Back to resultsStudy to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DSXS
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis
Eligibility Criteria
Inclusion Criteria:
- 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
- Investigator Global Assessment (IGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.
- Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response
Exclusion Criteria:
- Patients under 2 years of age.
- Investigator Global Assessment (IGA) of less than 3 (moderate) or greater than 4 (severe) at baseline.
- Current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e., erythrodermic, exfoliative or pustular psoriasis).
- Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response
Sites / Locations
- Taro Pharmaceuticals USA Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DSXS1503
Arm Description
administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02601469
First Posted
November 1, 2015
Last Updated
December 5, 2018
Sponsor
Taro Pharmaceuticals USA
1. Study Identification
Unique Protocol Identification Number
NCT02601469
Brief Title
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis
Official Title
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients With Plaque Psoriasis.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 4, 2015 (Actual)
Primary Completion Date
December 29, 2016 (Actual)
Study Completion Date
August 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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
To evaluate the efficacy parameters, pharmacokinetics and adverse event (AE) profile of DSXS
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DSXS1503
Arm Type
Experimental
Arm Description
administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.
Intervention Type
Drug
Intervention Name(s)
DSXS
Other Intervention Name(s)
Active
Intervention Description
twice daily for 28 days
Primary Outcome Measure Information:
Title
Number of Participants With HPA Axis Suppression
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Investigator Global Assessment (IGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.
Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response
Exclusion Criteria:
Patients under 2 years of age.
Investigator Global Assessment (IGA) of less than 3 (moderate) or greater than 4 (severe) at baseline.
Current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e., erythrodermic, exfoliative or pustular psoriasis).
Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novum Pharmaceutical Research Services
Organizational Affiliation
http://www.novumprs.com/contact
Official's Role
Study Chair
Facility Information:
Facility Name
Taro Pharmaceuticals USA Inc.
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis
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