Efficacy and safety study of QAW039 in the treatment of patients with moderate to severe atopic dermatitis

• Register: EUCTR
• Last refreshed on: 23 November 2015
• Main ID: EUCTR2012-005321-78-DE
• Date of registration: 21/05/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Efficacy and safety study of QAW039 in the treatment of patients with moderate to severe atopic dermatitis
• Scientific title: A randomized, double-blind, placebo-controlled, parallel group study evaluating efficacy and safety of QAW039 in the treatment of patients with moderate to severe atopic dermatitis
• Date of first enrolment: 24/07/2013
• Target sample size: 92
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005321-78
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Germany, Netherlands, Romania, South Africa

Contacts

• Name: Medizinischer Infoservice (MCC)
• Affiliation: Novartis Pharma GmbH

• Name: Medizinischer Infoservice (MCC)
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
- Presence of atopic dermatitis confirmed by Itchy skin condition in the past 12 months plus three, or more, of the following:
• History of involvement of the skin creases (fronts of
elbows, behind knees, fronts of ankles, around neck or around eyes)
• Personal history of asthma or hay fever
• History of generally dry skin in the past year
• Onset before age of 2 years
• Visible flexural dermatitis

- Patients with an EASI score of =15 at screening and stable AD (not currently
experiencing an acute flare of their AD)

- Patients that have been treated with topical corticosteroids or topical calcineurin inhibitors on at least one occasion, or could not use topical drugs (due to
contraindications, side effects, etc.) and are candidates for or have previously received systemic treatment.
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 92
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
- Pregnant or nursing (lactating) women
- Women of child-bearing potential unless they are using a effective method of birth control (as further defined in study protocol)
- Recent previous systemic treatment with phototherapy, systemic antihistamines, immunosuppressive agents such as cyclosporine, mycophenolate, or oral tacrolimus, or therapeutic proteins.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Atopic dermatitis

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Intervention(s)

Product Code: QAW039, 150mg
Pharmaceutical Form: Capsule
INN or Proposed INN: QAW039
Other descriptive name: QAW039
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: ALK-prick SQ (SQ 106 139a/85a, SQ 108 141a/85a, SQ 113 142a/85a, SQ 225 148a/85a, SQ 231 150a/85a, SQ 299 151a/85a, SQ 312 152a/85a, SQ 360 405a/85a)
Pharmaceutical Form: Solution for skin-prick test
INN or Proposed INN: ALDER
Other descriptive name: ALDER POLLEN
Concentration unit: Other
Concentration type: equal
Concentration number: 10 HEP-
INN or Proposed INN: BIRCH
Other descriptive name: BIRCH
Concentration unit: Other
Concentration type: equal
Concentration number: 10 HEP-
INN or Proposed INN: HAZEL
Other descriptive name: HAZELNUT EXTRACT
Concentration unit: Other
Concentration type: equal
Concentration number: 10 HEP-
INN or Proposed INN: TIMOTHY
Other descriptive name: TIMOTHY GRASS POLLEN EXTRACT
Concentration unit: Other
Concentration type: equal
Concentration number: 10 HEP-
INN or Proposed INN: RYE
Other descriptive name: RYE
Concentration unit: Other
Concentration type: equal
Concentration number: 10 HEP-
INN or Proposed INN: GRASS MIXTURE
Other descriptive name: 13 GRASS POLLEN MIXTURE
Concentration unit: Other
Concentration type: equal
Concentration number: 10 HEP-
INN or Proposed INN: ARTEMISIA
Other descriptive name: ARTEMISIA
Concentration unit: Other
Concentration type: equal
Concentration number: 10 HEP-
INN or Proposed INN: PARIETARIA JUDAICA
Other descriptive name: PARIETARIA JUDAICA POLLEN EXTRACT
Concentration unit: Other
Concentration type: equal
Concentration number: 10 HEP-

Trade Name: ALK-prick N (N 115 158a/85a, N 117 159a/85a, N 132 164a/85a, N 134 165a/85a, N 138 167a/85a, N 302 187a/85a, N 317 191a/85a, N 322 192a/85a, N 342 196a/85a, N 351 202a/85a, N 356 205a/85a)
Pharmaceutical Form: Solution for skin-prick test
INN or Pro

Primary Outcome(s)

Main Objective: The purpose of this study is to determine whether QAW039 is safe and has beneficial effects in people who have moderate to severe atopic dermatitis (AD)

- Eczema Area and Severity Index (EASI) score in comparison to placebo
- Number of Participants with Adverse Events to assess Safety and tolerability

Secondary Objective:

Primary end point(s): - Change from baseline in Eczema Area and Severity Index (EASI) score to week 12 in comparison to placebo

- Number of Participants with Adverse Events used to assess Safety and tolerability after 12 weeks

Timepoint(s) of evaluation of this end point: week 12

Secondary Outcome(s)

Secondary end point(s): Change from baseline in Eczema Area and Severity Index score to 4 weeks and 8 weeks

Timepoint(s) of evaluation of this end point: week 4 and week 8

Secondary ID(s)

CQAW039X2201

2012-005321-78-AT

Source(s) of Monetary Support

Novartis Pharma Services AG