Ulcerative Colitis
Conditions
Interventions
Subjects will receive LYC-30937-EC 25 mg once daily [q.d.].
Ulcerative Colitis
Sponsors
Lycera Corp.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exploratory Efficacy Endpoints: - The change in Mayo stool frequency subscore at weeks 4, 8, 20, 32 and 44 as compared to the study LYC-30937-2001 Week 8 stool frequency subscore - The change in Mayo rectal bleeding subscore at weeks 4, 8, 20, 32 and 44 as compared to the study LYC-30937-2001 Week 8 rectal bleeding subscore | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Endpoint The incidence and type of AEs, SAEs, and AEs that led to discontinuation of treatment, laboratory assessments, vital sign measurements, ECGs, and PEs. | — |
Countries
The Netherlands
Outcome results
None listed