Safety and Efficacy of LEO 80185 Topical Suspension in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis

LEO Pharma31 enrolled

Overview

The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO 80185 topical suspension in adolescent subjects (aged 12 to 17 years) with scalp psoriasis. LEO 80185 topical suspension has marketing approval in many countries under the brand names Taclonex Scalp® Topical Suspension and Xamiol® gel for the treatment of scalp psoriasis in adults. No studies have been performed in subjects younger than 18 years.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Scalp Psoriasis

Interventions

LEO 80185 (Taclonex® Scalp topical suspension/Xamiol® gel)DRUG

Topical suspension applied once daily for up to 8 weeks

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent given by parent(s) or legal guardian following their receipt of verbal and written information about the study * Subjects will receive verbal and written information and will provide written assent to the study * Any race or ethnicity * Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs * At Screening Visit 2 and Visit 1 a clinical diagnosis of scalp psoriasis which is: * amenable to topical treatment with a maximum of 60 g of study medication per week, and * of an extent of more than or equal to 20% of the scalp area * of at least moderate severity according to the investigator's global assessment * Subjects with a normal HPA axis function at SV2 including serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge * A serum albumin-corrected calcium below the upper reference limit at Screening Visit 2 * Females of child-bearing potential must have a negative urine pregnancy test result and must agree to use a highly effective method of contraception (abstinence is an acceptable method). Exclusion Criteria (summary): * A history of serious allergy, allergic asthma or serious allergic skin rash * Known or suspected hypersensitivity to any medication (including ACTH/cosyntropin/tetracosactide) or to any component of the LEO 80185 topical suspension or CORTROSYN * Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to Screening Visit 2 or during the study * Topical treatment with corticosteroids within 2 weeks prior to Screening Visit 2 or during the study * Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to Screening Visit 2 or during the study * Enzymatic inductors (e.g., barbiturates, phenytoin, rifampicin)or cytochrome P450 inhibitors (e.g., ketoconazole, itraconazole, metronidazole) within 4 weeks prior to Screening Visit 2 or during the study. Topical ketoconazole 2 weeks prior to Screening Visit 2 * Hypoglycemic sulfonamides or Antidepressive medications within 4 weeks prior to Screening Visit 2 or during the study * Known or suspected endocrine disorder that may affect the results of the ACTH challenge test * Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis within the following time period prior to Visit 1 and during the study within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1 * Systemic treatment with therapies other than biologicals, with a possible effect on scalp psoriasis (e.g., retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the study * Planned initiation of, or changes to, concomitant medication that could affect scalp psoriasis (e.g., betablockers, chloroquine, lithium, ACE inhibitors) during the study * Other inflammatory skin diseases that may confound the evaluation of scalp psoriasis * Known or suspected disorders of calcium metabolism associated with hypercalcaemia

Locations (6)

Rady Children's Hospital San Diego

San Diego, California, United States

Leavitt Medical Associates of Florida, Inc.

Jacksonville, Florida, United States

Leavitt Medical Associates of Florida, Inc.

Ormond Beach, Florida, United States

Peachtree Dermatology Associates, PC

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Percentage of Subjects With Adverse Drug Reactions (ADRs)

Adverse events for which the investigator did not describe the causal relationship to IP as not related

Time frame: Throughout trial, up to 8 weeks

Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4

Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.

Time frame: Week 4

Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8

Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.

Time frame: week 8

Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTHchallenge at Week 4.

Time frame: week 4

Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Week 8.

Time frame: week 8

Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.

Data from ClinicalTrials.gov

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Secondary Outcomes

Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8

Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8

Time frame: Baseline and week 4

Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8

Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8

Time frame: Baseline and week 8

Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.

Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation. The IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.

Time frame: week 2

Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.

Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.

Time frame: week 4

Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.

Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.

Time frame: week 8

Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.

Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.

Time frame: End of treatment

Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.

Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score(ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).

Time frame: week 2

Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.

Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).

Time frame: Baseline and week 4

Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.

Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).

Time frame: Baseline and week 8

Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign,Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.

Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).

Time frame: Baseline and end of treatment (up to 8 weeks)

Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.

Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale scores are based on the following; 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe.

Time frame: week 2

Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.

Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.

Time frame: week 4

Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.

Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.

Time frame: week 8

Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.

Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.

Time frame: End of treatment