A Study Evaluating the Persistency of Response With or Without Xolair After Long-Term Therapy (XPORT)
This study is enrolling participants by invitation only.
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01125748
First received: May 14, 2010
Last updated: August 23, 2012
Last verified: August 2012
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Purpose
This is a randomized, double-blind, placebo-controlled, two-armed, one-year study of patients who have completed the EXCELS study (NCT00252135) and have been treated with Xolair long-term.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Asthma |
Drug: omalizumab Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase IV, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Persistency of Response With or Without Xolair After Long-Term Therapy |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Any protocol-defined severe exacerbation [ Time Frame: Throughout study (52 weeks) or until early discontinuation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to first protocol-defined severe exacerbation [ Time Frame: From initiation of study treatment to event (overall study is 52 weeks) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180180 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | November 2013 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: omalizumab
Administered subcutaneously according to dose and dosing interval in EXCELS study
|
| Placebo Comparator: B |
Drug: placebo
Administered subcutaneously according to dose and dosing interval in EXCELS study
|
Eligibility| Ages Eligible for Study: | 17 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- All EXCELS inclusion criteria and enrollment in the EXCELS study
- History of positive skin test or in vitro reactivity to an aeroallergen
- Continuous Xolair exposure from the beginning of EXCELS to randomization into this study. For the purposes of this study, continuous Xolair exposure is defined as having missed no more than 25% of scheduled Xolair doses. In addition, a maximum of 2 doses can be missed within the last 6 months before being randomized into this study
- Having completed EXCELS and not having discontinued Xolair since the completion of EXCELS
- Diagnosis of moderate to severe persistent allergic asthma while on Xolair
- Stable dosing of current asthma therapies, in addition to Xolair, over 2 months prior to enrollment
- Serum IgE level >= 30 to <= 700 IU/mL before initiation of Xolair treatment (prior to EXCELS enrollment or earlier)
- Body weight >= 30 to <= 150 kg
- Treatment with Xolair consistent with the USPI (based on the dosing table, recommended dose, administration, and dosing interval) at the time of completion of EXCELS study and prior to enrollment to this study
Exclusion Criteria:
- Participation in other therapy trials or planned participation during the following year from screening
- Contraindication to Xolair therapy
- Acute asthma exacerbation within the 2 months immediately prior to screening
- Any significant, or unstable, systemic disease, or a recent hospitalization because of systemic disease within the previous 2 months
- Diagnosis of active lung disease other than asthma
- Having more than 10 pack-years smoking history
- Diagnosis of cystic fibrosis
- Use of an experimental drug within 30 days prior to study screening
- Have elevated serum IgE levels for reasons other than allergy
- Pregnancy, lactation or any planned pregnancy in the following year
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125748
Show 101 Study Locations
Show 101 Study LocationsSponsors and Collaborators
Genentech
Investigators
| Study Director: | Clinical Trials | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01125748 History of Changes |
| Other Study ID Numbers: | Q4777n, ML01347 |
| Study First Received: | May 14, 2010 |
| Last Updated: | August 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity |
Immune System Diseases Omalizumab Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 22, 2013