Trial Outcomes & Findings for Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis (NCT NCT02601469)
NCT ID: NCT02601469
Last Updated: 2018-12-07
Results Overview
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
28 days
Results posted on
2018-12-07
Participant Flow
Participant milestones
| Measure |
DSXS1503 Cohort 1
Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 19 years and older.
DSXS: twice daily for 28 days
|
DSXS1503 Cohort 2
Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 16-18 years of age.
DSXS: twice daily for 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
1
|
|
Overall Study
COMPLETED
|
24
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
DSXS1503 Cohort 1
Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 19 years and older.
DSXS: twice daily for 28 days
|
DSXS1503 Cohort 2
Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 16-18 years of age.
DSXS: twice daily for 28 days
|
|---|---|---|
|
Overall Study
Enrolled in Error
|
1
|
0
|
Baseline Characteristics
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
DSXS1503 Cohort 1
n=25 Participants
Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 19 years and older.
DSXS: twice daily for 28 days
|
DSXS1503 Cohort 2
n=1 Participants
Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 16-18 years of age.
DSXS: twice daily for 28 days
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.72 years
STANDARD_DEVIATION 12.90 • n=5 Participants
|
17.00 years
n=7 Participants
|
55.19 years
STANDARD_DEVIATION 14.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Total BSA
|
2.11 meters squared
STANDARD_DEVIATION 0.30 • n=5 Participants
|
1.83 meters squared
n=7 Participants
|
2.10 meters squared
STANDARD_DEVIATION 0.30 • n=5 Participants
|
|
Baseline IGA
Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline IGA
Minimal
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline IGA
Mild
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline IGA
Moderate
|
20 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Baseline IGA
Severe
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysHypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml.
Outcome measures
| Measure |
DSXS1503 Cohort 1
n=24 Participants
Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 19 years and older.
DSXS: twice daily for 28 days
|
DSXS1503 Cohort 2
n=1 Participants
Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 16-18 years of age.
DSXS: twice daily for 28 days
|
|---|---|---|
|
Number of Participants With HPA Axis Suppression
Yes
|
3 Participants
|
0 Participants
|
|
Number of Participants With HPA Axis Suppression
No
|
21 Participants
|
1 Participants
|
Adverse Events
DSXS1503 Cohort 1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
DSXS1503 Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DSXS1503 Cohort 1
n=25 participants at risk
Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 19 years and older.
DSXS: twice daily for 28 days
|
DSXS1503 Cohort 2
n=1 participants at risk
Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 16-18 years of age.
DSXS: twice daily for 28 days
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
1/25 • Number of events 1 • 1 year, 4 months
|
0.00%
0/1 • 1 year, 4 months
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
1/25 • Number of events 1 • 1 year, 4 months
|
0.00%
0/1 • 1 year, 4 months
|
|
General disorders
Application site irritation
|
4.0%
1/25 • Number of events 1 • 1 year, 4 months
|
0.00%
0/1 • 1 year, 4 months
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
1/25 • Number of events 1 • 1 year, 4 months
|
0.00%
0/1 • 1 year, 4 months
|
|
Investigations
ACTH stimulation test abnormal
|
4.0%
1/25 • Number of events 1 • 1 year, 4 months
|
0.00%
0/1 • 1 year, 4 months
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
4.0%
1/25 • Number of events 1 • 1 year, 4 months
|
0.00%
0/1 • 1 year, 4 months
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Number of events 1 • 1 year, 4 months
|
0.00%
0/1 • 1 year, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
1/25 • Number of events 1 • 1 year, 4 months
|
0.00%
0/1 • 1 year, 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place