GSK ENDURA and VIGILANT | Clinical Research Trial Listing - PPD

Struggling with shortness of breath?

Join VIGILANT, a clinical study for Chronic Obstructive Pulmonary Disease (COPD).

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Informed consent

To check your eligibility for clinical studies conducted by GSK on Chronic Obstructive Pulmonary Disease. The Sponsor has engaged us, Pharmaceutical Product Development, LLC and its affiliated companies, to conduct recruitment activities on the Sponsor’s behalf. To help determine whether you may be eligible for the study, we will ask you a few personal and health-related questions through a short questionnaire.

If you agree, your personal information will be retained to assess your suitability for this research study and to recontact you using the contact methods you provide via the contact form (e.g., SMS, phone calls, and/or emails).

If you pre-qualify for one of these studies, we will collect and share your name and contact details with the medical center involved and the contracted service providers. Under applicable data protection laws, GSK is responsible for protecting your information and ensuring you can exercise your rights. For more information on how your personal information is used and your rights, please read the GSK US Privacy Notice.

All the information requested in this pre-qualification questionnaire is necessary to determine your pre-qualification for these studies. If you do not provide the requested information or do not agree to the processing of your information, you may not be able to pre-qualify for the studies. Please confirm that we have your permission to process your personal information as described above and in GSK US Privacy Notice.

You have the right to withdraw your consent to the processing of your information at any time by sending an email to CRGComplianceContact@thermofisher.com. If you withdraw your consent, it does not affect the processing of your information before your withdrawal.

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What is COPD?

Chronic Obstructive Pulmonary Disease (COPD) is a lung disease that makes it hard to breathe.

The main causes are smoking, long-term exposure to harmful chemicals, and air pollution.

Symptoms may include:

Coughing

Wheezing

Shortness of breath

Chest tightness

Acute flare-ups

How is COPD Treated?

There is currently no cure for COPD.

Treatments include using inhalers, taking medications to reduce COPD exacerbations, and sometimes using oxygen therapy.

However symptoms worsen over time, because of this, doctors are looking for safer, more effective treatment options.

About the VIGILANT study

This study is testing an investigational drug called depemokimab compared to placebo for the treatment of COPD. “Investigational” means that it has not been approved by any regulatory bodies. A placebo (“dummy drug”) looks like the study drug but does not contain the active ingredient being tested.

You will be randomly assigned (by chance) to one of the following groups:

Study drug
Placebo (a substance that looks like the investigational drug but has no active ingredients).

Neither you nor the study doctor will know what you will be taking.

This helps researchers compare the doses and decide which one works best and is safest.

Study Periods

The study will consist of 3 main periods:

A 14–28-day Screening Period to make sure you qualify for the study.

A 1 to 3-year Treatment Period during which you will receive the investigational drug or placebo. The duration will depend on the time you enter the study.

A Post-Treatment Period consisting of An Exit Visit

AND a Follow-up Visit.

You may qualify to take part in this study if you:

Are 40-75 years old.

Have moderate to severe COPD.

Other criteria to take part apply which the study doctor will discuss with you.

See If You Can Take Part

Those Who Qualify May Receive:

Compensation for travel.

No-cost study-related care.

No-cost investigational drug.

Your safety is our top priority.

The VIGILANT study follows strict international safety standards and is closely monitored by medical experts at every step.

Participants receive regular health checks, lab tests, and ongoing monitoring.

Any side effects are carefully tracked and managed.

Independent medical committees review safety data throughout the study.

Where is the study available?

This is a multicenter study, meaning it is being conducted at several clinical sites.

Find a study location near you

Frequently Asked Questions (FAQs)

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What is a clinical trial?

Researchers conduct clinical studies, also known as clinical trials, to learn if an investigational medication is safe and effective for people who have certain health conditions. Clinical studies follow strict scientific standards and regulations to ensure they produce the best data for health care decision making and protect the participants.

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What is the purpose of the study?

This study is being done to test if depemokimab:

Can reduce COPD flare-ups
Make you feel better
Is safe
Is well tolerated
Works

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What is a placebo?

Some participants may receive a placebo.

A placebo looks like the study medication but does not contain active treatment.

This helps researchers compare results and understand how well the treatment works.

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Is the investigational drug safe?

Like all medicines, depemokimab may cause side effects – although not everyone gets them. Some side effects could be:

Itchy skin
Local injection site reaction (could include pain, redness, swelling and itching)
Headache
Fatigue

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Can I quit the trial at any time?

Yes, you have the right to drop out of the trial at any time for any reason, or no reason at all.

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What are the next steps?

To join this study, you must read and sign an informed consent document to show that you understand the study and what is required. A study team member will explain the study’s procedures, possible benefits and risks, and answer any questions you may have prior to you signing the form.

Take the next step

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