Adrenal Suppression and Pharmacokinetics of Topicort� Spray, 0.25% in Pediatric Patients With Plaque Psoriasis

Condition(s) targeted: Plaque Psoriasis

Intervention: Topicort® (desoximetasone) Topical Spray, 0.25% (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Taro Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Natalie Yantovskiy, Study Director, Affiliation: Taro Pharmaceuticals USA Inc

Overall contact:
Taro Pharmaceuticals U.S.A., Inc., Phone: 914-345-9001

The objective of this study is to evaluate the potential of Topicort® (desoximetasone) Topical Spray, 0. 25% to suppress hypothalmic pituitary adrenal axis function. The secondary objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event profile.

Official title: An Open Label, Safety Study to Assess the Potential for Adrenal Suppression and Pharmacokinetics Following Maximal Use Treatment With Topicort® (Desoximetasone) Topical Spray, 0.25% in Pediatric Patients With Plaque Psoriasis.

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Hypothalmic pituitary adrenal axis function suppression as measured by Cortisol Response Test

Secondary outcome:

Evaluate efficacy parameters as measured by change from baseline in clinical signs and symptoms (erythema, scaling, plaque elevation) and the PGA score at baseline and end of treatment

Evaluate pharmacokinetics as measured by Cmax-ss

Evaluate pharmacokinetics as measured by Tmax-ss

Evaluate pharmacokinetics as measured by Kel

Evaluate pharmacokinetics as measured by AUCss

Evaluate pharmacokinetics as measured by T½

Evaluate adverse event profile

Detailed description: An open label, post marketing safety study to assess the potential of a TOPICORT® (desoximetasone) Topical Spray, 0. 25% to suppress HPA axis function following twice daily dosing for 28 days. Up to one hundred (100) patients 2-17 years of age with a confirmed diagnosis of moderate to severe plaque psoriasis with involvement of ≥ 10% of their body surface area (excluding face and scalp). The participants will be serially enrolled into 3 cohorts. Cohort 1: 12 years to 17 years and 11 months of age (up to 20-40 subjects) Cohort 2: 6 years to 11 years and 11 months of age (up to 20-30 subjects) Cohort 3: 2 years to 5 years and 11 months of age (up to 10-30 subjects) Approximately 12 patients from each cohort will be included in a subgroup for PK profile determination. To minimize blood collection in young subjects in Cohorts 2 and 3 more sparse samplings may be done with lower age groups based on the PK profiles observed in Cohort 1. Prior to Cohort 2, all PK data from Cohort 1 will be analyzed and the protocol will be amended and submitted for IRB approval. The same procedure will be followed to analyze Cohort 2 data prior to Cohort 3. If during the study more than 35% of dosed subjects from each cohort are considered to be exhibiting signs (confirmed by the results of a cortisol response test) and/or symptoms (nausea, headache, fatigue, myalgia or loose stool) of HPA axis suppression, the enrollment for this cohort will be stopped and the enrollment for a younger cohort(s) will not be initiated. A patient will be considered to have potential HPA axis suppression if they meet at least one of the criteria:

- their 30 minute post injection cortisol level is not at least 7 mcg/100 ml greater than

the basal level (< basal + 7)

- the post stimulation level is ≤ 18 mcg/100 ml

Minimum age: 2 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients aged 7 years and older must have provided written assent accompanied by

written informed consent from patient's representative

- Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface

area (excluding face and scalp)

- Physicians Global Assessment score of 3 or 4 at baseline

Exclusion Criteria:

- Has other dermatological conditions that may interfere with clinical assessments

- Allergy or sensitivity to corticosteroids or any drug hypersensitivity or intolerance

that would compromise patient safety or study results

- History of an adverse reaction to Cortrosynâ„¢ or similar test reagents

- Chronic infectious disease, system or organ disorder or other medical condition that

would place patient at undue risk by study participation

Taro Pharmaceuticals U.S.A., Inc., Phone: 914-345-9001

Taro Pharmaceuticals USA Inc., Hawthorne, New York 10532, United States; Recruiting
Natalie Yantovskiy

Starting date: December 2014
Last updated: January 12, 2015