Plaque Psoriasis
Conditions
Brief summary
An open label, safety study to assess the potential for adrenal suppression following maximal use treatment with DSXS administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.
Detailed description
1. The objective of this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe plaque psoriasis 2. To evaluate the efficacy parameters, pharmacokinetics and adverse event (AE) profile of DSXS
Interventions
DRUGDSXS
twice daily for 28 days
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with a confirmed diagnosis of plaque psoriasis, patients 2-17 years of age with ≥ 10% BSA affected and patients age 18 years of age or older with ≥ 20% BSA affected 2. Investigator Global Assessment (IGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity. 3. Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response
Exclusion criteria
1. Patients under 2 years of age. 2. Investigator Global Assessment (IGA) of less than 3 (moderate) or greater than 4 (severe) at baseline. 3. Current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e., erythrodermic, exfoliative or pustular psoriasis). 4. Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With HPA Axis Suppression | 28 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| 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 | 1 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Enrolled in Error | 1 | 0 |
Baseline characteristics
| Characteristic | DSXS1503 Cohort 2 | DSXS1503 Cohort 1 | Total |
|---|---|---|---|
| Age, Continuous | 17.00 years | 56.72 years STANDARD_DEVIATION 12.9 | 55.19 years STANDARD_DEVIATION 14.85 |
| Baseline IGA Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline IGA Mild | 0 Participants | 0 Participants | 0 Participants |
| Baseline IGA Minimal | 0 Participants | 0 Participants | 0 Participants |
| Baseline IGA Moderate | 1 Participants | 20 Participants | 21 Participants |
| Baseline IGA Severe | 0 Participants | 5 Participants | 5 Participants |
| Baseline Total BSA | 1.83 meters squared | 2.11 meters squared STANDARD_DEVIATION 0.3 | 2.10 meters squared STANDARD_DEVIATION 0.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 25 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 24 Participants | 25 Participants |
| Sex: Female, Male Female | 1 Participants | 10 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 15 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 1 |
| other Total, other adverse events | 7 / 25 | 0 / 1 |
| serious Total, serious adverse events | 0 / 25 | 0 / 1 |
Outcome results
Primary
Number of Participants With HPA Axis Suppression
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.
Time frame: 28 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSXS1503 Cohort 1 | Number of Participants With HPA Axis Suppression | Yes | 3 Participants |
| DSXS1503 Cohort 1 | Number of Participants With HPA Axis Suppression | No | 21 Participants |
| DSXS1503 Cohort 2 | Number of Participants With HPA Axis Suppression | Yes | 0 Participants |
| DSXS1503 Cohort 2 | Number of Participants With HPA Axis Suppression | No | 1 Participants |