Atopic DermatitisPhase 2NCT01552629
A Study Evaluating the Safety and Efficacy of QGE031 in Atopic Dermatitis Patients
A Phase 2 study testing QGE031 and Cyclosporine A in people with Atopic Dermatitis, run by Novartis Pharmaceuticals at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- QGE031 and Cyclosporine A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 5 Jan 2012to 28 Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
Novartis Investigative Site
Bonn, 53105
Novartis Investigative Site
Kiel, Germany, 24105
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Parallel Group, Proof of Concept Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of QGE031 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis
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.
- Conditions
- Atopic Dermatitis
- Being tested
- QGE031, Placebo, Cyclosporine A
- Keywords
- Atopic dermatitis, Atopic eczema, Skin Diseases, QGE031
- Medical subject headings
- Dermatitis, Atopic, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QGE031Drug
PlaceboDrug
Cyclosporine ADrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 QGE031 | Experimental | QGE031 will be administered as a subcutaneous dose q2 weeks Receives: Drug: QGE031 |
| Group 2 Placebo | Placebo comparator | A QGE031 matched placebo will be administered as a subcutaneous dose q2 weeks Receives: Drug: Placebo |
| Group 3 Cyclosporine A | Experimental | Cyclosporine A will be administered (as per label) for atopic dermatitis. Receives: Drug: Cyclosporine A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Eczema Area and Severity Index(EASI)
Efficacy response will be assessed using EASI.
Measured: baseline, 12 weeks
Secondary outcomes (3)
Change in Investigator Global Assessment (IGA) for atopic dermatitis
Participants dermatitis will be visually assessed and an IGA score will be determined by the Investigator using a prespecified evaluation criteria.
Measured: 6 weeks, 12 weeks
Number of participants with adverse events
Adverse events will be determined by observation and non-leading questioning of patients, and by measuring safety parameters (electrocardiograms, clinical laboratory, blood pressure)
Measured: 24 weeks
QGE031 plasma concentrations
Blood samples will be collected on Day 1(predose),15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155, and 169 for determination of QGE031 serum levels
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study start5 Jan 2012
- Primary completion28 Aug 2013
- Study completion28 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552629
- Sponsor's protocol ID
- CQGE031X2201
- Other IDs
- 2011-002112-84
- Status last verified
- Feb 2017
- First submitted
- 26 Jan 2012
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Parallel Group, Proof of Concept Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of QGE031 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01552629
- Acronym / sponsor ID
- CQGE031X2201
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Atopic eczema, Skin Diseases, QGE031
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2012 (actual)
- Primary completion
- 28 Aug 2013 (actual)
- Study completion
- 28 Aug 2013 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 QGE031 | Experimental | Drug: QGE031QGE031 will be administered as a subcutaneous dose q2 weeks |
| Group 2 Placebo | Placebo comparator | Drug: PlaceboA QGE031 matched placebo will be administered as a subcutaneous dose q2 weeks |
| Group 3 Cyclosporine A | Experimental | Drug: Cyclosporine ACyclosporine A will be administered (as per label) for atopic dermatitis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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 (8 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QGE031 | Drug | Group 1 QGE031 |
| Placebo | Drug | Group 2 Placebo |
| Cyclosporine A | Drug | Group 3 Cyclosporine A |
Primary outcome
Change in Eczema Area and Severity Index(EASI)
Time frame: baseline, 12 weeks
Efficacy response will be assessed using EASI.
3 secondary outcomes
Change in Investigator Global Assessment (IGA) for atopic dermatitis
Time frame: 6 weeks, 12 weeks
Number of participants with adverse events
Time frame: 24 weeks
QGE031 plasma concentrations
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QGE031 and Cyclosporine A in people with Atopic Dermatitis, run by Novartis Pharmaceuticals at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Austria, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Eczema Area and Severity Index(EASI) (time frame: baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.