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

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



Sponsors


Source

Lexicon Pharmaceuticals

Oversight Info

Has Dmc

No


Brief Summary

This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and
preliminary effectiveness of two blinded dose levels of LX1606 in subjects with acute, mild
to moderate ulcerative colitis on 5-aminosalicylic acid/mesalamine therapy.

Overall Status

Completed

Start Date

2012-01-30

Completion Date

2013-09-03

Primary Completion Date

2013-09-03

Phase

Phase 2

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Number of Subjects Experiencing a Treatment Emergent Adverse Event
8 weeks

Secondary Outcome

Measure

Time Frame

Number of Subjects Achieving Clinical Response
Baseline to 8 weeks
Number of Subjects Achieving Clinical Remission
Baseline to 8 weeks
Change From Baseline in Total Modified Mayo Score
Baseline to 8 weeks

Enrollment

59

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

500 mg LX1606 administered orally once daily (QD)

Arm Group Label

Low Dose LX1606


Intervention Type

Drug

Intervention Name


Description

500 mg LX1606 administered orally three times daily (TID)

Arm Group Label

High Dose LX1606


Intervention Type

Drug

Intervention Name


Description

Matching placebo administered orally

Arm Group Label

Placebo



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

Gender

All

Minimum Age

18 Years

Maximum Age

70 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Doug Fleming, MD
Study Director
Lexicon Pharmaceuticals, Inc.

Location

Facility

Lexicon Investigational Site
Little Rock Arkansas 72205 United States
Lexicon Investigational Site
Anaheim California 92801 United States
Lexicon Investigational Site
Santa Monica California 90404 United States
Lexicon Investigational Site
Great Neck New York 11021 United States
Lexicon Investigational Site
New York New York 10017 United States
Lexicon Investigational Site
Tulsa Oklahoma 74135 United States
Lexicon Investigational Site
Houston Texas 77030 United States
Lexicon Investigational Site
San Antonio Texas 78229 United States
Lexicon Investigational Site
Ogden Utah 84405 United States
Lexicon Investigational Site
Sandy City Utah 84094 United States
Lexicon Investigational Site
Seattle Washington 98195 United States
Lexicon Investigational Site
Kaunas LT-50009 Lithuania
Lexicon Investigational Site
Klaipeda LT-92288 Lithuania
Lexicon Investigational Site
Siauliai LT-76231 Lithuania
Lexicon Investigational Site
Vilnius LT-03215 Lithuania
Lexicon Investigational Site
Vilnius LT-08661 Lithuania
Lexicon Investigational Site
Krakow 31531 Poland
Lexicon Investigational Site
Lodz 90302 Poland
Lexicon Investigational Site
Sopot 81756 Poland
Lexicon Investigational Site
Warszawa 03580 Poland
Lexicon Investigational Site
Wroclaw 53025 Poland
Lexicon Investigational Site
Wroclaw 54144 Poland
Lexicon Investigational Site
Nitra 94901 Slovakia
Lexicon Investigational Site
Nove Mesto nad Vahom 91501 Slovakia

Location Countries

Country

Lithuania

Poland

Slovakia

United States



Verification Date

2017-07-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Secondary Id

LX1606.204

LX1032


Number Of Arms

3

Arm Group

Arm Group Label

Low Dose LX1606

Arm Group Type

Experimental


Arm Group Label

High Dose LX1606

Arm Group Type

Experimental


Arm Group Label

Placebo

Arm Group Type

Placebo Comparator



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)


Study First Submitted

October 17, 2011

Study First Submitted Qc

October 18, 2011

Study First Posted

October 20, 2011

Last Update Submitted

July 12, 2017

Last Update Submitted Qc

July 12, 2017

Last Update Posted

August 10, 2017

Results First Submitted

October 15, 2014

Results First Submitted Qc

March 10, 2015

Results First Posted

March 11, 2015


ClinicalTrials.gov processed this data on August 23, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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