A Pilot Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis

• Register: EUCTR
• Last refreshed on: 27 January 2014
• Main ID: EUCTR2011-003532-32-SK
• Date of registration: 10/11/2011
• Prospective Registration: Yes
• Primary sponsor: Lexicon Pharmaceuticals, Inc.
• Public title: A Pilot Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis
• Scientific 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
• Date of first enrolment: 19/12/2011
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003532-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Belgium, Lithuania, Poland, Slovakia, United States

Contacts

• Name: Linda Law
• Affiliation: Lexicon Pharmaceuticals, Inc.

• Name: Linda Law
• Affiliation: Lexicon Pharmaceuticals, Inc.

Key inclusion & exclusion 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 <70 years at the time of Screening.
5. Ability and willingness to provide written informed consent prior to participation in any study-related activities and to participate in and comply with the study requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Acute mild to moderate ulcerative colitis
MedDRA version: 14.0 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

Product Name: LX1606
Product Code: LX1606
Pharmaceutical Form: Capsule
INN or Proposed INN: Non as of yet
CAS Number: 1137608-69-5
Current Sponsor code: LX1606, LX1032
Other descriptive name: telotristat etiprate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

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

Timepoint(s) of evaluation of this end point: Throughout the duration of the study

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.

Secondary Outcome(s)

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

Secondary ID(s)

LX1606.1-204-UC

Source(s) of Monetary Support

Lexicon Pharmaceuticals, Inc.