Colitis Ulcerosa remission
Conditions
Interventions
LT-02 (gastro-resistant granules containing 0.8 g phosphatidylcholine [PC] per
sachet) as add-on therapy to a standard dose of * 2.4 g/d mesalamine (or
therapeutic equivalent)
Sponsors
Dr Falk Pharma GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for DB maintenance phase: 1. Signed informed consent, 2. Men or women, 18 to 70 years of age, 3. Historically confirmed diagnosis of UC by endoscopy and histology, 4. Patients being in remission at baseline, 5. Negative pregnancy test in females of childbearing potential at baseline visit, 6. Women of child-bearing potential have to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly.
Exclusion criteria
Exclusion criteria: Exclusion criteria for DB maintenance phase: 1. 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. Colon resection, 4. Malabsorption syndromes, 5. Celiac disease, 6. Bleeding hemorrhoids, 7. Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding, 8. History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack, 9. Any severe concomitant renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient*s compliance or the interpretation of the results, 10. Any relevant known systemic disease (e.g., AIDS, active tuberculosis), 11. Severe co-morbidity substantially reducing life expectancy, 12. History of cancer in the last five years, 13. Abnormal hepatic function at the screening visit), liver cirrhosis, 14. Abnormal renal function at the screening visit, 15. Either HbA1c *6.5% (*48 mmol/mol) at baseline visit, OR HbA1c >5.6% (38 mmol/mol) AND fasting blood glucose *100 mg/dl (*5.6 mmol/l) at baseline visit, 16. Patients with known hypersensitivity to soy, 17. Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP: LT-02 or mesalamine), 18. Treatment with steroids (oral, inhalative, or intravenous [IV]), cyclosporine or tacrolimus within last 4 weeks prior to randomization, 19. Treatment with methotrexate within last 6 weeks prior to randomization, 20. Treatment with TNF-alpha-antagonists, azathioprine, 6-mercaptopurine, or anti-integrin therapy within last 8 weeks prior to randomization, 21. Treatment with rectal mesalamine or corticosteroid formulations within last 2 weeks prior to randomization, 22. Treatment with other investigational drug within last 12 weeks prior to randomization except LT-02, 23. Concomitant treatment with coumarins (e.g., phenprocoumon), 24. Unwillingness to undergo endoscopy with biopsy sampling at end of treatment (EOT)/withdrawal visit of this study, 25. Clinical suspicion of addiction to alcohol or drugs, 26. Existing or intended pregnancy or breast-feeding, 27. Subjects deemed by the investigator to be unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study, 28. Participation in another clinical trial within the last 30 days prior to baseline visit (except for the Phase III study PCG-2/UCA), simultaneous participation in another clinical trial, or previous participation in this trial and having received IMP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Percentage of patients who are relapse-free and are not a treatment failure after 48 weeks of treatment. Relapse is defined as a rectal bleeding score of *1 and a mucosal appearance score of *2 as described in the mDAI score. Treatment failure is defined as premature withdrawal, experiencing UC flare, or need for other UC treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy variables for the DB phase: * Mean change from baseline in the total mDAI at V6/EOT. * Percentage of patients maintaining remission defined as a mDAI score *2 with no subscore >1 at V6/EOT visit, * Number and percentage of patients in each level of change from baseline in the mDAI stool frequency subscore at V2-V5, and V6/EOT, * Number and percentage of patients in each level of change from baseline in the mDAI rectal bleeding subscore at V2-V5, and V6/EOT, * Number and percentage of patients in each level of change from baseline in the mDAI Physician*s rating of disease subscore at V2-V5, and V6/EOT, * Time to clinical relapse or discontinuation, * Number and percentage of patients in each level of change from baseline in the mDAI mucosal appearance subscore at V6/EOT, Total mDAI and change in mDAI clinical subscores in the course of the DB phase, * Percentage of patients with endoscopic remission defined as mDAI mucosal appearance score of *1, * Total and change in Clinical Activity Index acc. to Rachmilewitz (CAI) and its subscores in the course of the DB phase, * Number and percentage of patients in each level of change from baseline in the CAI in the course of the DB phase, * Percentage of patients in clinical remission (CAI *4, with stool frequency and rectal bleeding subscores of *0*) in the course of the DB phase, * Endoscopic Index (EI) and its change in the course of the DB phase, * Percentage of patients in endoscopic remission (EI *3), * Percentage of patients with endoscopic improvement (decrease *1 point in EI), and endoscopic deterioration (increase *1 point in EI), * Number and percentage of patients in each level of change from baseline in the EI in the course of the DB phase, * Histological Index (HI) and its change in the course of the DB phase, * Percentage of patients in the categories histologic remission (HI * 1), mild (HI=2), moderate (HI=3), and severe (HI=4) activity at EOT/withdrawal visit, | — |
Countries
Netherlands
Outcome results
None listed