Evaluation of Absorption, Systemic Pharmacokinetics, and HPA Axis Suppression of Topical Halobetasol Propionate in Pediatric Moderate to Severe Plaque Psoriasis

Trial ID: 2024-520058-39-00
Protocol: V01-122A-401
Sponsor: Bausch Health Americas Inc.

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Diseases & Conditions

Psoriasis

Objectives

The primary objective of this study is to evaluate the **safety** of IDP-122 (halobetasol propionate 0.01%) Lotion when administered topically once daily for 8 weeks in pediatric subjects with moderate to severe **plaque psoriasis**. This is clinically relevant as it assesses the potential adverse effects and overall tolerability of the treatment in a vulnerable population. Additionally, the study aims to determine the systemic exposure of halobetasol propionate after topical application of IDP-122 Lotion once daily for 4 weeks, which is crucial for understanding the pharmacokinetics and ensuring systemic safety. Another primary objective is to assess the potential for **hypothalamic-pituitary-adrenal (HPA) axis suppression** when the lotion is applied once daily for 8 weeks, which is important for evaluating the risk of systemic corticosteroid effects.

Participants

The clinical trial involves a total of **19 participants** diagnosed with **plaque psoriasis**. The study population comprises both male and female subjects, aged between **6 to 16 years and 11 months**. Participants are required to be in good general health, as determined by medical history, physical examination, and laboratory values within normal ranges. The selection process included obtaining verbal and written informed consent or assent from the subjects and their legal guardians. Participants must have a clinical diagnosis of psoriasis with an Investigator's Global Assessment score of 3 or 4, and a body surface area affected by plaque psoriasis of at least 10%, excluding the face, scalp, axillae, and intertriginous areas. Lifestyle considerations include the avoidance of prolonged exposure to ultraviolet radiation on the treatment area. Female participants of childbearing potential and pre-menses females aged 9 and older are required to have negative pregnancy tests and must practice effective contraception throughout the study duration. The trial does not involve a vulnerable population.

Plans and Procedures

The clinical trial is designed as an **open-label**, multicenter study to evaluate the absorption, systemic pharmacokinetics, and hypothalamic-pituitary-adrenal (HPA) axis suppression potential of topically applied IDP-122 Lotion in pediatric subjects with moderate to severe **plaque psoriasis**. The trial is categorized as a Phase 4 study, with a Phase 2 designation in the European Union, and is not considered a low-intervention trial. The study aims to assess the safety of IDP-122 Lotion, which contains **halobetasol propionate** as the active substance, when administered topically once daily for a period of 8 weeks. Additionally, the trial will evaluate the systemic exposure of halobetasol propionate after 4 weeks of application and the potential for HPA axis suppression over the 8-week treatment period.

The trial is expected to commence recruitment on September 1, 2020, and is estimated to conclude by May 31, 2025. Participants will be involved in the study for a maximum of 8 weeks, during which they will attend several study visits. The sequence of study visits includes an initial screening visit to confirm eligibility based on specific inclusion criteria, such as age, health status, and the extent of psoriasis involvement. Following the screening, participants will attend a baseline visit where the study drug will be first applied. Subsequent follow-up visits will occur at regular intervals to monitor safety, efficacy, and any potential adverse effects. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted.

Participants are expected to comply with study instructions and attend all scheduled visits. Conditions that may lead to early termination from the study include non-compliance with study procedures, adverse events that compromise participant safety, or withdrawal of consent. The study will adhere to rigorous ethical standards, ensuring that informed consent is obtained from all participants or their legal guardians prior to enrollment. The trial's primary endpoints focus on the safety and systemic exposure of the study drug, as well as its potential impact on the HPA axis, with no secondary endpoints specified.

Treatment

The clinical trial involves the use of **Bryhali**, a **cutaneous liquid** formulation containing the active substance **halobetasol propionate**. This experimental medication is administered via **topical administration**. The dosage regimen for Bryhali is a maximum daily dose of 7 grams, with a total maximum dose of 392 grams over the course of the treatment period. The treatment is applied once daily for a duration of 8 weeks. The formulation is not specifically designed for pediatric use, and the active substance is of chemical origin. The sponsor product code for this formulation is IDP-122 Lotion, and it is manufactured by Bausch Health Americas Inc.

In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are utilized. The focus is solely on evaluating the safety, systemic exposure, and hypothalamic-pituitary-adrenal (HPA) axis suppression potential of the IDP-122 Lotion when applied topically. Participant compliance with the dosing schedule is monitored throughout the study to ensure adherence to the prescribed regimen.

Efficacy

Efficacy in this clinical trial will be assessed through the evaluation of the **systemic exposure** of halobetasol propionate (HP) and the potential for **hypothalamic-pituitary-adrenal (HPA) axis suppression**. The primary endpoints include the safety of IDP-122 Lotion, administered topically once daily, and the systemic exposure of HP after topical application. Additionally, the potential for HPA axis suppression will be evaluated when the lotion is applied once daily for a period of 8 weeks. These assessments will be conducted in pediatric subjects with moderate to severe plaque psoriasis.

Inclusion and Exclusion Criteria

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Inclusion Criteria

Male or female, of any race, 6 to 16 years 11 months of age at the time of informed consent/assent obtained.
Verbal and written informed consent/assent obtained from the subject and/or parent or legal guardian
Has a clinical diagnosis of psoriasis at the Screening and Baseline visit with an Investigator’s Global Assessment (IGA) score of 3 or 4. The face, scalp, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present.
Has an area of plaque psoriasis appropriate for topical treatment that involves a BSA of at least 10% at Screening and Baseline. The face, scalp, axillae, and intertriginous areas are to be excluded in this calculation
Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study
Is in good general adrenal health, as determined by a 30-minute postcosyntropin stimulation serum cortisol level that is > 18 μg/dL at screening.
Is in good general health based on the subject’s medical history and a physical examination, with screening hematology and serum chemistry laboratory values within normal ranges or not clinically significant, as determined by the investigator
Pre-menses females (9 and older) and females of childbearing potential, must have a negative urine and serum pregnancy test at Screening and a negative urine pregnancy test at the Baseline visit prior to study drug application.
Females of childbearing potential and females who are pre-menses (9 and older) must be willing to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, IUD, condom with spermicidal, diaphragm with spermicidal, implant, Nuvaring, injection, transdermal patch or abstinence.). Females on birth control pills must have taken the same type pill for at least three months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least three months prior to the start of the study
Subject is willing to comply with study instructions and return to the clinic for required visits.

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Exclusion Criteria

Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator
Has a history of adrenal disease
Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator
Is pregnant, nursing an infant, or planning a pregnancy during the study period
Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to baseline, or is concurrently participating in another clinical study with an investigational drug or device.
Received treatment with a topical antipsoriatic drug product other than corticosteroids within 14 days prior to the Baseline visit, and/or treatment containing corticosteroids within 28 days prior to the screening HPA axis stimulation test.
Has used any phototherapy (including laser), photochemotherapy, or systemic non-biologic psoriasis therapy (such as newer oral psoriasis medications [eg, Otezla], methotrexate, retinoids or cyclosporine) within 4 weeks prior to the Baseline visit, or systemic corticosteroids within 28 days prior to the screening HPA axis stimulation test.
Has used immunomodulatory therapy (e.g., biologics) known to affect psoriasis within 3 months of baseline.
Has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 4 weeks prior to screening or is intending to have exposure during the study thought likely by the investigator to modify the subject’s psoriasis
Is currently using lithium or Plaquenil
Has a history of hypersensitivity or allergic reaction to any of the study drug constituents.
Is unable to be compliant with study procedures, study drug administration requirements, study visit schedules, and prohibitions regarding the use of concomitant medications/therapies
Is unable to communicate or cooperate with the investigator.
Has any underlying disease deemed uncontrolled by the investigator that poses a concern for the subject’s safety while participating in the study.
Has a history of drug or alcohol abuse as determined by the investigator.
Is considered by the investigator, for any other reason, to be an unsuitable candidate for the study.
Has an abnormal sleep schedule or works at night.
Has a history of an adverse reaction to cosyntropin injection or similar test reagents