Ulcerative ColitisPhase 2NCT01456052
A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis
A Phase 2 study testing Telotristat Etiprate in people with Ulcerative Colitis, run by Lexicon Pharmaceuticals at 24 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Telotristat Etiprate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 30 Jan 2012to 3 Sep 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
United States11 sites
Lexicon Investigational Site
Anaheim, California, 92801
Lexicon Investigational Site
Great Neck, New York, 11021
Lexicon Investigational Site
Houston, Texas, 77030
Lexicon Investigational Site
Little Rock, Arkansas, 72205
Lexicon Investigational Site
New York, New York, 10017
Lexicon Investigational Site
Ogden, Utah, 84405
Lexicon Investigational Site
San Antonio, Texas, 78229
Lexicon Investigational Site
Sandy City, Utah, 84094
Lexicon Investigational Site
Santa Monica, California, 90404
Lexicon Investigational Site
Seattle, Washington, 98195
Lexicon Investigational Site
Tulsa, Oklahoma, 74135
Poland6 sites
Lexicon Investigational Site
Krakow, 31531
Lexicon Investigational Site
Lodz, 90302
Lexicon Investigational Site
Sopot, 81756
Lexicon Investigational Site
Warsaw, 03580
Lexicon Investigational Site
Wroclaw, 53025
Lexicon Investigational Site
Wroclaw, 54144
Lithuania5 sites
Lexicon Investigational Site
Kaunas, LT-50009
Lexicon Investigational Site
Klaipėda, LT-92288
Lexicon Investigational Site
Šiauliai, LT-76231
Lexicon Investigational Site
Vilnius, LT-03215
Lexicon Investigational Site
Vilnius, LT-08661
Slovakia2 sites
Lexicon Investigational Site
Nitra, 94901
Lexicon Investigational Site
Nové Mesto nad Váhom, 91501
About this study
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
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Telotristat Etiprate, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telotristat EtiprateDrug
500 mg telotristat etiprate (LX1606) administered orally.
PlaceboDrug
Matching placebo administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Telotristat Etiprate | Experimental | 500 mg telotristat etiprate (LX1606) administered orally once daily (QD). Receives: Drug: Telotristat Etiprate |
| High Dose Telotristat Etiprate | Experimental | 500 mg telotristat etiprate (LX1606) administered orally three times daily (TID). Receives: Drug: Telotristat Etiprate |
| Placebo | Placebo comparator | Matching placebo administered orally. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing a Treatment Emergent Adverse Event
Measured: 8 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study start30 Jan 2012
- Primary completion3 Sep 2013
- Study completion3 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doug Fleming, MD, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456052
- Sponsor's protocol ID
- LX1606.1-204-UC
- Other IDs
- LX1606.204, LX1032
- Status last verified
- May 2019
- First submitted
- 17 Oct 2011
- Last updated
- 23 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01456052
- Acronym / sponsor ID
- LX1606.1-204-UC
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2012 (actual)
- Primary completion
- 3 Sep 2013 (actual)
- Study completion
- 3 Sep 2013 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Posted 11 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose Telotristat Etiprate | Experimental | Drug: Telotristat Etiprate500 mg telotristat etiprate (LX1606) administered orally once daily (QD). |
| High Dose Telotristat Etiprate | Experimental | Drug: Telotristat Etiprate500 mg telotristat etiprate (LX1606) administered orally three times daily (TID). |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo administered orally. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telotristat Etiprate500 mg telotristat etiprate (LX1606) administered orally. | Drug | High Dose Telotristat Etiprate, Low Dose Telotristat Etiprate |
| PlaceboMatching placebo administered orally. | Drug | Placebo |
Primary outcome
Number of Participants Experiencing a Treatment Emergent Adverse Event
Time frame: 8 weeks
3 secondary outcomes
Number of Participants Achieving Clinical Response
Time frame: Baseline to 8 weeks
Number of Participants Achieving Clinical Remission
Time frame: Baseline to 8 weeks
Change From Baseline in Total Modified Mayo Score
Time frame: Baseline to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doug Fleming, MD study director
Lexicon Pharmaceuticals, Inc.
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telotristat Etiprate in people with Ulcerative Colitis, run by Lexicon Pharmaceuticals at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Poland, Lithuania, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing a Treatment Emergent Adverse Event (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.