A Study of MEMP1972A in the Prevention of Allergen-Induced Airway Obstruction in Patients With Mild Asthma (SOLARIO)
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
2 other identifiers
interventional
29
2 countries
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 asthma
Started Dec 2010
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2010
CompletedFirst Posted
Study publicly available on registry
September 8, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedNovember 2, 2016
November 1, 2016
8 months
September 3, 2010
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Late airway response (LAR) area under the concentration-time curve (AUC) (percent decline in forced expiratory volume in 1 second [FEV1] over time)
Between 3 and 7 hours after allergen challenge at Day 86 after the first dose
Secondary Outcomes (3)
Maximum percent decline in FEV1
Immediately prior to the allergen challenge to between 3 and 7 hours after allergen challenge on Day 86 after the first dose
Change in methacholine challenge PC20 relative to the pre-allergen challenge PC20
Day 87
Maximum percent decline in FEV1 and early airway response (EAR) AUC (percent decline in FEV1 over time)
Between 0 and 3 hours after post-treatment allergen challenge
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (7)
Unknown Facility
Calgary, Alberta, T2N 4Z6, Canada
Unknown Facility
Edmonton, Alberta, T6G1Z1, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 1M9, Canada
Unknown Facility
Hamilton, Ontario, L8N 3Z5, Canada
Unknown Facility
Ste. Foy, Quebec, G1V 4G5, Canada
Unknown Facility
Saskatoon, Saskatchewan, S7N 0W8, Canada
Unknown Facility
Stockholm, S-14186, Sweden
Related Publications (1)
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.
PMID: 24990880DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jeffrey Harris, MD, Ph.D
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2010
First Posted
September 8, 2010
Study Start
December 1, 2010
Primary Completion
August 1, 2011
Study Completion
January 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11