Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2) (PROTECT-2)

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

The purpose of this study is 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)

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: LT-02; Drug: Placebo; Drug: Mesalamine

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Frankfurt a.M., Germany, 60431
    • AGAPLESION Markus-Krankenhaus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Major Inclusion Criteria:

• Signed informed consent
• Men or women, 18 to 70 years of age
• Historically confirmed diagnosis of UC by endoscopy and histology
• Patients being in clinical and endoscopical remission at baseline
• Negative pregnancy test in females of childbearing potential at baseline visit

Major Exclusion Criteria:

• Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis
• Toxic megacolon or fulminant colitis
• Colon resection
• Malabsorption syndromes
• Celiac disease
• Bleeding hemorrhoids
• 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
• 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
• Any relevant known systemic disease (e.g., AIDS, active tuberculosis)
• Severe co-morbidity substantially reducing life expectancy
• History of cancer in the last five years
• Abnormal hepatic function at screening visit, liver cirrhosis
• Abnormal renal function at screening visit
• Patients with known hypersensitivity to soy
• Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP: LT-02 or mesalamine)
• 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 mesalamine or corticosteroid formulations within last 2 weeks prior to randomization
• Treatment with other investigational drug within last 12 weeks prior to randomization except LT-02
• Existing or intended pregnancy or breast-feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LT-02; LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily	Drug: LT-02; LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily
Placebo Comparator: Placebo; LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily	Drug: Placebo; LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily
Active Comparator: Mesalamine; LT-02 PLACEBO twice daily AND 500mg mesalamine PLACEBO three-times daily	Drug: Mesalamine; LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients who are relapse-free and are not a treatment failure	48 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in the total mDAI	48 weeks

Collaborators and Investigators

• Sponsor: Dr. Falk Pharma GmbH
• Investigators: Principal Investigator: Axel Dignass, Prof Dr, Agaplesion Markus Krankenhaus

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): October 5, 2018
• Study Completion (Actual): October 5, 2018

Study Registration Dates

• First Submitted: October 29, 2014
• First Submitted That Met QC Criteria: October 30, 2014
• First Posted (Estimate): October 31, 2014

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: PCG-4/UCR; 2013-001205-84 (EudraCT Number)