Trial Outcomes & Findings for Efficacy and Safety of APD334 in Patients With Pyoderma Gangrenosum (NCT NCT03072953)
NCT ID: NCT03072953
Last Updated: 2021-06-11
Results Overview
The physician's global assessment for active skin manifestations recorded the number of ulcers, target lesion noted for endpoint evaluation, diameters of each target lesion and score of evaluation at each visit. The scores ranged from 0 (total resolution) to 4 (no evidence of healing).
TERMINATED
PHASE2
2 participants
Week 12
2021-06-11
Participant Flow
Participant milestones
| Measure |
APD334
During the 12-week treatment period, participants received etrasimod active treatment, administered orally, once daily.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of APD334 in Patients With Pyoderma Gangrenosum
Baseline characteristics by cohort
| Measure |
APD334
n=2 Participants
During the 12-week treatment period, participants received etrasimod active treatment, administered orally, once daily.
|
|---|---|
|
Age, Customized
Between 18 to 80 years
|
2 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
|
0 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
|
2 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
|
PRIMARY outcome
Timeframe: Week 12Population: Efficacy analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported.
The physician's global assessment for active skin manifestations recorded the number of ulcers, target lesion noted for endpoint evaluation, diameters of each target lesion and score of evaluation at each visit. The scores ranged from 0 (total resolution) to 4 (no evidence of healing).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 12Population: Efficacy analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported.
The patient global assessment for active skin manifestation recorded the disease and pain severity using a visual analogue to mark the participant's score. Participants were asked to rate their disease severity from "not severe" to "extremely severe" and pain levels from "no pain at all' to "worst pain imaginable" in the past one week.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 12Population: Efficacy analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported.
The DLQI questionnaire assessed how much a participant's life is affected through their skin problem in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure and sport activities, work or school activities, personal relationships and treatment- related feelings. Participants responded to the 10 questions on a scale from 0 (not at all) to 3 (very much) with a total score ranging from 0 to 30. Higher scores indicated that the skin problem had an extremely large effect on the participant's life whereas lower scores indicated that the disease has minimal to no effect at all.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 12Population: Efficacy analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 12Population: Efficacy analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported.
Changes in surface area
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 12Population: Efficacy analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported.
Changes in histology.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 12 weeksPopulation: All enrolled participants
Safety was assessed by monitoring and recording all adverse events, clinical laboratory tests (including hematology, serum chemistry, coagulation, and urinalysis), physical and neurological examinations, vital sign measurements, and 12-lead electrocardiograms. The number of participants with adverse events and CS safety measures have been reported.
Outcome measures
| Measure |
APD334
n=2 Participants
During the 12-week treatment period, participants received etrasimod active treatment, administered orally, once daily.
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|---|---|
|
Number of Participants With Adverse Events and Clinically Significant (CS) Safety Measurements
Adverse events
|
2 Participants
|
|
Number of Participants With Adverse Events and Clinically Significant (CS) Safety Measurements
CS clinical laboratory values
|
0 Participants
|
|
Number of Participants With Adverse Events and Clinically Significant (CS) Safety Measurements
CS physical & neurological examinations
|
0 Participants
|
|
Number of Participants With Adverse Events and Clinically Significant (CS) Safety Measurements
CS vital sign measurements
|
0 Participants
|
|
Number of Participants With Adverse Events and Clinically Significant (CS) Safety Measurements
CS 12-lead ECG measurements
|
0 Participants
|
Adverse Events
APD334
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
APD334
n=2 participants at risk
During the 12-week treatment period, participants received etrasimod active treatment, administered orally, once daily.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Up to approximately 12 weeks
|
|
Nervous system disorders
headache
|
50.0%
1/2 • Up to approximately 12 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
1/2 • Up to approximately 12 weeks
|
|
Injury, poisoning and procedural complications
Sore hip
|
50.0%
1/2 • Up to approximately 12 weeks
|
Additional Information
Arena CT.gov Administrator
Arena Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER