NCT03298581

Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Plaque Psoriasis

An Open-label Safety Study to Assess the Multiple-dose Pharmacokinetics and Potential for Adrenal Suppression Following Topical Treatment With Halobetasol Propionate 0.05% Topical Spray Applied Twice Daily for 28 Days in Patients With Moderate to Severe Plaque Psoriasis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and potential for adrenal suppression following topical treatment with halobetasol propionate 0.05% spray applied twice-daily in adult patients with moderate to severe plaque psoriasis. At least 40 eligible patients with plaque psoriasis that satisfy all eligibility criteria will be enrolled into the study

Detailed description

This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and potential for adrenal suppression following topical treatment with halobetasol propionate 0.05% spray applied twice-daily in adult patients with moderate to severe plaque psoriasis. At least 40 eligible patients with plaque psoriasis that satisfy all eligibility criteria will be enrolled into the study. Patients must be overall in good health and should have a current diagnosis of moderate to severe plaque psoriasis with Investigator Global Assessment (IGA) score of at least 3 or 4. Patients will be stratified by age with: Cohort 1: At least 20 patients 18 years of age and older with ≥ 20% body surface area (BSA) affected Cohort 2: At least 20 patients 12-16 years and 11 months of age with ≥ 10% BSA affected Cohort 2 will initiate enrollment once all enrolled patients in Cohort 1 have completed the study and a safety analysis has been reviewed by the Medical Monitor and approved by the Novum Independent Institutional Review Board (NIIRB). Sites will not begin enrollment of patients in Cohort 2 until the site is notified by email that the safety analysis for Cohort 1 has been reviewed and approved. Confirmation of email receipt will be required from each Investigator before enrollment of Cohort 2 can begin. Each cohort will be enrolled based on the availability of patients. Each cohort will be reviewed for the potential of HPA axis suppression. The Medical Monitor or NIIRB may discontinue the study at any time if safety concerns are found. If 6 or more patients in Cohort 1 experience HPA axis suppression, then enrollment for Cohort 1 will be stopped. Cohort 2 will not be initiated if 6 or more patients enrolled in Cohort 1 experience HPA axis suppression or 30% or more of the final enrolled number of patients in Cohort 1 experience HPA axis suppression. If 6 or more patients in Cohort 2 experience HPA axis suppression, then enrollment for Cohort 2 will be stopped. If the study is stopped at any time, patients currently enrolled will be contacted via phone and instructed to discontinue study product immediately. Patients will be instructed to return for their next scheduled visit for cortisol response testing. Sites will follow up with patients and monitor for HPA axis suppression. All patients will be followed until cortisol levels are normal. Patients will be instructed to apply topical spray twice daily onto the affected skin areas for 28 days. Patients will be instructed not to rub over the affected area after application of spray Patients will apply the morning dose of the study product in the clinic at each clinic visit and at home during non-clinic visits. A phone call will be made approximately 14 days after the patient has completed dosing to follow-up on any new adverse events that may have occurred

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Halobetasol Propionate	Experimental: Treatment with topical halobetasol spray 0.05% Patients will instructed o apply halobetasol spray twice daily for 28 days and not to rub over the affected area after application of spray.

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-01-31
• Completion: 2018-01-31
• First posted: 2017-10-02
• Last updated: 2021-06-14

Regulatory

• FDA-regulated drug study