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Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis

Primary Purpose

Colitis, Ulcerative

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LYC-30937-EC
Sponsored by
Lycera Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Completed the 8-week double-blind treatment period of study LYC-30937-2001
  • Male and females of childbearing potential must agree to use adequate birth control during the study and for 30 days after discontinuing study drug
  • Non-pregnant, non-lactating females who are not planning to become pregnant while enrolled in this study
  • Investigator considers it safe and potentially beneficial to participate
  • Ability to provide written informed consent and to be compliant with study schedule

Exclusion Criteria:

  • Subjects who completed study LYC-30937-2001, but who experienced a serious adverse event that was considered related to investigational product, has an unstable medical condition, or for any other reason in the opinion of the investigator should not participate in this study

Sites / Locations

  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera investigational site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera investigational site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site
  • Lycera Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LYC-30937-EC

Arm Description

LYC-30937-EC 25 mg by mouth once daily

Outcomes

Primary Outcome Measures

Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment
Adverse events (AEs) were collected from the time a subject signed the informed consent and completed participation in the preceding double-blind trial LYC-30937-2001. Treatment-emergent adverse events (TEAEs) are AEs occurring or worsening after the first dose of study drug (LYC-30937-EC 25 mg). Adverse event severity was assessed by the Investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03, with grading as follows: Grade 1 = mild (asymptomatic or mild symptoms), Grade 2 = moderate (minimal, local intervention, or noninvasive intervention indicated); Grade 3 = severe (or medically significant but not life-threatening); Grade 4 = life-threatening; Grade 5 = death.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2016
Last Updated
March 5, 2019
Sponsor
Lycera Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT02764229
Brief Title
Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis
Official Title
A Multicenter Open-label Extension Study to Assess the Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy of test drug
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
July 18, 2018 (Actual)
Study Completion Date
July 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lycera Corp.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to allow subjects completing study LYC-30937-2001 the opportunity to receive LYC-30937-EC 25 mg.
Detailed Description
Subjects who complete the 8 week treatment period of the double-blind, placebo-controlled study LYC-30937-2001 will have the option of receiving LYC-30397-EC 25 mg PO QD in this open-label extension study (LYC-30937-2002). Subjects meeting eligibility criteria will enter this open-label extension trial upon completion of the LYC-30937-2001 Week 8 study procedures. This open-label extension study will consist of 44 weeks of treatment followed by a 2 weeks post-treatment follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LYC-30937-EC
Arm Type
Experimental
Arm Description
LYC-30937-EC 25 mg by mouth once daily
Intervention Type
Drug
Intervention Name(s)
LYC-30937-EC
Intervention Description
LYC-30937-EC 25 mg by mouth once daily
Primary Outcome Measure Information:
Title
Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment
Description
Adverse events (AEs) were collected from the time a subject signed the informed consent and completed participation in the preceding double-blind trial LYC-30937-2001. Treatment-emergent adverse events (TEAEs) are AEs occurring or worsening after the first dose of study drug (LYC-30937-EC 25 mg). Adverse event severity was assessed by the Investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03, with grading as follows: Grade 1 = mild (asymptomatic or mild symptoms), Grade 2 = moderate (minimal, local intervention, or noninvasive intervention indicated); Grade 3 = severe (or medically significant but not life-threatening); Grade 4 = life-threatening; Grade 5 = death.
Time Frame
46 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed the 8-week double-blind treatment period of study LYC-30937-2001 Male and females of childbearing potential must agree to use adequate birth control during the study and for 30 days after discontinuing study drug Non-pregnant, non-lactating females who are not planning to become pregnant while enrolled in this study Investigator considers it safe and potentially beneficial to participate Ability to provide written informed consent and to be compliant with study schedule Exclusion Criteria: Subjects who completed study LYC-30937-2001, but who experienced a serious adverse event that was considered related to investigational product, has an unstable medical condition, or for any other reason in the opinion of the investigator should not participate in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Jeffrey Wilkins, MD
Organizational Affiliation
Lycera Corp.
Official's Role
Study Director
Facility Information:
Facility Name
Lycera Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Lycera Investigational Site
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Lycera Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Lycera Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Lycera Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Lycera investigational site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Lycera Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Lycera Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Lycera investigational site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Lycera Investigational Site
City
Ostrava
ZIP/Postal Code
722 00
Country
Czechia
Facility Name
Lycera Investigational Site
City
Praha 3
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
Lycera Investigational Site
City
Ústí Nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Lycera Investigational Site
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Lycera Investigational Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Lycera Investigational Site
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Lycera Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Lycera Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
Facility Name
Lycera Investigational Site
City
Katowice
ZIP/Postal Code
40-211
Country
Poland
Facility Name
Lycera Investigational Site
City
Katowice
ZIP/Postal Code
40-659
Country
Poland
Facility Name
Lycera Investigational Site
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Lycera Investigational Site
City
Kielce
ZIP/Postal Code
25-355
Country
Poland
Facility Name
Lycera Investigational Site
City
Kraków
ZIP/Postal Code
31-009
Country
Poland
Facility Name
Lycera Investigational Site
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Facility Name
Lycera Investigational Site
City
Piaseczno
ZIP/Postal Code
05-500
Country
Poland
Facility Name
Lycera Investigational Site
City
Poznań
ZIP/Postal Code
61-113
Country
Poland
Facility Name
Lycera Investigational Site
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Lycera Investigational Site
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Lycera Investigational Site
City
Staszów
ZIP/Postal Code
28-200
Country
Poland
Facility Name
Lycera Investigational Site
City
Szczecin
ZIP/Postal Code
71-270
Country
Poland
Facility Name
Lycera Investigational Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Lycera Investigational Site
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
Facility Name
Lycera Investigational Site
City
Wloclawek
ZIP/Postal Code
87-800
Country
Poland
Facility Name
Lycera Investigational Site
City
Wroclaw
ZIP/Postal Code
50-449
Country
Poland
Facility Name
Lycera Investigational Site
City
Wrocław
ZIP/Postal Code
53-333
Country
Poland
Facility Name
Lycera Investigational Site
City
Wrocław
Country
Poland
Facility Name
Lycera Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Lycera Investigational Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Lycera Investigational Site
City
Niš
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Lycera Investigational Site
City
Subotica
ZIP/Postal Code
24000
Country
Serbia
Facility Name
Lycera Investigational Site
City
Zrenjanin
ZIP/Postal Code
23000
Country
Serbia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis

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