A Dose-Finding Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Adalimumab in Subjects With Refractory Asthma

Abbott

Status and phase

Withdrawn

Phase 2

Conditions

Asthma

Treatments

Drug: Humira (adalimumab)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00512863

M05-757

Details and patient eligibility

About

To evaluate the efficacy of SC injections of 3 regimens of adalimumab vs. placebo in the change in post-bronchodilator FEV1 from Baseline to Week 16 when used in the treatment of refractory asthma.

Enrollment

272 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Documented history of refractory asthma, as defined by the American Thoracic Society,31 defined as 1 major and at least 2 minor criteria
Actual or documented history of reversible airway obstruction
Baseline FEV1 of 40% - 80% of the predicted for height, age, and sex at Screening, as demonstrated 6 or more hours after a short-acting -agonist and/or 24 or more hours after a long-acting -agonist
History of at least 1 asthma exacerbation leading to oral, IV or IM corticosteroid or ER/Urgent Care Center visit or hospitalization within the past year prior to Screening. This asthma exacerbation should not have been within 30 days prior to Screening
Adequate cardiac, renal and hepatic function as determined by the principal investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits
Subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication

Exclusion criteria

Active lung diseases (e.g., bronchitis, chronic obstructive pulmonary disease [COPD], interstitial lung disease, pulmonary fibrosis) other than asthma
Current treatment for corticosteroid-resistant asthma (e.g., methotrexate [MTX], cyclosporine, gold salts, troleandomycin, immune globulin intravenous [IGIV], mycophenolate mofetil)
History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma - in-situ of the cervix.
History of listeria, human immunodeficiency virus (HIV), chronic or active Hepatitis B, an immunodeficiency syndrome, central nervous system (CNS) demyelinating disease or active TB
Females who are pregnant or will not discontinue breast-feeding.
Subject with a history of clinically significant drug or alcohol abuse in the last year
Subjects with a poorly controlled medical condition.
Abnormal, clinically significant screening laboratory and other analyses (including ECG).
Subjects with any prior exposure to Tysabri® (natalizumab)
Prior treatment with any TNF antagonist, including adalimumab