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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456052
• Other study ID #: LX1606.1-204-UC
• Secondary ID: LX1606.204LX1032
• Status: Completed
• Phase: Phase 2
• Start date: January 30, 2012
• Est. completion date: September 3, 2013

Study information

• Verified date: May 2019
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 3, 2013
• Est. primary completion date: September 3, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Telotristat Etiprate
500 mg telotristat etiprate (LX1606) administered orally.
• Placebo
Matching placebo administered orally.

Locations

Country	Name	City	State
Lithuania	Lexicon Investigational Site	Kaunas
Lithuania	Lexicon Investigational Site	Klaipeda
Lithuania	Lexicon Investigational Site	Siauliai
Lithuania	Lexicon Investigational Site	Vilnius
Lithuania	Lexicon Investigational Site	Vilnius
Poland	Lexicon Investigational Site	Krakow
Poland	Lexicon Investigational Site	Lodz
Poland	Lexicon Investigational Site	Sopot
Poland	Lexicon Investigational Site	Warszawa
Poland	Lexicon Investigational Site	Wroclaw
Poland	Lexicon Investigational Site	Wroclaw
Slovakia	Lexicon Investigational Site	Nitra
Slovakia	Lexicon Investigational Site	Nove Mesto nad Vahom
United States	Lexicon Investigational Site	Anaheim	California
United States	Lexicon Investigational Site	Great Neck	New York
United States	Lexicon Investigational Site	Houston	Texas
United States	Lexicon Investigational Site	Little Rock	Arkansas
United States	Lexicon Investigational Site	New York	New York
United States	Lexicon Investigational Site	Ogden	Utah
United States	Lexicon Investigational Site	San Antonio	Texas
United States	Lexicon Investigational Site	Sandy	Utah
United States	Lexicon Investigational Site	Santa Monica	California
United States	Lexicon Investigational Site	Seattle	Washington
United States	Lexicon Investigational Site	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Countries where clinical trial is conducted

United States,  Lithuania,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing a Treatment Emergent Adverse Event		8 weeks
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.	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.	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.	Baseline to 8 weeks