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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Telotristat Etiprate
Placebo
Sponsored by
Lexicon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site
  • Lexicon Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low Dose Telotristat Etiprate

High Dose Telotristat Etiprate

Placebo

Arm Description

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

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

Matching placebo administered orally.

Outcomes

Primary Outcome Measures

Number of Participants Experiencing a Treatment Emergent Adverse Event

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 17, 2011
Last Updated
May 9, 2019
Sponsor
Lexicon Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01456052
Brief Title
A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 30, 2012 (Actual)
Primary Completion Date
September 3, 2013 (Actual)
Study Completion Date
September 3, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lexicon Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose Telotristat Etiprate
Arm Type
Experimental
Arm Description
500 mg telotristat etiprate (LX1606) administered orally once daily (QD).
Arm Title
High Dose Telotristat Etiprate
Arm Type
Experimental
Arm Description
500 mg telotristat etiprate (LX1606) administered orally three times daily (TID).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo administered orally.
Intervention Type
Drug
Intervention Name(s)
Telotristat Etiprate
Intervention Description
500 mg telotristat etiprate (LX1606) administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo administered orally.
Primary Outcome Measure Information:
Title
Number of Participants Experiencing a Treatment Emergent Adverse Event
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Achieving Clinical Response
Description
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
Title
Number of Participants Achieving Clinical Remission
Description
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
Title
Change From Baseline in Total Modified Mayo Score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doug Fleming, MD
Organizational Affiliation
Lexicon Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Lexicon Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Lexicon Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Lexicon Investigational Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Lexicon Investigational Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Lexicon Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Lexicon Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Lexicon Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Lexicon Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Lexicon Investigational Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Lexicon Investigational Site
City
Sandy
State/Province
Utah
ZIP/Postal Code
84094
Country
United States
Facility Name
Lexicon Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Lexicon Investigational Site
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Lexicon Investigational Site
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
Lexicon Investigational Site
City
Siauliai
ZIP/Postal Code
LT-76231
Country
Lithuania
Facility Name
Lexicon Investigational Site
City
Vilnius
ZIP/Postal Code
LT-03215
Country
Lithuania
Facility Name
Lexicon Investigational Site
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Lexicon Investigational Site
City
Krakow
ZIP/Postal Code
31531
Country
Poland
Facility Name
Lexicon Investigational Site
City
Lodz
ZIP/Postal Code
90302
Country
Poland
Facility Name
Lexicon Investigational Site
City
Sopot
ZIP/Postal Code
81756
Country
Poland
Facility Name
Lexicon Investigational Site
City
Warszawa
ZIP/Postal Code
03580
Country
Poland
Facility Name
Lexicon Investigational Site
City
Wroclaw
ZIP/Postal Code
53025
Country
Poland
Facility Name
Lexicon Investigational Site
City
Wroclaw
ZIP/Postal Code
54144
Country
Poland
Facility Name
Lexicon Investigational Site
City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
Facility Name
Lexicon Investigational Site
City
Nove Mesto nad Vahom
ZIP/Postal Code
91501
Country
Slovakia

12. IPD Sharing Statement

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

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