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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Matching placebo; Drug: dupilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04203797

R668-AS-1903

2019-002742-20 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

dupilumab

Experimental group

Description:

A loading dose at the start of the treatment followed by once every two weeks (Q2W).

Treatment:

Drug: dupilumab

Matching placebo

Experimental group

Description:

Matching dupilumab

Treatment:

Drug: Matching placebo