CBPR277X2101

• Conditions: Part 2: Atopic Dermatitis (AD)Part 3: Netherton Syndrome (NS); MedDRA version: 14.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; MedDRA version: 14.1Level: PTClassification code 10062909Term: Netherton's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-000917-38-NL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-09
• Last Update Posted: 10 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Subjects eligible for inclusion in this study have to fulfill all of the following criteria:

Part 1 (healthy volunteers)
• Healthy male and female subjects of non childbearing potential, 18 to 65 years of age inclusive and in good health

Part 2 (patients with atopic dermatitis):
• Male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
• Presence of atopic dermatitis confirmed by Itchy skin condition in the past 12 months (must have) Plus three or more of the following:
a. History of involvement of the skin creases
b. Personal history of asthma or hay fever
c. History of generally dry skin in the past year
d. Onset before age of 2 years
e. Visible flexural dermatitis
• Diagnosis of at least moderate atopic dermatitis by the IGA and a minimum target area (right or left) situated on the forearm including the antecubital fossa with a corresponding baseline total lesional sign score (TLSS)

Part 3 Cohort A, AA and AB (patients with Netherton Syndrome):
• Patients with Netherton syndrome, male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
• Confirmed diagnosis of Netherton syndrome (SPINK5 mutation or LEKTI deficiency in the skin).
• Minimum total lesional sign score NS (TLSS-NS) of 5-9 for two selected target areas at baseline. The TLSS-NS values need to be similar between the two areas at baseline.

Other protocol-defined inclusion/exclusion criteria may apply. Refer to protocol for details.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects fulfilling any of the following criteria are not eligible for inclusion in this study. Other protocol-defined exclusion criteria apply in addition to those listed hereafter:

Part 1 (healthy volunteers):
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
• Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing.

Part 2 (patients with atopic dermatitis):
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
• History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds.
• Pregnant or nursing (lactating) women.
• Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
• Use of topical prescription treatment for eczema within 1 week prior to initial dosing of topical corticosteroids (TCS).
• Recent previous treatment with systemic treatment including phototherapy. A washout period will be required for such patients to be eligible to participate in the trial.

Part 3 Cohorts A, AA & AB (patients with Netherton Syndrome):
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
• History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds.
• Pregnant or nursing (lactating) women.
• Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
• Use of topical prescription treatment within 2 week prior to initial dosing of study drug.
• Recent previous treatment with systemic treatment. A washout period will be required for such patients to be eligible to participate in the trial.

Other protocol-defined inclusion/exclusion criteria may apply. Refer to protocol for details.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified