Efficacy and Safety Study of QAW039 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis.

NCT01785602 | Completed Phase 2 Results

• 2 other identifiers: CQAW039X22012012-005321-78
• Study Type: interventional
• Target: 103
• Locations: 7 countries
• Sites: 17

Brief Summary

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).

Conditions

Atopic Dermatitis

Keywords

Atopic eczema; Skin Diseases

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Eczema Area and Severity Index (EASI)

  Investigators assessed presence and severity of erythema, induration/papulation, excoriation, and lichenification in four body areas: head/neck (H), upper limbs (UL), trunk (T), and lower limbs (LL). Investigators assigned a severity score from 0 - 3 for each area (none=0, mild=1, moderate=2, and severe=3). Investigators could assign half-points. Investigators also assigned an area score from 0 (no atopic dermatitis lesion in the area) to 6 (entire area is affected) for each area. The weighting factor was 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The total body score for each body region was obtained by multiplying the sum of the severity scores of the four key signs by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gave the EASI total, ranging from 0 to 72. A higher score represented greater disease severity. A negative change from baseline indicates improvement.

  Baseline, 12 weeks

Secondary Outcomes (1)

• Change From Baseline in Eczema Area and Severity Index

  Baseline, 4 weeks, 8 weeks

Study Arms (2)

QAW039

EXPERIMENTAL

Participants received QAW039 450 mg daily by mouth.

Drug: QAW039

Placebo

PLACEBO COMPARATOR

Participants received matching placebo to QAW039.

Drug: Placebo

Interventions

QAW039 DRUG

Capsules

QAW039

Placebo DRUG

Capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of hypersensitivity to any of the study drugs (including local anesthesia) or to drugs of similar chemical classes (CRTh2 antagonists)
• History of serious allergic reactions to any allergen, such as anaphylactic shock or life-threatening asthma, prior intubation, respiratory arrest, hospitalization due to asthma within the last 3 months or seizures as a result of asthma
• History of clinically significant ECG abnormalities or screening/baseline ECG that demonstrated clinical significant abnormalities which could affect patient safety or interpretation of study results
• History of long QT syndrome or whose QTc interval (Frederica's) was prolonged (\>450 msec for males and females) at screening
• Use of topical prescription treatment (e.g., topical corticosteroids, calcineurin inhibitors, antibiotics, etc.) within two weeks prior to initial dosing of study drug. Patient use of emollients was encouraged
• Exception: For local atopic dermatitis flares during this 2-week interval, mild topical corticosteroids may be taken short term (up to one week)
• Recent previous systemic treatment with phototherapy, systemic antihistamines, immunosuppressive agents (e.g., cyclosporine, mycophenolate, or oral tacrolimus, including therapeutic proteins)
• Patients on maintenance immunotherapy who either began their allergen specific immunotherapy regimen or had a clinically relevant change to their immunotherapy within one month prior to granting informed consent
• Patients on high-dose statin therapy (\>40 mg fluvastatin or 20 mg simvastatin, atorvastin, pravastatin, or rosuvastatin \[10 mg if Asian\])
• Excessive exposure to UV light in the three weeks prior to study start (screening), including tanning and sun beds and/or planning excessive sunbathing or beach holidays with associated sun bathing during the treatment period
• History of hypertrophic scarring
• Body mass index \<17 or \>40 kg/m2

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (18)

Novartis Investigative Site

Phillip, Australian Capital Territory, 2606, Australia

Location

Novartis Investigative Site

Benowa, Queensland, 4217, Australia

Location

Novartis Investigative Site

Woolloongabba, Queensland, 4102, Australia

Location

Novartis Investigative Site

Vienna, Austria

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Liège, 4000, Belgium

Location

Novartis Investigative Site

Sofia, Bulgaria, 1612, Bulgaria

Location

Novartis Investigative Site

Dresden, Germany, 01307, Germany

Location

Novartis Investigative Site

Berlin, 10098, Germany

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Bonn, 53105, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

Novartis Investigative Site

Amsterdam, 1105 AZ, Netherlands

Location

Novartis Investigative Site

Groningen, Netherlands

Location

Novartis Investigative Site

Utrecht, 3508 GA, Netherlands

Location

Novartis Investigative Site

Bucharest, 011461, Romania

Location

Novartis Investigative Site

Durban, 4001, South Africa

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Skin Diseases

Interventions

fevipiprant

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 7, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 15, 2015
• Results First Posted: December 15, 2015

Record last verified: 2015-11

Locations

BU (1); ZA (1); DE (5); AU (3); BE (3); NL (3); RO (1)