Acute mild to moderate ulcerative colitis MedDRA version: 14.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Product Name: LX1606
Product Code: LX1606
Pharmaceutical Form: Capsule
INN or Proposed INN: Telotristat etiprate
CAS Number: 1137608-69-5
Current Sponsor code: LX1606, LX1032
Other descriptive name: t
Sponsors
Lexicon Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be considered eligible to participate in the study: 1. Diagnosis of ulcerative colitis of at least 6 months duration 2. Disease extends at least 15cm proximally from the anal verge (defined as the transitional zone between the perianal skin and the surface of the anal canal) documented within the past 3 years. Flare occurs on a background of 5-ASA/mesalamine therapy; subject is willing to remain on stable dose for the duration of the blinded trial period. 4. Age >18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the trial 1. Subject has had any prior terminal ileum or colonic surgery, except appendectomy or hemorrhoid surgery. 2. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn’s disease. 3. Subjects displaying clinical signs of fulminant colitis or toxic megacolon. 4. Subjects with a history of Dysplasia associated lesion or mass (DALM). 5. Subjects who have had surgery for UC or in the opinion of the Investigator, are likely to require surgery for UC during the study period. 6. Subjects with a history of primary sclerosing cholangitis. 7. Any physical finding or laboratory abnormality the investigator deems clinically significant that would pose a safety issue for the subject or interfere with interpretation of the data. 8. Major surgery within 60 days prior to Screening. 9. Administration of any investigational agent within 30 days of Screening or any therapeutic protein or antibody within 90 days of Screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the safety and tolerability of orally administered LX1606 after 8 weeks in a cohort of subjects with acute, mild to moderate ulcerative colitis.;Secondary Objective: • Examine the relationship between reductions in 5-HIAA levels and clinical improvement in ulcerative colitis • Evaluate differences between each LX1606 dose group and placebo for the following measures at Week 8: - Proportion of subjects achieving clinical response - Proportion of subjects achieving clinical remission - Change from baseline in the total modified Mayo score ;Primary end point(s): Assessment of safety and tolerability of LX1606 after 8 weeks in a cohort of subjects with acute, mild to moderate ulcerative colitis. ;Timepoint(s) of evaluation of this end point: Throughout the duration of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Examination of the relationship between reductions in 5-HIAA levels and clinical improvement in ulcerative colitis - Evaluatation of differences between each LX1606 dose group and placebo for the following measures at Week 8: Proportion of subjects achieving clinical response Proportion of subjects achieving clinical remission Change from baseline in the total modified 1 Mayo score 1 Endoscopy evaluation is based on modified criteria: 0 = Normal or inactive disease 1 = Mild disease (erythema, decreased vascular pattern, no friability 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions) 3 = Severe disease (spontaneous bleeding, ulceration);Timepoint(s) of evaluation of this end point: Week 8 | — |
Countries
Belgium, Lithuania, Poland, Slovakia, United States
Contacts
Public ContactLinda Law
Lexicon Pharmaceuticals, Inc.
Outcome results
None listed