A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-003633-26-PL
• Lead Sponsor: ycera Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-27
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.Completed the 8-week double-blind treatment period of study LYC-30937-2001.
2.Males and females of childbearing potential must agree to use adequate birth control measures during the study. Female subjects of child bearing potential must use 2 highly effective forms of contraception, unless surgically sterilized, partner has had a vasectomy, or they will be abstinent during study participation and for 30 days after their last dose of study drug. Highly effective methods of birth control in this study include: intrauterine device, hormonal contraceptives, (oral, patch, long acting injectable, implant), double-barrier method (condom or diaphragm with spermicide).
3.Non-pregnant, non-lactating females who are not planning to become pregnant while enrolled in this study.
4.Investigator considers it safe and potentially beneficial to participate.
5.Ability to provide written informed consent and to be compliant with the schedule of events.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified