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

Phase 2

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: DSXS

• Registration Number: NCT02601469
• Lead Sponsor: Taro Pharmaceuticals USA

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

Study Timeline

• Study Start: 2015-09-04
• Study First Submitted: 2015-11-01
• Study First Submitted QC: 2015-11-08
• Study First Posted: 2015-11-10
• Primary Completion: 2016-12-29
• Study Completion: 2017-08-25
• Results First Submitted: 2018-11-12
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-05
• Last Update Submitted: 2018-12-05
• Results First Posted: 2018-12-07
• Last Update Posted: 2018-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DSXS1503	DSXS	administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Taro Pharmaceuticals USA Inc.; 🇺🇸 Hawthorne, New York, United States