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A Study of MEMP1972A in the Prevention of Allergen-Induced Airway Obstruction in Patients With Mild Asthma (SOLARIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01196039
Recruitment Status : Completed
First Posted : September 8, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: MEMP1972A Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Choking

Arm Intervention/treatment
Experimental: A Drug: MEMP1972A
Intravenous repeating dose

Placebo Comparator: B Drug: placebo
Intravenous repeating dose

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Change in methacholine challenge PC20 relative to the pre-allergen challenge PC20 [ Time Frame: Day 87 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01196039

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Canada, Alberta
Calgary, Alberta, Canada, T2N 4Z6
Edmonton, Alberta, Canada, T6G1Z1
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Ste. Foy, Quebec, Canada, G1V 4G5
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Stockholm, Sweden, S-14186
Sponsors and Collaborators
Genentech, Inc.
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Study Director: Jeffrey Harris, MD, Ph.D Genentech, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Genentech, Inc. Identifier: NCT01196039     History of Changes
Other Study ID Numbers: MOP4843g
GA01332 ( Other Identifier: Hoffmann-La Roche )
First Posted: September 8, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Airway Obstruction
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Respiratory Insufficiency
Respiration Disorders