LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

• Register: EUCTR
• Last refreshed on: 12 November 2018
• Main ID: EUCTR2013-001205-84-BE
• Date of registration: 17/02/2015
• Prospective Registration: Yes
• Primary sponsor: Dr. Falk Pharma GmbH
• Public title: LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis
• Scientific title: Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC
• Date of first enrolment: 11/03/2016
• Target sample size: 400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001205-84
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Czech Republic, Germany, Hungary, Israel, Latvia, Lithuania, Netherlands, Poland, Russian Federation, Slovakia, Switzerland, Ukraine

Contacts

• Name: Denis Flemm
• Affiliation: Aptiv Solutions, an ICON plc company

• Name: Denis Flemm
• Affiliation: Aptiv Solutions, an ICON plc company

Key inclusion & exclusion 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 360
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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.





Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 17.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Intervention(s)

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
Pharmaceutical Form: Gastro-resistant granules
INN or Proposed INN: Phosphatidylcholine
CAS Number: 97281-47-5
Current Sponsor code: LT-02
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 800-
Pharmaceutical form of the placebo: Gastro-resistant granules
Route of administration of the placebo: Oral use

Trade Name: Salofalk Granu-Stix 500 mg
Pharmaceutical Form: Gastro-resistant granules
INN or Proposed INN: MESALAZINE
CAS Number: 89-57-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Gastro-resistant granules
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: Primary:
To prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC)

Secondary Objective: Secondary:
To study safety and tolerability in the form of adverse events (AEs) and laboratory parameters,
To assess patients’ quality of life.

Primary end point(s): Percentage of patients who are relapse-free and are not a treatment failure after 48 weeks of treatment.

Timepoint(s) of evaluation of this end point: After week 48 (LOCF) of double-blind treatment phase

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: After week 48 (LOCF) of double-blind treatment phase

Secondary end point(s): • Mean change from baseline in the total mDAI at V6/EOT.
• Time to relapse or discontinuation,
• Time to relapse.

Secondary ID(s)

PROTECT-2

2013-001205-84-DE

PCG-4/UCR

Source(s) of Monetary Support

Dr. Falk Pharma GmbH