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

Phase 3

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: LT-02; Drug: Placebo; Drug: Mesalamine

• Registration Number: NCT02280629
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-01
• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-10-30
• Study First Posted: 2014-10-31
• Primary Completion: 2018-10-05
• Study Completion: 2018-10-05
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LT-02	LT-02	LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily
Placebo	Placebo	LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily
Mesalamine	Mesalamine	LT-02 PLACEBO twice daily AND 500mg mesalamine PLACEBO three-times daily

Primary Outcome Measures

Name	Time	Method
Percentage of patients who are relapse-free and are not a treatment failure	48 weeks

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in the total mDAI	48 weeks

Trial Locations

Locations (1)

Agaplesion Markus-Krankenhaus; 🇩🇪 Frankfurt a.M., Germany