Colitis, Ulcerative
Conditions
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.
Interventions
DRUGLYC-30937-EC
LYC-30937-EC 25 mg by mouth once daily
Sponsors
Lycera Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment | 46 weeks | 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. |
Countries
Czechia, Hungary, Netherlands, Poland, Serbia, United States
Participant flow
Recruitment details
Participants were enrolled at 40 study centers with the United States, Poland, Hungary, Czech Republic, Serbia and Netherlands. Study centers included academic medical centers and non-academic medical clinics.
Pre-assignment details
Eligible subjects were those completing the preceding double-blind study LYC-30937-2001 Week 8 visit.
Participants by arm
| Arm | Count |
|---|---|
| LYC-30937-EC LYC-30937-EC 25 mg by mouth once daily | 112 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Study Stopped by Sponsor | 69 |
| Overall Study | Withdrawal by Subject | 15 |
Baseline characteristics
| Characteristic | LYC-30937-EC |
|---|---|
| Age, Continuous | 41.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 109 Participants |
| Region of Enrollment Czechia | 4 subjects |
| Region of Enrollment Hungary | 2 subjects |
| Region of Enrollment Netherlands | 3 subjects |
| Region of Enrollment Poland | 76 subjects |
| Region of Enrollment Serbia | 5 subjects |
| Region of Enrollment United States | 22 subjects |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 111 |
| other Total, other adverse events | 18 / 111 |
| serious Total, serious adverse events | 6 / 111 |
Outcome results
Primary
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.
Time frame: 46 weeks
Population: Safety Set, consisting of all subjects who took at least 1 dose of study drug. 112 subjects signed consent to participate in the study and 111 of these were confirmed to have taken at least 1 dose of study drug. (One subject was lost to follow-up after enrolling and it was not confirmed that they took study drug.)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LYC-30937-EC | Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment | Subjects with ≥ 1 AE | 56 Participants |
| LYC-30937-EC | Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment | Subjects with ≥ 1 SAE | 6 Participants |
| LYC-30937-EC | Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment | Subjects with AE leading to discontinuation | 9 Participants |