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

L

Lycera

Status and phase

Terminated
Phase 2

Conditions

Colitis, Ulcerative

Treatments

Drug: LYC-30937-EC

Study type

Interventional

Funder types

Industry

Identifiers

NCT02764229
LYC-30937-2002
2016-003633-26 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to allow subjects completing study LYC-30937-2001 the opportunity to receive LYC-30937-EC 25 mg.

Full 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.

Enrollment

112 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

112 participants in 1 patient group

LYC-30937-EC
Experimental group
Description:
LYC-30937-EC 25 mg by mouth once daily
Treatment:
Drug: LYC-30937-EC

Trial documents
1

Trial contacts and locations

40

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Data sourced from clinicaltrials.gov

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