Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06

Primus Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Psoriasis

Treatments

Drug: DFD06

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03179605

DFD-06-CD-011

Details and patient eligibility

About

The purpose of this study is to evaluate the potential of DFD-06 to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days.

Full description

This is a 15-day, single arm, multicenter, multi-dose, open-label, two stage, sequential study. In the first stage, subjects who are at least 12 years of age and not more than 16.9 years (16 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects). In the second stage subjects who are at least 6 years of age and not more than 11.9 years (11 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects). An attempt will be made to enroll subjects throughout the age range of each cohort including the lower age range. DFD-06 will be applied twice daily to all affected areas on the body excluding face, scalp, groin, axillae and other intertriginous areas. Subjects must have ≥10% Body Surface Area (BSA) treated to achieve maximal use exposure.

Enrollment

22 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects and the parent or legal guardian understand the study procedures and agree to participate by giving assent and written informed consent, respectively. Subject's parent or legal guardian must be willing to authorize use and disclosure of protected health information collected for the study.
Subjects must be at least 6 years and not more than 16.9 years of age, with body weight greater than or equal to 45 pounds at Screening.
Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
Subjects with psoriasis involving ≥10% Body Surface Area (BSA), not including the face, scalp, groin, axillae and other intertriginous areas at the Baseline Visit.
Subjects must have an Investigator Global Assessment (IGA) grade of at least 3 (moderate) at the Baseline Visit.

Exclusion criteria

Subject has a current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
Subject has a history of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
Subject has received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the Baseline Visit.
Subject has a history or presence of intracranial hypertension.
Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or is intending to have such exposure during the study that is thought by the investigator to likely modify the subject's disease