Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis

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.

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: DSXS

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

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Hawthorne, New York, United States, 10532
      • Taro Pharmaceuticals USA Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DSXS1503; administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.	Drug: DSXS; twice daily for 28 days; Other Names: Active

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2015
• Primary Completion (Actual): December 29, 2016
• Study Completion (Actual): August 25, 2017

Study Registration Dates

• First Submitted: November 1, 2015
• First Submitted That Met QC Criteria: November 8, 2015
• First Posted (Estimate): November 10, 2015

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: DSXS 1503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO