Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regeneron Pharmaceuticals
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
A physician diagnosis of asthma
Pre-bronchodilator FEV1 between 30% and 75% predicted at both the screening and baseline visits
Bronchodilator reversibility defined as \>200 mL and 12% increase in FEV1 post-administration of a short-acting beta agonist (SABA). A patient may also qualify if there is a documented history of bronchodilator reversibility or positive methacholine challenge test within 12 months prior to the screening visit
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 propionate ≥250 to 1000 μg twice daily \[BID\] 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/μL for patients not on maintenance OCS at the screening visit
ACQ-5 score ≥1.5 at the screening and baseline visits
You may not be if
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 as described in the protocol
Uncontrolled hypertension at screening or baseline
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-IL4Rα, 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
Clareo Health | A Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Adult Patients With Asthma
