Phase 2
Completed N=59
A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis
Source: ClinicalTrials.gov NCT01456052 ↗Enrolled (actual)
59
Serious AEs
10.3%
Results posted
Mar 2015
Primary outcomePrimary: Number of Participants Experiencing a Treatment Emergent Adverse Event — 3; 9; 10 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing a Treatment Emergent Adverse Event |
3; 9; 10 | — |
| SECONDARY Number of Participants Achieving Clinical Response |
4; 8; 8 | — |
| SECONDARY Number of Participants Achieving Clinical Remission |
2; 2; 3 | — |
| SECONDARY Change From Baseline in Total Modified Mayo Score |
-2.38; -1.89; -2.53 | — |
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
Data sourced from ClinicalTrials.gov (NCT01456052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.