Eosinophilic EsophagitisPhase 2NCT01022970
Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis
A Phase 2 study testing QAX576 in people with Eosinophilic Esophagitis, run by Novartis Pharmaceuticals at 5 sites in United States.
Trial summary
This study is designed to investigate the effects of a 12 week course of intravenous QAX576 6mg/kg every 4 weeks in reducing the number of eosinophils in the esophagus of EoE patients by 75% or greater when compared with baseline. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- QAX576
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2009to Feb 2012
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females aged 18-50 with symptomatic eosinophilic esophagitis
- Female subjects must be women of non child bearing potential.
- Elimination diet must have been tried.
- Treatment for at least two months prior to enrollment on a protocol pump inhibitor .
- Appropriate contraception must be used by males, (e.g., spermicidal gel plus condom)
- Must be able to communicate well with the investigator, to understand and comply with the requirements of the study.
- Understand and sign the written informed consent.
Who cannot join
- Have received corticosteroids within 3 months before starting the study for any symptoms.
- Any other eosinophilic disorders.
- History of clinical schistosomiasis, or having travelled within the preceding 6 months to an area with endemic schistosomiasis, including but not limited to Southeast and Southwest Asia, South America and Africa. Travel to these areas must not be planned for at least 6 months after the last dose.
- Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing.
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Mayo Clinic
Minneota, Minnesota, 55905
Oral Alpan, 6210 Old Keene Mill Court,
Springfield, Virginia, 22152
Stanford Medical Center and Lucile Packard Children's Hospital
Stanford, California, 94305
About this study
Official title: A Double Blinded Randomized Placebo-controlled Trial of Intravenous QAX576 in the Treatment of Eosinophilic Esophagitis (EoE)
This study is designed to investigate the effects of a 12 week course of intravenous QAX576 6mg/kg every 4 weeks in reducing the number of eosinophils in the esophagus of EoE patients by 75% or greater when compared with baseline.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- QAX576 placebo, QAX576
- Keywords
- Esophagitis, Digestive System Diseases, Esophageal disorder, Eosinophilic esophagitis
- Medical subject headings
- Eosinophilic Esophagitis, Esophagitis, Digestive System Diseases, Esophageal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAX576 placeboDrug
QAX576Drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: QAX576 placebo |
| QAX576 | Active comparator | Not described Receives: Drug: QAX576 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint in this study is the number of patients (responder) with a reduction of 75% or more in eosinophils per HPF (distal or proximal esophagus) from baseline to week 13.
Measured: 13 weeks
Secondary outcomes (4)
To ascertain the effect of QAX576 in the frequency and severity of the symptoms of EoE.
Measured: 34 weeks
To investigate the safety and tolerability of QAX576 in patients with EoE.
Measured: 34 weeks
To establish the duration of clinical benefit after a 12 week course of therapy.
Measured: 34 weeks
PK/PD relationship between blood levels of QAX576 and IL- 13 dependent gene expression in esophageal biopsies and soluble biomarkers, inflammatory and fibrotic markers within esophageal biopsies and activation markers expressed on peripheral
Measured: 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022970
- Sponsor's protocol ID
- CQAX576A2205
- Status last verified
- Mar 2021
- First submitted
- 25 Nov 2009
- Last updated
- 11 Mar 2021
- Results posted
- No
Publications
Rothenberg ME, Wen T, Greenberg A, Alpan O, Enav B, Hirano I, Nadeau K, Kaiser S, Peters T, Perez A, Jones I, Arm JP, Strieter RM, Sabo R, Gunawardena KA. Intravenous anti-IL-13 mAb QAX576 for the treatment of eosinophilic esophagitis. J Allergy Clin Immunol. 2015 Feb;135(2):500-7. doi: 10.1016/j.jaci.2014.07.049. Epub 2014 Sep 13.
PubMed 25226850
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blinded Randomized Placebo-controlled Trial of Intravenous QAX576 in the Treatment of Eosinophilic Esophagitis (EoE)
- ClinicalTrials.gov ID
- NCT01022970
- Acronym / sponsor ID
- CQAX576A2205
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Esophagitis, Digestive System Diseases, Esophageal disorder, Eosinophilic esophagitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Feb 2012 (actual)
- First posted
- 1 Dec 2009 (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.
This study is designed to investigate the effects of a 12 week course of intravenous QAX576 6mg/kg every 4 weeks in reducing the number of eosinophils in the esophagus of EoE patients by 75% or greater when compared with baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: QAX576 placebo |
| QAX576 | Active comparator | Drug: QAX576 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males and females aged 18-50 with symptomatic eosinophilic esophagitis
- Female subjects must be women of non child bearing potential.
- Elimination diet must have been tried.
- Treatment for at least two months prior to enrollment on a protocol pump inhibitor .
- Appropriate contraception must be used by males, (e.g., spermicidal gel plus condom)
Key exclusion criteria (7 listed)
- Have received corticosteroids within 3 months before starting the study for any symptoms.
- Any other eosinophilic disorders.
- History of clinical schistosomiasis, or having travelled within the preceding 6 months to an area with endemic schistosomiasis, including but not limited to Southeast and Southwest Asia, South America and Africa. Travel to these areas must not be planned for at least 6 months after the last dose.
- Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing.
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
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 |
|---|---|---|
| QAX576 placebo | Drug | Placebo |
| QAX576 | Drug | QAX576 |
Primary outcome
The primary endpoint in this study is the number of patients (responder) with a reduction of 75% or more in eosinophils per HPF (distal or proximal esophagus) from baseline to week 13.
Time frame: 13 weeks
4 secondary outcomes
To ascertain the effect of QAX576 in the frequency and severity of the symptoms of EoE.
Time frame: 34 weeks
To investigate the safety and tolerability of QAX576 in patients with EoE.
Time frame: 34 weeks
To establish the duration of clinical benefit after a 12 week course of therapy.
Time frame: 34 weeks
PK/PD relationship between blood levels of QAX576 and IL- 13 dependent gene expression in esophageal biopsies and soluble biomarkers, inflammatory and fibrotic markers within esophageal biopsies and activation markers expressed on peripheral
Time frame: 34 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 11 Mar 2021.
- Derived from this study: PubMed 25226850Rothenberg ME, Wen T, Greenberg A, Alpan O, Enav B, Hirano I, Nadeau K, Kaiser S, Peters T, Perez A, Jones I, Arm JP, Strieter RM, Sabo R, Gunawardena KA. Intravenous anti-IL-13 mAb QAX576 for the treatment of eosinophilic esophagitis. J Allergy Clin Immunol. 2015 Feb;135(2):500-7. doi: 10.1016/j.jaci.2014.07.049. Epub 2014 Sep 13.
- Results for CQAX576A2205 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QAX576 in people with Eosinophilic Esophagitis, run by Novartis Pharmaceuticals at 5 sites in United States.
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 7 inclusion and 7 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 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
The primary endpoint in this study is the number of patients (responder) with a reduction of 75% or more in eosinophils per HPF (distal or proximal esophagus) from baseline to week 13. (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01022970, which also lists 1 linked publication.
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 11 Mar 2021.