A research Study to evaluate the efficacy and safety of LEO 90100 aerosol foam for adolescent patients with plague psoriasis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

•Adolescent subjects (age 12 to 16 years, 11 months).
•Plaque psoriasis on trunk and/or limbs affecting at least 2% BSA.
•Plaque psoriasis on the scalp affecting at least 10% of total scalp area.
•A total psoriatic involvement on trunk, limbs and scalp not exceeding 30% BSA.
•PGA score of at least mild on trunk and/or limbs at SV1, SV2 and V1.
•PGA score of at least mild on scalp at SV1, SV2 and V1.
•A serum albumin-corrected calcium below the upper reference limit at SV2.
•Female subjects must be of either
•non-childbearing potential, i.e. premenarchal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal litigation) or,
•child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.
•Female subjects of child-bearing potential must be willing to use highly effective contraception at trial entry and until completion.

30 evaluable subjects without adrenal suppression at baseline will undergo an ACTH-challenge test (Visit 3) and PK assessments (Visit 2 and Visit 3).
The ACTH-challenge test as well as PK assessments will only be performed at assigned sites and countries.

Are the trial subjects under 18? yes
Number of subjects for this age range: 100
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

•A history of hypersensitivity to any component of LEO 90100.
•Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp and/or body psoriasis within the following time period prior to V1 and during the trial:
a.etanercept – within 4 weeks prior to V1
b.adalimumab, infliximab – within 2 months prior to V1
c.ustekinumab – within 4 months prior to V1
d.experimental products – within 4 weeks/5 half-lives (whichever is longer) prior to V1
•Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g. methotrexate, retinoids, immunosuppressants) within 4 weeks prior to V1 or during the trial.
•PUVA therapy within 4 weeks prior to V1.
•UVB therapy within 2 weeks prior to V1 or during the trial.
•Any topical treatment on the scalp and body including corticosteroids and vitamin D (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to V1 or during the trial.
•Systemic calcium, vitamin D supplementation > 400 IU/day, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to SV2 or during the trial. (note: stable dose of vitamin D supplementation = 400 IU/day is permitted provided there are no dose adjustments during the study period).
Additional exclusion criteria for subjects undergoing HPA axis testing:
A history of serious allergy, allergic asthma or serious allergic skin rash.
Known or suspected hypersensitivity to any component of CORTROSYN® (including ACTH/cosyntropin/tetracosactide)
Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2 or during the trial.
Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to SV2 or during the trial.
Enzymatic inductors (e.g., barbiturates, phenytoin, rifampicin) within 4 weeks prior to SV2 or during the trial.
Systemic or topical cytochrome P450 inhibitors (e.g., ketoconazole, itraconazole,metronidazole) within 4 weeks prior to SV2 or during the trial. Topical ketoconazole within 2 weeks prior to SV2.
Hypoglycemic sulfonamides within 4 weeks prior to SV2 or during the trial.
Antidepressive medications within 4 weeks prior to SV2 or during the trial.
Known or suspected endocrine disorder that may affect the results of the ACTH challenge test.
Clinical signs or symptoms of Cushing’s disease or Addison’s disease.
Subjects with diabetes mellitus.
Known or suspected cardiac condition.
Not following nocturnal sleep patterns.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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