Eosinophilic Esophagitis Clinical Trial
Official title:
A Double Blinded Randomized Placebo-controlled Trial of Intravenous QAX576 in the Treatment of Eosinophilic Esophagitis (EoE)
NCT number | NCT01022970 |
Other study ID # | CQAX576A2205 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | November 2009 |
Verified date | March 2021 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University Feinberg School of Medicine | Chicago | Illinois |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Mayo Clinic | Minnesota | Minnesota |
United States | Oral Alpan, 6210 Old Keene Mill Court, | Springfield | Virginia |
United States | Stanford Medical Center and Lucile Packard Children's Hospital | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 13 weeks | ||
Secondary | To ascertain the effect of QAX576 in the frequency and severity of the symptoms of EoE. | 34 weeks | ||
Secondary | To investigate the safety and tolerability of QAX576 in patients with EoE. | 34 weeks | ||
Secondary | To establish the duration of clinical benefit after a 12 week course of therapy. | 34 weeks | ||
Secondary | 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 | 34 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03382678 -
CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry
|
||
Completed |
NCT05083312 -
Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial
|
Phase 3 | |
Completed |
NCT04593251 -
Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis
|
Phase 1 | |
Completed |
NCT03633617 -
Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)
|
Phase 3 | |
Completed |
NCT04941742 -
The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)
|
||
Terminated |
NCT04543409 -
A Study of Benralizumab in Patients With Eosinophilic Esophagitis
|
Phase 3 | |
Terminated |
NCT02314455 -
Esophageal Absorption in EoE
|
N/A | |
Completed |
NCT01953575 -
Mucosal Impedance and Eosinophilic Esophagitis
|
N/A | |
Completed |
NCT01386112 -
Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis
|
Phase 1/Phase 2 | |
Recruiting |
NCT04991935 -
Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
|
Phase 3 | |
Not yet recruiting |
NCT05896891 -
San Raffaele EoE Biobank
|
||
Active, not recruiting |
NCT05482256 -
A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis
|
N/A | |
Recruiting |
NCT05485155 -
Zemaira Eosinophilic Esophagitis Pilot Study
|
Phase 2 | |
Recruiting |
NCT04149470 -
Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)
|
Phase 4 | |
Recruiting |
NCT04416217 -
Eosinophilic Esophagitis Steroid Safety Study
|
||
Completed |
NCT05084963 -
A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis
|
Phase 2 | |
Completed |
NCT02579876 -
Milk Patch for Eosinophilic Esophagitis
|
Phase 2 | |
Recruiting |
NCT02331849 -
Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry.
|
N/A | |
Active, not recruiting |
NCT02202590 -
Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus
|
N/A | |
Active, not recruiting |
NCT05176249 -
Prospective Database for Eosinophilic Esophagitis (EoE) of Pediatric Population
|