Clinical trial NCT02849951: A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of a 12-week Add-on Treatment With LT-02 vs. Placebo in Subjects With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Mesalamine
Lead sponsor: Prometheus Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Nestlé Health Science Spain
name: Syneos Health
First posted: 2016-07-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Phosphatidylcholine (LT-02) add on treatment is effective and safe for the induction of remission in ulcerative colitis patients refractory to standard treatment with mesalamine

Detailed description: A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of LT-02 (delayed release phosphatidylcholine granules; administered orally via 1.6 g BID for up to 12 weeks) in subjects with active ulcerative colitis who are refractory to a standard dose of oral mesalamine therapy. Refractory to mesalamine is defined as active disease despite receiving at least ≥ 2.4g mesalamine (or equivalent dose) for at least 8 weeks with or without rectal 5-ASA.

Eligibility criteria: Key Inclusion Criteria:

1. Established diagnosis of ulcerative colitis (UC), based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings.
2. Active UC with disease confirmed by endoscopy findings and confirmed by central reader.
3. A modified Mayo Score 4-10, and with a centrally read endoscopy score activity of ≥ 2 points.
4. Mesalamine (5-ASA) refractory.

Exclusion Criteria:

1. Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis,
2. Toxic megacolon or fulminant colitis,
3. Prior colon resection,
4. Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile infection) at screening,
5. Known celiac disease
6. Other inflammatory or bleeding disorders of the colon and intestine, or diseases what may cause diarrhea or gastrointestinal bleeding
7. History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack,
8. Subjects with known hypersensitivity to soy,
9. Treatment with methotrexate, azathioprine, 6-mercaptopurine TNF-alpha-antagonists, vedolizumab or certolizumab pegol, tacrolimus, or anti-integrin therapy within last 8 weeks prior to screening,
10. Treatment with any (topical or systemic) corticosteroid formulation for the treatment of IBD within last 7 days prior to endoscopy,
11. Treatment with other investigational drug within last 8 weeks prior to screening,

Primary outcomes:
measure: Rate of clinical remission
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinical response
timeFrame: 12 weeks
measure: Endoscopic response
timeFrame: 12 weeks
measure: Histological improvement
timeFrame: 12 weeks
measure: Endoscopic remission
timeFrame: 12 weeks
measure: Mucosal healing
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Prometheus Site 24
state: Arizona
city: Little Rock
country: United States
facility: Prometheus Site 10
state: Arkansas
city: Chula Vista
country: United States
facility: Prometheus Site 15
state: California
city: Lancaster
country: United States
facility: Prometheus Site 42
state: California
city: Oceanside
country: United States
facility: Prometheus Site 30
state: California
city: Rialto
country: United States
facility: Prometheus Site 28
state: California
city: Ventura
country: United States
facility: Prometheus Site 2
state: California
city: Lafayette
country: United States
facility: Prometheus Site 27
state: Colorado
city: Lone Tree
country: United States
facility: Prometheus Site 45
state: Colorado
city: Clearwater
country: United States
facility: Prometheus Site 35
state: Florida
city: Fort Lauderdale
country: United States
facility: Prometheus Site 17
state: Florida
city: Hialeah
country: United States
facility: Prometheus Site 55
state: Florida
city: Naples
country: United States
facility: Prometheus Site 8
state: Florida
city: Naples
country: United States
facility: Prometheus Site 13
state: Florida
city: Orlando
country: United States
facility: Prometheus Site 36
state: Florida
city: Orlando
country: United States
facility: Prometheus Site 44
state: Florida
city: Athens
country: United States
facility: Prometheus Site 37
state: Georgia
city: Decatur
country: United States
facility: Prometheus Site 11
state: Georgia
city: Chicago
country: United States
facility: Prometheus Site 53
state: Illinois
city: Hoffman Estates
country: United States
facility: Prometheus Site 54
state: Illinois
city: Topeka
country: United States
facility: Prometheus Site 20
state: Kansas
city: Shreveport
country: United States
facility: Prometheus Site 4
state: Louisiana
city: Chevy Chase
country: United States
facility: Prometheus Site 5
state: Maryland
city: Brockton
country: United States
facility: Prometheus Research Site 1
state: Massachusetts
city: Chesterfield
country: United States
facility: Prometheus Site 6
state: Michigan
city: Southfield
country: United States
facility: Prometheus Site 51
state: Michigan
city: Wyoming
country: United States
facility: Prometheus Site 48
state: Michigan
city: Plymouth
country: United States
facility: Prometheus Site 31
state: Minnesota
city: Saint Louis
country: United States
facility: Prometheus Site 40
state: Missouri
city: Lebanon
country: United States
facility: Prometheus Site 21
state: New Hampshire
city: Great Neck
country: United States
facility: Prometheus Site 22
state: New York
city: Poughkeepsie
country: United States
facility: Prometheus Site 33
state: New York
city: The Bronx
country: United States
facility: Prometheus Site 26
state: New York
city: Greenville
country: United States
facility: Prometheus Site 41
state: North Carolina
city: Kinston
country: United States
facility: Prometheus Site 32
state: North Carolina
city: Columbia
country: United States
facility: Prometheus Site 43
state: South Carolina
city: Rapid City
country: United States
facility: Prometheus Site 7
state: South Dakota
city: Houston
country: United States
facility: Prometheus Site 49
state: Texas
city: Humble
country: United States
facility: Prometheus Site 39
state: Texas
city: San Antonio
country: United States
facility: Prometheus Site 47
state: Texas
city: San Antonio
country: United States
facility: Prometheus Site 9
state: Texas
city: Orem
country: United States
facility: Prometheus Site 23
state: Utah
city: Salt Lake City
country: United States
facility: Prometheus Site 25
state: Utah
city: Charlottesville
country: United States
facility: Prometheus Site 34
state: Virginia
city: Richland
country: United States
facility: Prometheus Site 12
state: Washington
Study officials:
affiliation: Nestle Health Science, Medical Director
name: Gregory Gordon, M.D., J.D.
role: STUDY_DIRECTOR
References: