Trial Outcomes & Findings for Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients With Active Skin Extra-intestinal Manifestations (NCT NCT03139032)
NCT ID: NCT03139032
Last Updated: 2020-12-31
Results Overview
Only if there are signs of inflammation at screening another evaluation was planned to be performed at week 12.
TERMINATED
PHASE2
1 participants
Weeks 12
2020-12-31
Participant Flow
Participant milestones
| Measure |
Etrasimod
Participants received active treatment for 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients With Active Skin Extra-intestinal Manifestations
Baseline characteristics by cohort
| Measure |
Etrasimod
n=1 Participants
Participants received active treatment for 12 weeks.
|
|---|---|
|
Age, Customized
Between 18 to 80 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
NA Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
NA Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
NA Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 12Population: Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported.
Only if there are signs of inflammation at screening another evaluation was planned to be performed at week 12.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weeks 4, 8, and 12Population: Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weeks 2, 4, 8, and 12Population: Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weeks 1, 2, 4, 8, 12 and the 2-week follow-up visitPopulation: Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weeks 8 and 12Population: Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weeks -1, 8, and 12.Population: Efficacy analyses were not conducted due to low enrollment (N=1). To protect participant's privacy, the results from a single participant cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Weeks -1, 8 and 12.Population: Efficacy analyses were not conducted due to low enrollment (N=1). In order to protect participant's privacy, the results from a single participant cannot be reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of first dose of study treatment to the safety follow-up visit, approximately 14 weeksPopulation: There were no analysis populations in the single participant study. Safety results for the single participant are reported.
Planned safety evaluations included clinical laboratory tests (chemistry, hematology, and urinalysis), vital signs (blood pressure, pulse, respiratory rate, and oral temperature), physical examination (assessment of general appearance, skin, head \[eyes, ears, nose and throat\], neck, thyroid, lungs, heart, abdomen, back, lymph nodes, and extremities, and body weight), 12-lead electrocardiograms, adverse event reporting, concomitant medication, and lymphocyte counts.
Outcome measures
| Measure |
Etrasimod
n=1 Participants
Participants received active treatment for 12 weeks.
|
|---|---|
|
Safety Measured by Number of Participants With Adverse Events and Serious Adverse Events
|
0 Participants
|
Adverse Events
Etrasimod
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Head of Document Operations
Arena Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER