A Study Evaluating the Safety and Efficacy of QGE031 in Atopic Dermatitis Patients

Novartis

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Cyclosporine A; Drug: QGE031; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01552629

CQGE031X2201

2011-002112-84 (EudraCT Number)

Details and patient eligibility

About

The study will assess the safety and efficacy of QGE031 in the treatment of moderate to severe atopic dermatitis patients. In addition, QGE031 levels in the blood will be measured and the effect of QGE031 on markers in the blood and skin will be evaluated. Comparisons of the effect of QGE31 will be made with placebo and also cyclosporine, a treatment already established as being effective in atopic dermatitis.

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion criteria:

• Male and female patients 18 to 65 years of age inclusive (at the time of the screening visit), and who passed screening examinations by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.

• Presence of atopic dermatitis confirmed by itchy skin condition in the past 12 months (must have), plus three, or more, of the following:

  1. History of involvement of the skin creases (fronts of elbows, behind knees, fronts of ankles, around neck or around eyes)
  2. Personal history of asthma or hay fever
  3. History of generally dry skin in the past year
  4. Onset before age of 2 years
  5. Visible flexural dermatitis

• Patients with an EASI score of ≥20 at screening and stable AD (not currently experiencing an acute flare of their AD or had a significant change in the extent of their disease or their treatment regimen in the month prior to enrollment)

• Patients with a Total IgE in the range of 30 to 5000 IU/mL inclusive

Key exclusion criteria:

• Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test

• Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners had been sterilized by vasectomy or other means unless they were using a highly effective method of birth control:

• Total abstinence

• Male/female sterilization

• Combination of any two of the following (a+b or a+c or b+c):

  1. Use of oral, injected or implanted hormonal methods of contraception
  2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
  3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 3 patient groups, including a placebo group

Group 1 QGE031

Experimental group

Description:

QGE031 will be administered as a subcutaneous dose q2 weeks

Treatment:

Drug: QGE031

Group 2 Placebo

Placebo Comparator group

Description:

A QGE031 matched placebo will be administered as a subcutaneous dose q2 weeks

Treatment:

Drug: Placebo

Group 3 Cyclosporine A

Experimental group

Description:

Cyclosporine A will be administered (as per label) for atopic dermatitis.

Treatment:

Drug: Cyclosporine A