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An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis

NCT02762500 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2019-04-02

Study results available
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Summary

The purpose of the study is to evaluate the efficacy and safety of LYC-30937-EC given orally once daily in subjects with active ulcerative colitis (UC) defined as a total Mayo score (TMS) of 4-11 inclusive, with an endoscopic score of ≥ 2 and a rectal bleeding score of ≥ 1 at screening.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

LYC-30937-EC

DRUG

Placebo

Sponsors & Collaborators

  • Lycera Corp.

    lead INDUSTRY

Principal Investigators

  • H. Jeffrey Wilkins, MD · Lycera Corp.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • United States
  • Canada
  • Czechia
  • Hungary
  • Netherlands
  • Poland
  • Serbia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02762500 on ClinicalTrials.gov