A Study of MEMP1972A in the Prevention of Allergen-Induced Airway Obstruction in Patients With Mild Asthma (SOLARIO)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MEMP1972A
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Mild, stable allergic asthma
- History of episodic wheeze and shortness of breath
- FEV1 at baseline >= 70% of the predicted value
- Males or females who are surgically sterilized, post menopausal for the past year, or are using two acceptable methods of contraception against pregnancy through at least 5 months following the last administration of study drug
- Documented PC20 value for prediction of the starting allergen concentration at screening
- Positive skin prick test to common standard aeroallergens extracts
- Positive allergen-induced early and late airway response
Exclusion Criteria:
- A worsening of asthma within 6 weeks preceding Visit 1
- Acute respiratory infection within 6 weeks preceding Visit 2 or any ongoing chronic infection
- History of recurrent bacterial infection as an adult or history or presence of any chronic infectious condition
- Risk of exposure, as determined by the investigator, to water-borne parasites or clinical diagnosis of parasitic infection that is untreated within 3 months prior to Visit 5
- Lung disease other than mild allergic asthma
- History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness
- History or symptoms of cardiovascular disease
- History or symptoms of significant neurologic disease
- History of significant hepatic or renal impairment
- Evidence of an active or suspected cancer or history of treatment for cancer
- History or symptoms of clinically significant autoimmune disease
- Any acquired or congenital immune deficiency
- Confirmed positive test for HIV or hepatitis B or C
- Concomitant disease or condition, which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, poses an unacceptable risk to the patients in this study
- History of serious adverse reaction or hypersensitivity to any drug
- Clinically significant abnormal chest radiograph within the last 12 months
- Pregnancy or lactation or positive serum pregnancy test at screening
- Use of corticosteroids, immunosuppressives, anticoagulants, or any medications that may interact with study drug within 4 weeks prior to Visit 2
- Chronic use of any other medication for treatment of allergic lung disease other than short-acting β2-agonists or ipratropium bromide
- Use of cromoglycate, nedocromil, leukotriene receptor antagonists, and inhibitors of 5-lipoxygenase are not permitted within 4 weeks prior to Visit 2
- Allergen or peptide immunotherapy within 6 months prior to study treatment
- Participation in any other investigational drug study within the preceding 30 days or 5 half-lives of that drug, whichever is longer at the time of Visit 2
- Current (or history of) treatment with a monoclonal antibody or chimeric biomolecule within the past 5 months, including omalizumab, at the time of Visit 2
- Use of statins are not permitted within 4 weeks prior to Visit 2
- Received live or attenuated vaccine within 30 days prior to Visit 5
- Regular use of tobacco products of any kind or within the previous 6 months, or smoking history > 10 pack-years
- History of drug or alcohol abuse
- Donation of blood over 500 mL within 3 months prior to Visit 5
- Unwillingness or inability to comply with the study protocol for any other reason
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Late airway response (LAR) area under the concentration-time curve (AUC) (percent decline in forced expiratory volume in 1 second [FEV1] over time)
Secondary Outcome Measures
Maximum percent decline in FEV1
Change in methacholine challenge PC20 relative to the pre-allergen challenge PC20
Maximum percent decline in FEV1 and early airway response (EAR) AUC (percent decline in FEV1 over time)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01196039
Brief Title
A Study of MEMP1972A in the Prevention of Allergen-Induced Airway Obstruction in Patients With Mild Asthma (SOLARIO)
Official Title
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous MEMP1972A in the Prevention of Allergen-Induced Airway Obstruction in Patients With Mild Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
Brief Summary
This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed to evaluate the efficacy, safety and tolerability of MEMP1972A when administered to patients by intravenous (IV) infusion for the treatment of allergen-induced asthma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MEMP1972A
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Intravenous repeating dose
Primary Outcome Measure Information:
Title
Late airway response (LAR) area under the concentration-time curve (AUC) (percent decline in forced expiratory volume in 1 second [FEV1] over time)
Time Frame
Between 3 and 7 hours after allergen challenge at Day 86 after the first dose
Secondary Outcome Measure Information:
Title
Maximum percent decline in FEV1
Time Frame
Immediately prior to the allergen challenge to between 3 and 7 hours after allergen challenge on Day 86 after the first dose
Title
Change in methacholine challenge PC20 relative to the pre-allergen challenge PC20
Time Frame
Day 87
Title
Maximum percent decline in FEV1 and early airway response (EAR) AUC (percent decline in FEV1 over time)
Time Frame
Between 0 and 3 hours after post-treatment allergen challenge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild, stable allergic asthma
History of episodic wheeze and shortness of breath
FEV1 at baseline >= 70% of the predicted value
Males or females who are surgically sterilized, post menopausal for the past year, or are using two acceptable methods of contraception against pregnancy through at least 5 months following the last administration of study drug
Documented PC20 value for prediction of the starting allergen concentration at screening
Positive skin prick test to common standard aeroallergens extracts
Positive allergen-induced early and late airway response
Exclusion Criteria:
A worsening of asthma within 6 weeks preceding Visit 1
Acute respiratory infection within 6 weeks preceding Visit 2 or any ongoing chronic infection
History of recurrent bacterial infection as an adult or history or presence of any chronic infectious condition
Risk of exposure, as determined by the investigator, to water-borne parasites or clinical diagnosis of parasitic infection that is untreated within 3 months prior to Visit 5
Lung disease other than mild allergic asthma
History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness
History or symptoms of cardiovascular disease
History or symptoms of significant neurologic disease
History of significant hepatic or renal impairment
Evidence of an active or suspected cancer or history of treatment for cancer
History or symptoms of clinically significant autoimmune disease
Any acquired or congenital immune deficiency
Confirmed positive test for HIV or hepatitis B or C
Concomitant disease or condition, which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, poses an unacceptable risk to the patients in this study
History of serious adverse reaction or hypersensitivity to any drug
Clinically significant abnormal chest radiograph within the last 12 months
Pregnancy or lactation or positive serum pregnancy test at screening
Use of corticosteroids, immunosuppressives, anticoagulants, or any medications that may interact with study drug within 4 weeks prior to Visit 2
Chronic use of any other medication for treatment of allergic lung disease other than short-acting β2-agonists or ipratropium bromide
Use of cromoglycate, nedocromil, leukotriene receptor antagonists, and inhibitors of 5-lipoxygenase are not permitted within 4 weeks prior to Visit 2
Allergen or peptide immunotherapy within 6 months prior to study treatment
Participation in any other investigational drug study within the preceding 30 days or 5 half-lives of that drug, whichever is longer at the time of Visit 2
Current (or history of) treatment with a monoclonal antibody or chimeric biomolecule within the past 5 months, including omalizumab, at the time of Visit 2
Use of statins are not permitted within 4 weeks prior to Visit 2
Received live or attenuated vaccine within 30 days prior to Visit 5
Regular use of tobacco products of any kind or within the previous 6 months, or smoking history > 10 pack-years
History of drug or alcohol abuse
Donation of blood over 500 mL within 3 months prior to Visit 5
Unwillingness or inability to comply with the study protocol for any other reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Harris, MD, Ph.D
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1Z1
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
City
Ste. Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
City
Stockholm
ZIP/Postal Code
S-14186
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
24990880
Citation
Gauvreau GM, Harris JM, Boulet LP, Scheerens H, Fitzgerald JM, Putnam WS, Cockcroft DW, Davis BE, Leigh R, Zheng Y, Dahlen B, Wang Y, Maciuca R, Mayers I, Liao XC, Wu LC, Matthews JG, O'Byrne PM. Targeting membrane-expressed IgE B cell receptor with an antibody to the M1 prime epitope reduces IgE production. Sci Transl Med. 2014 Jul 2;6(243):243ra85. doi: 10.1126/scitranslmed.3008961.
Results Reference
derived
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A Study of MEMP1972A in the Prevention of Allergen-Induced Airway Obstruction in Patients With Mild Asthma (SOLARIO)
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