Ulcerative Colitis, Crohn's Disease
Conditions
Brief summary
This study will evaluate the long-term safety and tolerability of UTTR1147A in participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), enrolling up to 320 participants from the parent studies: Phase Ib Study GA29469 (NCT02749630) and Phase II Study GA39925 (NCT03558152).
Interventions
DRUGUTTR1147A
UTTR1147A will be administered based on disease status, as described in the protocol.
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria for Study Entry: * Prior enrollment in Study GA29469 or Study GA39925 and meeting protocol defined entry criteria Inclusion Criteria for Study Entry and Study Re-Entry: * Ability to comply with requirements of the study, in the investigator's judgment * For women and men: use of highly effective contraception as defined by the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Up to 2 years | Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Scale (NCI CTCAE v4.0) |
Countries
Bulgaria, Georgia, Germany, Greece, Ireland, Italy, Moldova, Poland, Russia, Serbia, Spain, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
All 143 patients were included in the intent-to-treat (ITT) population, with 128 patients allocated to study treatment and 15 patients that were not treated.
Pre-assignment details
This is a single-arm open-label extension study. There is only one arm.
Participants by arm
| Arm | Count |
|---|---|
| UTTR1147A Participants enrolled in the extension study either received efmarodocokin alfa treatment (60 μg/kg intravenously \[IV\] every 4 weeks \[Q4W\]) or if they were in remission, underwent observation for up to 2 years (through Week 104), as determined based on the patient's disease status at the time of their last endoscopy in the parent study. | 143 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 17 |
| Overall Study | Other | 9 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Study Terminated By Sponsor | 16 |
| Overall Study | Withdrawal by Subject | 16 |
Baseline characteristics
| Characteristic | UTTR1147A |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 135 Participants |
| Age, Continuous | 41.5 Years STANDARD_DEVIATION 12.4 |
| Race/Ethnicity, Customized Not Hispanic or Latino | 142 Participants |
| Race/Ethnicity, Customized Not Stated | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 142 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 128 |
| other Total, other adverse events | 52 / 128 |
| serious Total, serious adverse events | 9 / 128 |
Outcome results
Primary
Number of Participants With Adverse Events
Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Scale (NCI CTCAE v4.0)
Time frame: Up to 2 years
Population: The safety-evaluable population comprised 128 patients who received at least one dose of the study drug. There was only 1 arm in this open label extension study. Treatment was available to all study participants if they lost remission.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UTTR1147A | Number of Participants With Adverse Events | Serious Adverse Events, Fatal SAEs and SAEs Related to Study Medication | 9 Participants |
| UTTR1147A | Number of Participants With Adverse Events | Non-Serious Adverse Events Reported | 52 Participants |