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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01196039
First received: September 3, 2010
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This Phase II, double-blind, placebo-controlled, randomized, parallel-group stud y is designed to evaluate the efficacy, safety and tolerability of MEMP1972A whe n administered to patients by intravenous (IV) infusion for the treatment of all ergen-induced asthma.


Condition Intervention Phase
Asthma
Drug: MEMP1972A
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Genentech:

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) [ Time Frame: Between 3 and 7 hours after allergen challenge at Day 86 after the first dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change in methacholine challenge PC20 relative to the pre-allergen challenge PC20 [ Time Frame: Day 87 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: December 2010
Study Completion Date: January 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: MEMP1972A
Intravenous repeating dose
Placebo Comparator: B Drug: placebo
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196039

Locations
Canada, Alberta
Calgary, Alberta, Canada, T2N 4Z6
Edmonton, Alberta, Canada, T6L5X8
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
Sweden
Stockholm, Sweden, S-14186
Sponsors and Collaborators
Genentech
Investigators
Study Director: Jeffrey Harris, MD, Ph.D Genentech
  More Information

No publications provided by Genentech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01196039     History of Changes
Other Study ID Numbers: MOP4843g, GA01332
Study First Received: September 3, 2010
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Airway Obstruction
Asthma
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 19, 2014