Ulcerative Colitis
Conditions
Keywords
Colitis, Colitis, Ulcerative, Ulcer, Colonic Diseases, Digestive System Diseases, Gastroenteritis, Gastrointestinal Diseases, Inflammatory Bowel Diseases, Intestinal Diseases, Pathologic Processes, Mesalamine
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.
Interventions
DRUGLT-02
12-weeks of 1.6 g BID delayed-release phosphatidylcholine (LT-02)
DRUGLT-02 Placebo
12-weeks of 0 g BID delayed-release phosphatidylcholine (LT-02) placebo
Sponsors
Nestlé Health Science Spain
Syneos Health
Prometheus Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion 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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of clinical remission | 12 weeks | The percentage of subjects in clinical remission using the abbreviated modified Mayo score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic response | 12 weeks | Percentage of subjects with endoscopic response |
| Histological improvement | 12 weeks | Percentage of subjects with histological improvement |
| Clinical response | 12 weeks | Percentage of subjects with clinical response using the abbreviated modified Mayo score |
| Mucosal healing | 12 weeks | Percentage of subjects with mucosal healing |
| Quality of life | 12 weeks | Change in the subjects quality of life, using Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ) |
| Endoscopic remission | 12 weeks | Percentage of subjects with endoscopic remission |
Countries
United States
Outcome results
None listed