LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003702-27-DE

Enrollment

762

Registered

2013-12-30

Start date

2014-05-08

Completion date

Unknown

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ulcerative Colitis (UC) MedDRA version: 19.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Interventions

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 S

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Principle Inclusion criteria: - Men or women, 18 to 70 years of age, - Established diagnosis of UC, based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings, - Active UC with disease extent = 15 cm (proctitis only patients to be excluded), confirmed by endoscopy and histology, - Mesalamine (5-ASA) refractory disease, - Elevated stool calprotectin at screening. Inclusion criteria for open-label sub-study: The following inclusion criterion will apply only to the open label sub-study: 1. Patients not in remission of UC at week 12, or patients withdrawn = 8 weeks after randomization due to lack of efficacy and showing no clinical improvement. 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 720 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 42

Exclusion criteria

Exclusion criteria: Principle Exclusion criteria: - Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis, - Colon resection, - Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening), - Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding, - History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack, - Treatment with steroids (oral, inhalative, or intravenous [IV]), cyclosporine or tacrolimus within last 4 weeks prior to randomization, - Treatment with methotrexate within last 6 weeks prior to randomization, - Treatment with TNF-alpha-antagonists, azathioprine, 6-mercaptopurine, or anti-integrin therapy within last 8 weeks prior to randomization, - Treatment with rectal corticosteroid formulation within last 2 weeks prior to randomization, - Concomitant treatment with coumarins (e.g., phenprocoumon), - Existing or intended pregnancy or breast-feeding.

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary: • To prove the superiority of a 12-week add-on treatment with 3.2 g/day gastro-resistant phosphatidylcholine granules (LT-02) in at least one of two different dosing regimens versus LT-02 placebo for the induction of remission in patients with ulcerative colitis (UC) refractory to standard treatment with mesalamine.;Secondary Objective: Secondary: • To study safety and tolerability in the form of adverse events (AEs) and laboratory parameters, • To compare two different dosing regimens of LT-02, • To assess patients’ quality of life.;Primary end point(s): Percentage of patients in remission;Timepoint(s) of evaluation of this end point: after week 12 (LOCF) of double-blind treatment phase	—

Measure

Time frame

Main Objective: Primary: • To prove the superiority of a 12-week add-on treatment with 3.2 g/day gastro-resistant phosphatidylcholine granules (LT-02) in at least one of two different dosing regimens versus LT-02 placebo for the induction of remission in patients with ulcerative colitis (UC) refractory to standard treatment with mesalamine.;Secondary Objective: Secondary: • To study safety and tolerability in the form of adverse events (AEs) and laboratory parameters, • To compare two different dosing regimens of LT-02, • To assess patients’ quality of life.;Primary end point(s): Percentage of patients in remission;Timepoint(s) of evaluation of this end point: after week 12 (LOCF) of double-blind treatment phase

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Secondary

Measure	Time frame
Secondary end point(s): Double-blind (12-week) and optional open-label (12-week) phase: • Percentage of patients with clinical improvement, • Times to first resolution of clinical symptoms, • Number of stools per week, • Number of bloody stools per week, • Number of days with urgency per week, • Percentage of patients with mucosal healing, • Percentage of patients with histologic remission, • Patients quality of life, Open-label phase (only): • Percentage of patients in remission at end of OL phase.;Timepoint(s) of evaluation of this end point: after week 12 (LOCF) of double-blind and/or open-label treatment phase	—

Measure

Time frame

Secondary end point(s): Double-blind (12-week) and optional open-label (12-week) phase: • Percentage of patients with clinical improvement, • Times to first resolution of clinical symptoms, • Number of stools per week, • Number of bloody stools per week, • Number of days with urgency per week, • Percentage of patients with mucosal healing, • Percentage of patients with histologic remission, • Patients quality of life, Open-label phase (only): • Percentage of patients in remission at end of OL phase.;Timepoint(s) of evaluation of this end point: after week 12 (LOCF) of double-blind and/or open-label treatment phase

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Countries

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

Contacts

Public ContactTrial Manager

ICON Clinical Research GmbH

denis.flemm@iconplc.com00492215999223

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026