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Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD

NCT07059091 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2026-02-17

No results posted yet for this study

Summary

This research is being done to test if a drug called omalizumab can help people with Chronic Obstructive Pulmonary Disease (COPD) and allergies.

Each participant will be in the study for about 16 months, including 1-3 months of screening, 12 months of receiving the study drug at a clinic, and a follow-up call one month after your final clinic visit.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Allergies

Interventions

DRUG

Omalizumab (Xolair®)

The study drug (omalizumab or placebo) will be given as a subcutaneous injection, which means an injection into the fat layer just under the skin in your arm or leg. This is similar to an insulin injection and not as deep as a typical vaccine injection. After the injection, participants will be monitored for any side effects. The study team will determine the dose and how often the injection is given based on the participant's weight and blood test results. Injections will be either be given monthly, 12 doses, or twice per month, 24 doses. All injections will be given at the clinic.

DRUG

Sodium Chloride (NaCl) 0.9 %

The study drug (omalizumab or placebo) will be given as a subcutaneous injection, which means an injection into the fat layer just under the skin in your arm or leg. This is similar to an insulin injection and not as deep as a typical vaccine injection. After the injection, participants will be monitored for any side effects. The study team will determine the dose and how often the injection is given based on the participant's weight and blood test results. Injections will be either be given monthly, 12 doses, or twice per month, 24 doses. All injections will be given at the clinic.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Genentech, Inc.

    collaborator INDUSTRY

  • American Lung Association Asthma Clinical Research Centers

    collaborator OTHER

  • American Lung Association

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Nirupama Putcha · Johns Hopkins School of Medicine

  • Elizabeth Sugar, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-12
Primary Completion
2031-01-31
Completion
2031-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07059091 on ClinicalTrials.gov