A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02849951
• Date of registration: 26/07/2016
• Prospective Registration: No
• Primary sponsor: Prometheus Laboratories
• Public title: A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC) PROTECT-3
• Scientific title: A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of a 12-week Add-on Treatment With LT-02 vs. Placebo in Subjects With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine
• Date of first enrolment: July 2016
• Target sample size: 25
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02849951
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Gregory Gordon, M.D., J.D.
• Affiliation: Nestle Health Science, Medical Director

Key inclusion & exclusion criteria

Key Inclusion Criteria:

1. Established diagnosis of ulcerative colitis (UC), based on clinical history, exclusion
of infectious causes, and characteristic endoscopic and histologic findings.

2. Active UC with disease confirmed by endoscopy findings and confirmed by central
reader.

3. A modified Mayo Score 4-10, and with a centrally read endoscopy score activity of = 2
points.

4. Mesalamine (5-ASA) refractory.

Exclusion Criteria:

1. Diagnosis of 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. Prior colon resection,

4. Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile
infection) at screening,

5. Known celiac disease

6. Other inflammatory or bleeding disorders of the colon and intestine, or diseases what
may cause diarrhea or gastrointestinal bleeding

7. History or presence of ischemic heart disease, myocardial infarction, peripheral
arterial disease, ischemic stroke, or transient ischemic attack,

8. Subjects with known hypersensitivity to soy,

9. Treatment with methotrexate, azathioprine, 6-mercaptopurine TNF-alpha-antagonists,
vedolizumab or certolizumab pegol, tacrolimus, or anti-integrin therapy within last 8
weeks prior to screening,

10. Treatment with any (topical or systemic) corticosteroid formulation for the treatment
of IBD within last 7 days prior to endoscopy,

11. Treatment with other investigational drug within last 8 weeks prior to screening,



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: LT-02 Placebo

Drug: LT-02

Primary Outcome(s)

Rate of clinical remission [Time Frame: 12 weeks]

Secondary Outcome(s)

Clinical response [Time Frame: 12 weeks]

Endoscopic remission [Time Frame: 12 weeks]

Mucosal healing [Time Frame: 12 weeks]

Histological improvement [Time Frame: 12 weeks]

Endoscopic response [Time Frame: 12 weeks]

Quality of life [Time Frame: 12 weeks]

Secondary ID(s)

16GI01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

INC Research

Nestlé Health Science Spain