Last updated on July 2020

A Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Patients With Asthma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Allergies & Asthma | Asthma (Pediatric) | Asthma
  • Age: Between 18 - 55 Years
  • Gender: Male or Female

Key Inclusion Criteria:

  • A physician diagnosis of asthma
  • Stable background therapy for at least 3 months with a stable dose 4 weeks prior to the baseline visit of a medium-to-high dose ICS [fluticasone >250 to 1000 g BID or equivalent] in combination with at least a second controller medication (eg, long-acting beta agonist [LABA], long-acting muscarinic antagonist [LAMA], leukotriene receptor antagonist [LTRA], theophylline, etc.); a third controller is allowed and with the same stabilization requirements
  • Blood eosinophil count 300 cells/L or on maintenance OCS at the screening visit
  • ACQ-5 score 1.5 at the screening and baseline visits

Key Exclusion Criteria:

  • Body mass index >35 kg/m2 at screening
  • Current smoking, vaping or tobacco chewing or cessation of any of these within 6 months prior to randomization, or >10 pack years smoking history
  • Patients who require supplemental oxygen at screening
  • Clinically significant cardiac disease
  • Uncontrolled hypertension
  • Participation in exercise or physical rehabilitation program within last 6 months prior to screening or planned during the study
  • Previous use of dupilumab
  • Anti-IgE therapy (eg, omalizumab [Xolair]) within 130 days prior to visit 1 or any other biologic therapy (including anti-IL5, anti-IL-5R, anti-IL4R, anti-IL-13 mAb) or systemic immunosuppressant (eg, methotrexate, any anti-tumor necrosis factor mAbs, Janus kinase inhibitors, B- and/or T-cell targeted immunosuppressive therapies) to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis) and other diseases, within 3 months or 5 half-lives prior to screening, whichever is longer
  • Exposure to another investigative drug (monoclonal antibodies as well as small molecules) within a period prior to screening, of <3 months or <5 half-lives (whichever is longer)
  • Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
  • Women of childbearing potential (WOCBP)* who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the last dose

NOTE: Other protocol defined inclusion/exclusion criteria apply

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.