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A Safety and Pharmacokinetics Study of IDP-118 Lotion in Pediatric Participants With Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
IDP-118 Lotion
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Plaque psoriasis

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is 4 to 16 years 11 months of age at time of informed consent/assent obtained.
  • Verbal and written informed consent/assent obtained from the participant and/or parent or legal guardian.
  • Has a clinical diagnosis of psoriasis at Screening and Baseline 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 the Screening visit.
  • Females of childbearing potential and females who are pre-menses (9 years and older) must be willing to practice effective contraception for the duration of the study.

Exclusion Criteria:

  • 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 a history of hypersensitivity or allergic reaction to any of the study drug constituents.
  • Is considered by the Investigator, for any other reason, to be an unsuitable candidate for the study.

Sites / Locations

  • Bausch Site 7Recruiting
  • Bausch Site 8Recruiting
  • Bausch Site 3Recruiting
  • Bausch Site 6Recruiting
  • Bausch Site 1
  • Bausch Site 11Recruiting
  • Bausch Site 5
  • Bausch Site 4Recruiting
  • Bausch Site 2Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IDP-118 Lotion

Arm Description

Two cohorts of pediatric participants (1 cohort of participants age 12 to 16 years 11 months and 1 cohort of participants age 4 to 11 years 11 months) will apply IDP-118 Lotion to Investigator identified lesions affecting a minimum of 10% body surface area (BSA) once daily for 8 weeks.

Outcomes

Primary Outcome Measures

Pharmacokinetics: : Maximum Observed Drug (Halobetasol Propionate, Tazarotene, or Tazarotenic Acid) Concentration in Plasma (Cmax) of IDP-118 Lotion Analytes
On Days 28-29, blood samples will be collected from each participant for the determination of plasma concentrations and PK parameters of IDP-118 lotion analytes.

Secondary Outcome Measures

Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression at Week 8
An HPA axis suppression is defined as a 30 minute poststimulation cortisol level of ≤18 micrograms/deciliter (μg/dL) at the end of the study.

Full Information

First Posted
June 13, 2019
Last Updated
July 25, 2023
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03988439
Brief Title
A Safety and Pharmacokinetics Study of IDP-118 Lotion in Pediatric Participants With Plaque Psoriasis
Official Title
A Phase 4, Open-Label, Multicenter Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion in Pediatric Subjects With Moderate to Severe Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is to evaluate the safety, the systemic exposure, and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-118 lotion in pediatric participants with moderate to severe plaque psoriasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Plaque psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IDP-118 Lotion
Arm Type
Experimental
Arm Description
Two cohorts of pediatric participants (1 cohort of participants age 12 to 16 years 11 months and 1 cohort of participants age 4 to 11 years 11 months) will apply IDP-118 Lotion to Investigator identified lesions affecting a minimum of 10% body surface area (BSA) once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
IDP-118 Lotion
Intervention Description
Topical
Primary Outcome Measure Information:
Title
Pharmacokinetics: : Maximum Observed Drug (Halobetasol Propionate, Tazarotene, or Tazarotenic Acid) Concentration in Plasma (Cmax) of IDP-118 Lotion Analytes
Description
On Days 28-29, blood samples will be collected from each participant for the determination of plasma concentrations and PK parameters of IDP-118 lotion analytes.
Time Frame
0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose
Secondary Outcome Measure Information:
Title
Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression at Week 8
Description
An HPA axis suppression is defined as a 30 minute poststimulation cortisol level of ≤18 micrograms/deciliter (μg/dL) at the end of the study.
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is 4 to 16 years 11 months of age at time of informed consent/assent obtained. Verbal and written informed consent/assent obtained from the participant and/or parent or legal guardian. Has a clinical diagnosis of psoriasis at Screening and Baseline 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 the Screening visit. Females of childbearing potential and females who are pre-menses (9 years and older) must be willing to practice effective contraception for the duration of the study. Exclusion Criteria: 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 a history of hypersensitivity or allergic reaction to any of the study drug constituents. Is considered by the Investigator, for any other reason, to be an unsuitable candidate for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alison Magnotti-Nagel
Phone
19085418664
Email
alison.magnotti-nagel@bauschhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Varsha Bhatt
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Bausch Site 7
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 8
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 3
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 6
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 1
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Terminated
Facility Name
Bausch Site 11
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 5
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Individual Site Status
Terminated
Facility Name
Bausch Site 4
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 2
City
Panama City
Country
Panama
Individual Site Status
Recruiting

12. IPD Sharing Statement

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A Safety and Pharmacokinetics Study of IDP-118 Lotion in Pediatric Participants With Plaque Psoriasis

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