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

• Status: Recruiting
• Trial end date: 2022-04-25
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to demonstrate that dupilumab treatment improves exercise capacity in patients with moderate-to-severe asthma.

The secondary objectives of the study are:

• To demonstrate that dupilumab treatment increases physical activity of daily living in patients with moderate-to-severe asthma

• To demonstrate that dupilumab treatment improves pre- and post-exercise lung function in patients with moderate-to-severe asthma

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal

Criteria

Key Inclusion Criteria:

• 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

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 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

NOTE: Other protocol defined inclusion/exclusion criteria apply