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| ID | Type | Description | Link |
|---|---|---|---|
| LX1606.204 | Other Identifier | Lexicon Pharmaceuticals, Inc. | |
| LX1032 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Telotristat Etiprate | Experimental | 500 mg telotristat etiprate (LX1606) administered orally once daily (QD). |
|
| High Dose Telotristat Etiprate | Experimental | 500 mg telotristat etiprate (LX1606) administered orally three times daily (TID). |
|
| Placebo | Placebo Comparator | Matching placebo administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telotristat Etiprate | Drug | 500 mg telotristat etiprate (LX1606) administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing a Treatment Emergent Adverse Event | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doug Fleming, MD | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | Little Rock | Arkansas | 72205 | United States | ||
| Lexicon Investigational Site |
The study consisted of an approximately 15 days Screening period prior to the blinded Treatment period.
Up to 60 participants were to be enrolled and treated in the blinded Treatment period across 24 US and international sites. The recruitment period lasted approximately 10 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Matching placebo administered orally. |
| FG001 | Low Dose Telotristat Etiprate | 500 mg telotristat etiprate (LX1606) administered orally once daily (QD). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Matching placebo administered orally. |
|
| 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. | 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. | Baseline to 8 weeks |
| 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 |
| FG002 | High Dose Telotristat Etiprate | 500 mg telotristat etiprate (LX1606) administered orally three times daily (TID). |
| COMPLETED |
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| NOT COMPLETED |
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The baseline analysis population is the safety population. One subject was excluded from the safety population as they did not receive any doses of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo administered orally. |
| BG001 | Low Dose Telotristat Etiprate | 500 mg telotristat etiprate (LX1606) administered orally once daily (QD). |
| BG002 | High Dose Telotristat Etiprate | 500 mg telotristat etiprate (LX1606) administered orally three times daily (TID) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing a Treatment Emergent Adverse Event | Safety population included all treated participants who had taken any fraction of a study drug dose. | Posted | Number | participants | 8 weeks |
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| Secondary | 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. | Intent-to-treat (ITT) Population included all randomly assigned participants. | Posted | Number | participants | Baseline to 8 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population included all randomly assigned participants. | Posted | Number | participants | Baseline to 8 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants from the ITT Population, all randomly assigned participants, with data available for analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 8 weeks |
|
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo administered orally. | 1 | 10 | 3 | 10 | ||
| EG001 | Low Dose Telotristat Etiprate | 500 mg telotristat etiprate (LX1606) administered orally once daily (QD). | 3 | 24 | 9 | 24 | ||
| EG002 | High Dose Telotristat Etiprate | 500 mg telotristat etiprate (LX1606) administered orally three times daily (TID). | 2 | 24 | 2 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Appendicitis | Infections and infestations | MedDRA 14.1 |
| ||
| Iron deficiency anemia | Blood and lymphatic system disorders | MedDRA 14.1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 |
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| Nasopharyngitis | Infections and infestations | MedDRA 14.1 |
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| Sinusitis | Infections and infestations | MedDRA 14.1 |
| ||
| Influenza | Infections and infestations | MedDRA 14.1 |
| ||
| Dizziness | Nervous system disorders | MedDRA 14.1 |
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| Memory impairment | Nervous system disorders | MedDRA 14.1 |
|
Institution must provide any proposed publication or presentation to Sponsor for Sponsor's review, comment and approval at least sixty (60) days prior to the proposed submission for publication date or the proposed presentation date. Sponsor shall have the right to have deleted from the final version of the publication any information to which Sponsor objects, any Confidential Information, proprietary information or patentable subject matter.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Regulatory Affairs | Lexicon Pharmaceuticals, Inc. | 281-863-3260 | plogan@lexpharma.com |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000592493 | telotristat |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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500 mg telotristat etiprate (LX1606) administered orally three times daily (TID).
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| Units | Counts |
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| Participants |
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| Participants |
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