Moderate to Severe Plaque Psoriasis
Conditions
Interventions
Product Name: BRYHALI
Product Code: IDP-122 Lotion
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: IDP-122
Current Sponsor code: IDP-122
Other descriptive name: HALOBETASOL PROPIONATE
Con
Sponsors
Bausch Health Americas, Inc.(affiliate of Bausch Health US ,formerly known as Dow Pharmaceutical Sciences)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, 6 to 16 years 11 months of age at the time of informed consent/assent obtained. 2. Verbal and written informed consent/assent obtained from the subject and/or parent or legal guardian. 3. 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. 4. 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. 5. Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation for the duration of the study. 6. Is in good general adrenal health, as determined by a 30-minute postcosyntropin stimulation test. 7. 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. 8. 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. 9. 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. 10. Subject is willing to comply with study instructions and return to the clinic for required visits. Are the trial subjects under 18? yes Number of subjects for this age range: 45 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Has spontaneously improving or rapidly deteriorating Plaque psoriasis or pustular psoriasis, as determined by the investigator. 2. Has a history of adrenal disease. 3. Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator. 4. Is pregnant, nursing an infant, or planning a pregnancy during the study period. 5. 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. 6. 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. 7. 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 8. Has used immunomodulatory therapy (e.g., biologics) known to affect psoriasis within 3 months of baseline 9. 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. 10. Is currently using lithium or Plaquenil. 11. Has a history of hypersensitivity or allergic reaction to any of the study drug constituents 12. Is unable to be compliant with study procedures, study drug administration requirements, study visit schedules, and prohibitions regarding the use of concomitant medications/therapies. 13. Is unable to communicate or cooperate with the investigator. 14. Has any underlying disease deemed uncontrolled by the investigator that poses a concern for the subject's safety while participating in the study. 15. Has a history of drug or alcohol abuse as determined by the Investigator. 16. Is considered by the investigator, for any other reason, to be an unsuitable candidate for the study. 17. Has an abnormal sleep schedule or works at night. 18. Has a history of an adverse reaction to cosyntropin injection or similar test reagents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the following in pediatric subjects (6-16 years 11 months of age) with moderate to severe plaque psoriasis: • Safety of IDP-122 (HP 0.01%) Lotion administered topically once daily for 8 weeks • Systemic exposure of HP from IDP-122 Lotion when applied once daily for 4 weeks • HPA axis suppression potential for IDP-122 Lotion when applied once daily for 8 weeks;Secondary Objective: Not applicable;Primary end point(s): 1 Safety of IDP-122 (HP 0.01%) Lotion administered topically once daily 2 Systemic exposure of HP after topical application of IDP-122 Lotion once daily 3 Hypothalamic-pituitary-adrenal (HPA) axis suppression potential for IDP-122 Lotion when applied once daily;Timepoint(s) of evaluation of this end point: 1- After 8 weeks of treatment 2- After 4 weeks of treatment 3- After 8 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Panama, Poland, United States
Contacts
Public ContactLegal Representative
Dr. Gerhard Mann chem.-pharm. Fabrik GmbH
Outcome results
None listed