placebo administered orally.
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Matching placebo administered orally.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Number of Participants Experiencing a Treatment Emergent Adverse Event
Time Frame: 8 weeks
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants Achieving Clinical Response
Time Frame: Baseline to 8 weeks
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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
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Number of Participants Achieving Clinical Remission
Time Frame: Baseline to 8 weeks
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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
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Change From Baseline in Total Modified Mayo Score
Time Frame: Baseline to 8 weeks
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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.
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Baseline to 8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Doug Fleming, MD, Lexicon Pharmaceuticals, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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Clinical Trials on Telotristat Etiprate
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Lexicon PharmaceuticalsCompleted
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Lexicon PharmaceuticalsCompletedCarcinoid SyndromeUnited States, Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom
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Lexicon PharmaceuticalsCompletedCarcinoid SyndromeUnited States, Australia, Belgium, Canada, France, Germany, Israel, Spain, Sweden, United Kingdom, Netherlands
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IpsenCompletedHepatic ImpairmentMoldova, Republic of, Romania
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Lexicon PharmaceuticalsCompletedHepatic ImpairmentUnited States
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Lexicon PharmaceuticalsCompletedCarcinoid SyndromeUnited States, Australia, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom, Canada, Israel
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IpsenCompletedRenal ImpairmentMoldova, Republic of, Belgium, Germany, Romania
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Lexicon PharmaceuticalsCompletedCarcinoid SyndromeGermany, United Kingdom
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Lexicon PharmaceuticalsCompletedDrug InteractionsUnited States
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Lexicon PharmaceuticalsCompleted