Trial Outcomes & Findings for An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (NCT NCT03650413)
NCT ID: NCT03650413
Last Updated: 2023-09-29
Results Overview
Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Scale (NCI CTCAE v4.0)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
143 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2023-09-29
Participant Flow
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.
This is a single-arm open-label extension study. There is only one arm.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
143
|
|
Overall Study
COMPLETED
|
82
|
|
Overall Study
NOT COMPLETED
|
61
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
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
An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
Baseline characteristics by cohort
| Measure |
UTTR1147A
n=143 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
135 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
41.5 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
142 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
142 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: 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.
Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Scale (NCI CTCAE v4.0)
Outcome measures
| Measure |
UTTR1147A
n=128 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events
Serious Adverse Events, Fatal SAEs and SAEs Related to Study Medication
|
9 Participants
|
|
Number of Participants With Adverse Events
Non-Serious Adverse Events Reported
|
52 Participants
|
Adverse Events
UTTR1147A 60
Serious events: 9 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
UTTR1147A 60
n=128 participants at risk
Participants received treatment with UTTR1147A until clinical remission was achieved.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.78%
1/128 • Number of events 1 • From baseline up to 2 years
The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.There was only one arm of this study, however there was a subset of patients who received the IMP. This subset is defined here as the safety evaluable population.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.78%
1/128 • Number of events 1 • From baseline up to 2 years
The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.There was only one arm of this study, however there was a subset of patients who received the IMP. This subset is defined here as the safety evaluable population.
|
|
Eye disorders
Cataract
|
0.78%
1/128 • Number of events 1 • From baseline up to 2 years
The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.There was only one arm of this study, however there was a subset of patients who received the IMP. This subset is defined here as the safety evaluable population.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.6%
2/128 • Number of events 2 • From baseline up to 2 years
The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.There was only one arm of this study, however there was a subset of patients who received the IMP. This subset is defined here as the safety evaluable population.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.78%
1/128 • Number of events 1 • From baseline up to 2 years
The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.There was only one arm of this study, however there was a subset of patients who received the IMP. This subset is defined here as the safety evaluable population.
|
|
Infections and infestations
Clostridium difficile infection
|
0.78%
1/128 • Number of events 1 • From baseline up to 2 years
The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.There was only one arm of this study, however there was a subset of patients who received the IMP. This subset is defined here as the safety evaluable population.
|
|
Investigations
Amylase increased
|
1.6%
2/128 • Number of events 2 • From baseline up to 2 years
The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.There was only one arm of this study, however there was a subset of patients who received the IMP. This subset is defined here as the safety evaluable population.
|
|
Investigations
Lipase increased
|
2.3%
3/128 • Number of events 4 • From baseline up to 2 years
The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.There was only one arm of this study, however there was a subset of patients who received the IMP. This subset is defined here as the safety evaluable population.
|
|
Vascular disorders
Venous thrombosis limb
|
0.78%
1/128 • Number of events 1 • From baseline up to 2 years
The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.There was only one arm of this study, however there was a subset of patients who received the IMP. This subset is defined here as the safety evaluable population.
|
Other adverse events
| Measure |
UTTR1147A 60
n=128 participants at risk
Participants received treatment with UTTR1147A until clinical remission was achieved.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.7%
15/128 • Number of events 16 • From baseline up to 2 years
The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.There was only one arm of this study, however there was a subset of patients who received the IMP. This subset is defined here as the safety evaluable population.
|
|
Infections and infestations
COVID-19
|
7.8%
10/128 • Number of events 11 • From baseline up to 2 years
The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.There was only one arm of this study, however there was a subset of patients who received the IMP. This subset is defined here as the safety evaluable population.
|
|
Nervous system disorders
Headache
|
6.2%
8/128 • Number of events 10 • From baseline up to 2 years
The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.There was only one arm of this study, however there was a subset of patients who received the IMP. This subset is defined here as the safety evaluable population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
23.4%
30/128 • Number of events 45 • From baseline up to 2 years
The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.There was only one arm of this study, however there was a subset of patients who received the IMP. This subset is defined here as the safety evaluable population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
8/128 • Number of events 13 • From baseline up to 2 years
The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.There was only one arm of this study, however there was a subset of patients who received the IMP. This subset is defined here as the safety evaluable population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER