A Study to Evaluate the Safety and Efficacy of HAE1 in Subjects With Moderate to Severe Allergic Asthma

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00406965
First received: November 30, 2006
Last updated: December 31, 2007
Last verified: December 2007
  Purpose

This is a Phase II, multicenter, randomized, double blind, placebo controlled, multiple-dose study designed to evaluate the efficacy, safety, and tolerability of subcutaneously administered HAE1 in subjects 12-75 years old with moderate to severe asthma whose symptoms are inadequately controlled with moderate to high-dose ICS and LABA.


Condition Intervention Phase
Allergic Asthma
Drug: HAE1 (PRO98498)
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of HAE1 (PRO98498) in Subjects With Moderate to Severe Allergic Asthma

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • The primary outcome measure is the change from baseline (Visit 1) in total asthma symptom score to Visit 10 (Day 140).

Secondary Outcome Measures:
  • Incidence and severity of treatment-emergent adverse events and targeted adverse events and incidence of HAE-1 specific antibodies from Visit 1 to the end of the study
  • Change from baseline (Visit 1) in asthma symptom scores (nocturnal, morning, daytime, and total) at Visits 5, 6, 7, 8, and 10 (Days 28, 56, 84, 112, and 140)
  • Change from baseline (Visit 1) in the number of puffs per day of beta2-agonist rescue medication at Visits 5, 6, 7, 8, and 10 (Days 28, 56, 84, 112, and 140)
  • The rate of asthma exacerbations at Visit 10
  • Change from baseline (Visit 1) in the ACQ at Visits 5, 6, 7, 8, 10, 11, 12, 13, and 14 (Days 28, 56, 84, 112, 140, 168, 196, 224, and 252)
  • Change from baseline (Visit 1) in percent predicted forced expiratory volume in 1 second (FEV1) at Visits 5, 6, 7, 8, and 10 (Days 28, 56, 84, 112, and 140).

Estimated Enrollment: 50
Study Start Date: December 2006
Study Completion Date: September 2007
  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed Informed Consent Form(s)
  • Male and females 12-75 years of age with the diagnosis of allergic asthma for 12 months according to the standards of the American Thoracic Society
  • Baseline FEV1 values ≥ 40% to ≤ 80% of the predicted normal value for the subject
  • Demonstration of ≥ 12% increase in FEV1 over baseline value within 30 minutes of taking up to four puffs of albuterol (90 ug/puff)
  • Treatment with ICS in doses equivalent to 250-500 ug fluticasone twice daily (BID) for 8 weeks prior to screening and as needed or regular use of bronchodilator therapy
  • Treatment with a stable regimen of 50 ug salmeterol BID or 12 ug formoterol BID for at least 8 weeks prior to screening (with or without other asthma controller medications)
  • A positive radioallergosorbent test (RAST) to one or more of the pertinent perennial or seasonal allergens
  • Total serum IgE level ≥ 20 to ≤ 1500 IU/mL and body weight between ≥ 40 and ≤ 150 kg
  • Acceptable medical history and physical examination results
  • Demonstrated ability to use Mini-Wright peak flow meter for the measurement of peak expiratory flow (PEF) and a metered dose inhaler (MDI) for administration of albuterol rescue medication
  • Willingness to complete the daily diary cards
  • History of smoking of less than 10 pack-years and no smoking for ≥ 12 months
  • For females of childbearing potential, use an effective method of contraception from screening throughout their duration of study participation (e.g., oral, mechanical, SC, or surgical contraception)
  • Inadequately controlled asthma 4 weeks during the run-in period as demonstrated by either of the following: One or more nighttime awakenings per week or Asthma symptoms during the day requiring rescue medication for 2 or more days per week

Exclusion Criteria:

  • Active lung disease other than asthma
  • Asthma exacerbation requiring treatment with the addition of systemic (oral or IV) corticosteroids or an increase in systemic corticosteroids within 1 month prior to screening or during the run-in period
  • Significant change (e.g., 50% change) in dosage of inhaled corticosteroids in daily dose or dosing schedule within 1 month of prior to the screening visit or during the run-in period
  • Significant medical illness other than asthma
  • Treatment with methotrexate, gold salts, cyclosporine, theophyllines, or macrolide antibiotics within 3 months prior to screening or during the run-in period
  • Treatment with HAE1
  • Any treatment with omalizumab
  • Known hypersensitivity to the ingredients of the HAE1 formulation, to trial rescue medication (albuterol), or related drugs
  • History of acute infectious sinusitis or respiratory tract infection within 1 month prior to screening or during the run-in period
  • Aspirin or other nonsteroidal anti-inflammatory drug-related asthma
  • Allergy vaccination therapy < 3 months of stable maintenance dose prior to screening
  • Treatment with oral or parenteral corticosteroids within 1 month prior to screening or during the run-in period
  • Current treatment with <beta>-blocker medications (e.g., propranolol)
  • Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening
  • Abnormal chest X-ray (excluding changes consistent with asthma) within 12 months prior to screening
  • Clinically significant or active systemic disease (e.g., cancer, neoplasia, infection, hematological, renal, hepatic, coronary heart disease or other cardiovascular diseases, or endocrine or gastrointestinal disease) within 3 months of screening or during the run-in period
  • Inability or unwillingness to comply with study procedures and visits (e.g., spirometry, blood draws, subject diary)
  • History of drug or alcohol abuse
  • Elevated serum IgE levels for reasons other than allergy (e.g., parasitic infection, hyperimmunoglobulin E syndrome, Wiskott-Aldrich syndrome, or bronchopulmonary aspergillosis)
  • Pregnancy or lactation
  • Platelet count ≤ 110,000/mm^3 or ≤ 110 x 10^9/L at screening or the qualifying run-in visit
  • Clinically significant laboratory abnormalities, which would limit participation in the study or interfere in the interpretation of study, or affect subject safety, and evaluations at screening or the qualifying run-in visit
  • Treatment with an investigational drug within 1 month of screening or during the run-in period
  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: NCT00406965

Sponsors and Collaborators
Genentech
Investigators
Study Director: Yamo Deniz, M.D. Genentech
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00406965     History of Changes
Other Study ID Numbers: HAE3973g
Study First Received: November 30, 2006
Last Updated: December 31, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014