NCT01552629

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2012

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2013

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

January 26, 2012

Last Update Submit

February 20, 2017

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitisAtopic eczemaSkin DiseasesQGE031

Outcome Measures

Primary Outcomes (1)

  • Change in Eczema Area and Severity Index(EASI)

    Efficacy response will be assessed using EASI.

    baseline, 12 weeks

Secondary Outcomes (3)

  • Change in Investigator Global Assessment (IGA) for atopic dermatitis

    6 weeks, 12 weeks

  • Number of participants with adverse events

    24 weeks

  • QGE031 plasma concentrations

    24 weeks

Study Arms (3)

Group 1 QGE031

EXPERIMENTAL

QGE031 will be administered as a subcutaneous dose q2 weeks

Drug: QGE031

Group 2 Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Group 3 Cyclosporine A

EXPERIMENTAL

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

Drug: Cyclosporine A

Interventions

QGE031DRUG
Group 1 QGE031
PlaceboDRUG
Group 2 Placebo
Cyclosporine ADRUG
Group 3 Cyclosporine A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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 ≥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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigative Site

Vienna, Austria

Location

Novartis Investigative Site

Nice, 06202, France

Location

Novartis Investigative Site

Kiel, Germany, 24105, Germany

Location

Novartis Investigative Site

Bonn, 53105, Germany

Location

Related Links

MeSH Terms

Conditions

Dermatitis, AtopicSkin Diseases

Interventions

ligelizumabCyclosporine

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

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

January 26, 2012

First Posted

March 13, 2012

Study Start

January 5, 2012

Primary Completion

August 28, 2013

Study Completion

August 28, 2013

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

DE(2)AU(1)FR(1)