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

NCT ID: NCT02762500

Last Updated: 2019-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-05-31

Brief 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.

Detailed Description

Approximately 120 subjects will be randomized to receive either enteric-coated (EC) LYC-30937-EC 25 mg PO once daily (QD) or matching placebo PO QD for the duration of 8 weeks. Randomization will be stratified based on previous exposure to anti-tumor necrosis factor (TNF) agents such that at least 50% of the randomized subjects will be anti-TNF naïve .

The study will consist of 3 phases:

• screening phase: up to 4 weeks
• double-blind placebo-controlled phase treatment: 8 weeks
• post-treatment follow-up: 2 weeks

Eligible subjects will be randomized at Week 0 (Study Day 1) to either LYC-30937-EC 25 mg or placebo. Screening will occur from Study Days -28 to -1. Randomization and first dosing will occur at Week 0/Study Day 1. Double-blind study visits will occur at Weeks 2, 4, and 8, with the last dose at Week 8/Study Day 57. Subjects will return at Week 10 for a post-treatment safety follow-up visit.

Conditions

Colitis, Ulcerative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LYC-30937-EC 25 mg PO QD

LYC-30937-EC 25 mg by mouth once daily for 8 weeks

Group Type: EXPERIMENTAL

LYC-30937-EC

Intervention Type: DRUG

Placebo PO QD

Matching placebo by mouth once daily for 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

LYC-30937-EC

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Clinical UC diagnosis ≥ 6 months prior to screening with minimum disease extent of ≥ 15cm from anal verge.
• Active UC defined as a TMS of 4-11 (inclusive) with endoscopic subscore of ≥ 2 and rectal bleeding subscore of ≥ 1 at screening.
• Females of childbearing potential must have a negative pregnancy test at screening and baseline visits and must agree to use acceptable methods of birth control while in the trial and for 30 days after taking the last dose of study drug.
• May be currently receiving treatment with oral aminosalicylates (ASA) for ≥ 6 weeks at a stable dose for ≥ 3 weeks prior to the screening screening endoscopy and/or thiopurine at a stable dose ≥ 8 weeks prior to the screening endoscopy and/or prednisone (dose 20 mg daily) or equivalent for ≥ 4 weeks and receiving stable dose for ≥ 2 weeks prior to screening endoscopy
• able to provide written informed consent and be compliant with study procedures.

Exclusion Criteria

• History of Crohn's disease (CD) or indeterminate colitis or the presence or history of fistula consistent with CD.
• Presence of colon polyps.
• Severe extensive disease that in the investigators discretion is likely to require colonic surgery during the 8 week double-blind portion of the trial (eg, fulminant colitis, toxic megacolon, bowel perforation, evidence of acute abdomen).
• History of alcohol or drug abuse within 1 year of randomization.
• History of cancer including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been adequately treated with no recurrence for ≥ 1 year prior to screening.
• History or currently active primary or secondary immunodeficiency.
• Clinically relevant hepatic, neurologic, pulmonary, ophthalmological, gastrointestinal, endocrine, psychiatric, or other major systemic disease making implementation of the study difficult or that would put the subject at risk by participating in the study
• Positive test for Clostridium difficile or positive stool culture for enteric pathogens or presence of ova or parasites at screening.
• Liver function tests > 1.5 x upper limit of normal (ULN) or direct bilirubin > 1.5 x ULN
• Hemoglobin < 8.5 g/dl
• Neutrophils < 1500/mm3
• White blood cell (WBC) count < 3000/mm3
• Platelets < 80000 mm3
• International normalized ratio (INR) > 1.5
• Treatment with an immunosuppressant agent within 8 weeks of screening.
• Previous exposure to ≥ 2 approved or investigational biologic agents to treat UC.
• History of UC treatment with a biologic agent within 12 weeks of screening.
• Treatment with rectal steroids within 2 weeks of screening.
• Treatment with an investigational agent within 30 days of screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lycera Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

H. Jeffrey Wilkins, MD

Role: STUDY_DIRECTOR

Lycera Corp.

Locations

Lycera Investigational Site

Little Rock, Arkansas, United States

Lycera Investigational Site

Long Beach, California, United States

Lycera Investigational Site

Mission Hills, California, United States

Lycera Investigational Site

Rialto, California, United States

Lycera Investigational Site

Hollywood, Florida, United States

Lycera Investigational Site

Miami, Florida, United States

Lycera Investigational Site

Decatur, Georgia, United States

Lycera Investigational Site

Marietta, Georgia, United States

Lycera Investigational Site

Chicago, Illinois, United States

Lycera Investigational Site

Louisville, Kentucky, United States

Lycera Investigational Site

Baton Rouge, Louisiana, United States

Lycera Investigational Site

Ann Arbor, Michigan, United States

Lycera Investigational Site

Brooklyn, New York, United States

Lycera Investigational Site

New York, New York, United States

Lycera Investigational Site

The Bronx, New York, United States

Lycera Investigational Site

Greenville, North Carolina, United States

Lycera Investigational Site

Flourtown, Pennsylvania, United States

Lycera Investigational Site

Philadelphia, Pennsylvania, United States

Lycera Investigational Site

Sayre, Pennsylvania, United States

Lycera Investigational Site

Nashville, Tennessee, United States

Lycera Investigational Site

Union City, Tennessee, United States

Lycera Investigational Site.

Houston, Texas, United States

Lycera Investigational Sites

Houston, Texas, United States

Lycera Investigational Site

Houston, Texas, United States

Lycera Investigational Site

Houston, Texas, United States

Lycera Investigational Site

San Antonio, Texas, United States

Lycera Investigational Site

Victoria, British Columbia, Canada

Lycera Investigational Site

Toronto, Ontario, Canada

Lycera Investigational Site

Ostrava, , Czechia

Lycera Investigational Site

Prague, , Czechia

Lycera Investigational Site

Slaný, , Czechia

Lycera Investigational Site

Ústí nad Labem, , Czechia

Lycera Investigational Site

Budapest, , Hungary

Lycera Investigational Site

Budapest, , Hungary

Lycera Investigational Site

Debrecen, , Hungary

Lycera Investigational Site

Debrecen, , Hungary

Lycera Investigational Site

Hatvan, , Hungary

Lycera Investigational Site

Amsterdam, , Netherlands

Lycera Investigational Site

Rotterdam, , Netherlands

Lycera Investigational Site

Bydgoszcz, , Poland

Lycera Investigational Site

Bydgoszcz, , Poland

Lycera Investigational Site

Katowice, , Poland

Lycera Investigational Site

Katowice, , Poland

Lycera Investigational Site

Katowice, , Poland

Lycera Investigational Site

Kielce, , Poland

Lycera Investigational Site

Krakow, , Poland

Lycera Investigational Site

Krakow, , Poland

Lycera Investigational Site

Ksawerów, , Poland

Lycera Investigational Site

Lodz, , Poland

Lycera Investigational Site

Lublin, , Poland

Lycera Investigational Site

Lublin, , Poland

Lycera Investigational Site

Nowa Sól, , Poland

Lycera Investigational Site

Piaseczno, , Poland

Lycera Investigational Site

Poznan, , Poland

Lycera Investigational Site

Skierniewice, , Poland

Lycera Investigational Site

Sopot, , Poland

Lycera Investigational Site

Staszów, , Poland

Lycera Investigational Site

Szczecin, , Poland

Lycera Investigational Site

Warsaw, , Poland

Lycera Investigational Site

Warsaw, , Poland

Lycera Investigational Site

Wroclaw, , Poland

Lycera Investigational Site

Wroclaw, , Poland

Lycera Investigational Site

Wroclaw, , Poland

Lycera Investigational Site

Wroclaw, , Poland

Lycera Investigational Site

Włocławek, , Poland

Lycera Investigational Site

Belgrade, , Serbia

Lycera Investigational Site

Belgrade, , Serbia

Lycera Investigational Site

Kragujevac, , Serbia

Lycera Investigational Site

Niš, , Serbia

Lycera Investigational Site

Subotica, , Serbia

Lycera Investigational Site

Zrenjanin, , Serbia

Countries

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

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-000518-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LYC-30937-2001

Identifier Type: -

Identifier Source: org_study_id