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

NCT04203797 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: R668-AS-19032019-002742-20
• Study Type: interventional
• Target: 40
• Locations: 5 countries
• Sites: 30

Brief 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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 12 in Constant Work Rate Exercise Endurance Time - CWRET (Constant Work Rate Exercise Test)

  CWRET (Constant Work Rate Exercise Test) will be performed on an electromagnetically-braked cycle ergometer in an exercise physiology laboratory overseen by a trained pulmonologist or medical doctor designee.

  Up to week 12

Secondary Outcomes (4)

• Change From Baseline to Week 12 in Average Number of Steps Walked Per Day

  Up to week 12

• Change From Baseline to Week 12 in Total Energy Expenditure

  Up to week 12

• Change From Baseline to Week 12 in the Mean Duration of Moderate-to-vigorous Physical Activity

  Up to week 12

• Change From Baseline to Week 12 in Pre- and Post-exercise Forced Expiratory Volume in One Second (FEV1)

  Up to week 12

Study Arms (2)

dupilumab

EXPERIMENTAL

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

Drug: dupilumab

Matching placebo

EXPERIMENTAL

Matching dupilumab

Drug: Matching placebo

Interventions

dupilumab DRUG

Pre-filled syringe administered by subcutaneous (SC) injections

Also known as: Dupixent®, SAR231893

dupilumab

Matching placebo DRUG

Pre-filled syringe administered by subcutaneous (SC)

Matching placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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 qualify 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (30)

Palos Verdes Medical Group (PVMG); Peninsula Research Associates (PRA)

Rolling Hills Estates, California, 90274, United States

Location

UCLA Medical Center - Harbor

Torrance, California, 90509, United States

Location

Allianz Research Institute

Westminster, California, 92683, United States

Location

University of Iowa Hospitals & Clinics-Roy J. and Lucille A. Carver College of Medicine

Iowa City, Iowa, 52242, United States

Location

University Of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Infinity Medical Research

North Dartmouth, Massachusetts, 02747, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

American Health Research

Charlotte, North Carolina, 28277, United States

Location

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Regeneron Study Site

Hendersonville, Tennessee, 37075, United States

Location

The University of Texas Medical School at Houston

Houston, Texas, 77030, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

CHU Dijon

Dijon, Bourgogne-Franche-Comté, 21000, France

Location

CHU Reims

Reims, Marne, 51092, France

Location

CHU de Strasbourg - Nouvel Hopital Civil

Strasbourg, 67091, France

Location

Praxis Dr. M. Rolke u. Dr. P. Rueckert

Aschaffenburg, Bavaria, 63739, Germany

Location

Regeneron Study Site

Frankfurt am Main, Hesse, 60389, Germany

Location

IKF Pneumologie GmbH & Co. KG - Institut fuer klinische Forschung Pneumologie Frankfurt (Clinical Research Centre Respiratory Medicine) to IKF Pneumologie Frankfurt GmbH & Co KG.

Frankfurt am Main, Hesse, 60596, Germany

Location

Regeneron Study Site

Hanover, Lower Saxony, 30625, Germany

Location

Regeneron Study Site

Koblenz, Rhineland-Palatinate, 56068, Germany

Location

IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz

Mainz, Rhineland-Palatinate, 55128, Germany

Location

Regeneron Study Site

Großhansdorf, Schleswig-Holstein, 22977, Germany

Location

KLB - Gesundheitsforschung Luebeck GmbH

Lübeck, Schleswig-Holstein, 486344, Germany

Location

Regeneron Study Site

Berlin, 12159, Germany

Location

Regeneron Study Site

Lubin, Lower Silesian Voivodeship, 59-300, Poland

Location

Centrum Medycyny Oddechowej, Mroz Spolka Jawna

Bialystok, 15-044, Poland

Location

Lekarze Specjalisci - J. Malolepszy i Partnerzy

Wroclaw, 54-239, Poland

Location

Hospital Universitario de Bellvitge

Barcelona, 08907, Spain

Location

Hospital General Universitario Gregorio Maranon (HGUGM) - Instituto de Investigacion Sanitaria Gregorio Maranon (IiSGM)

Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Asthma

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trials Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 18, 2019
• Study Start: July 16, 2020
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
• Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (eg, FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

Locations

PL (3); ES (2); US (13); DE (9); FR (3)