A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma

NCT04195958 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: ML41615
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 12

Brief Summary

This study will assess the effect of omalizumab on exercise capacity, physical activity, and sleep quality after 24 weeks of treatment in participants with moderate to severe allergic asthma. Exercise capacity will be assessed using cardiopulmonary exercise testing (CPET). Physical activity and sleep quality will be assessed with a wearable physical activity and sleep monitor. The study will consist of a 4-week screening period, a 24-week treatment period, and a 4-week safety follow-up. Approximately 60 participants will be enrolled, and omalizumab will be dosed according to the approved United States Package Insert (USPI) dosing table.

Conditions

Moderate-to-severe Allergic Asthma

Outcome Measures

Primary Outcomes (1)

• Change From Baseline at Week 24 in Endurance Time (Minutes) During Cardiopulmonary Exercise Testing (CPET) at a Constant Work Rate (CWR)

  This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.

  From Baseline to Week 24

Secondary Outcomes (6)

• Change From Baseline at Week 24 in Physical Activity (Minutes/Day) as Assessed by a Wearable Physical Activity and Sleep Monitor

  From Baseline to Week 24

• Change From Baseline at Week 24 in Dynamic Hyperinflation at Isotime, as Measured by Inspiratory Capacity During CPET at a CWR

  From Baseline to Week 24

• Change From Baseline at Week 24 in Sleep Efficiency as Assessed by a Wearable Physical Activity and Sleep Monitor

  From Baseline to Week 24

• Percentage of Participants With Adverse Events

  From Baseline to Week 28

• Percentage of Participants With Serious Adverse Events

  From Baseline to Week 28

Study Arms (1)

Omalizumab

EXPERIMENTAL

Drug: Omalizumab

Interventions

Omalizumab DRUG

Omalizumab will be administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency will be determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.

Omalizumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician-diagnosed asthma for at least 12 months prior to screening
• Documented history of positive skin test or in vitro reactivity to a perennial aeroallergen
• Able to comply with asthma control medication adherence, digital monitoring data collection, and eDiary requirements during screening period
• Able to safely complete incremental exercise tolerance at screening
• Pre-bronchodilator FEV1 of 40%-80% of predicted at screening
• Documented history of variable airflow obstruction or hyper-responsiveness within 12 months of study entry
• On inhaled corticosteroids (ICS) therapy at a total daily dose greater than or equal to (≥)500 micrograms (ug) of fluticasone propionate or equivalent and at least one second controller (LABA, LAMA, LTRA) for ≥3 months prior to screening
• Uncontrolled asthma during the screening period, defined as an ACQ-5 ≥0.75 score
• Sleep disturbance due to asthma (e.g. cough, wheezing etc.) in the opinion of the investigator
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to use adequate contraception during the treatment period and for 60 days after the final dose of study drug.

You may not qualify if:

• Known history of anaphylaxis/hypersensitivity to omalizumab
• Treatment with investigational drugs within 12 weeks or 5 half-lives (whichever is longer) prior to screening
• Treatment with monoclonal antibodies (e.g., omalizumab, mepolizumab, dupilumab) for 6 months prior to screening
• Maintenance oral corticosteroid therapy, defined as daily or alternate-day oral corticosteroid within 3 months prior to screening or during the screening period
• Treatment with systemic (oral, IV, or IM) corticosteroids within 4 weeks prior to screening or during the screening period
• Isolated diagnosis of exercise induced asthma without chronic symptoms
• History of interstitial lung disease, COPD, or other clinically significant lung disease other than asthma
• Current malignancy or history of malignancy within 5 years prior to screening
• Unable to complete cardiopulmonary exercise testing and/or perform physical activity due to underlying cardiac, neurologic or orthopedic conditions
• Ongoing physician-treated sleep disorder that is unrelated to asthma within 6 months prior to screening
• Current smoker or past smoker with \>10 pack years
• Known HIV infection at screening
• Known acute or chronic infections with hepatitis C virus (HCV) and hepatitis B virus (HBV) at screening
• Infection that resulted in hospital admission, required treatment with intravenous or intramuscular antibiotics within 4 weeks prior to screening, or any active infection that required treatment with oral antibiotics within 2 weeks prior to screening
• Active tuberculosis requiring treatment within 12 months prior to screening

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (12)

Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Broward Research Center

Pembroke Pines, Florida, 33024, United States

Location

University of Iowa Hospitals & Clinics; Internal Medicine

Iowa City, Iowa, 52242, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-0934, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

American Health Research Inc.

Charlotte, North Carolina, 28277, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44016, United States

Location

Temple Uni Medical Center; Pulmonary & Critical Care Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Swedish Health Services

Seattle, Washington, 98122, United States

Location

MeSH Terms

Interventions

Omalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Limitations and Caveats

This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on this, there were not enough participants enrolled to perform a meaningful analysis.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 12, 2019
• Study Start: November 30, 2020
• Primary Completion: October 18, 2021
• Study Completion: October 18, 2021
• Last Updated: March 15, 2022
• Results First Posted: March 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

US (12)