Clinical Connection

This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

A study of TEV-53275 given by subcutaneous (under the skin) injection in adult patients with eosinophilic asthma

A research study is testing an investigational drug in adult patients with eosinophilic-type asthma. The research study will also look at safety of the investigational drug. The investigational drug is administered one time and is given as 4 subcutaneous (under the skin) injections. Patients included in the research study will be given either the investigational drug or placebo (inactive), and all patients in the research study will continue taking their regular asthma maintenance medication. If you are included in the research study, the research study will last about 8 months overall and there will be visits to the clinic to assess whether you qualify and about once a month for the first 4 months after enrollment.

Trial ID: NCT04847674

Trial Details

For each patient, the total duration of research study participation is approximately 34 weeks including up to a 2-week screening period, a 2-week run-in period, a 16-week evaluation period, and a follow-up visit 14 weeks after the final visit.

The objective of this study is to evaluate an investigational drug comparing 2 dose strengths to placebo in patients with persistent asthma and an eosinophilic phenotype.

Estimated Enrollment

300 Participants

Phase

Eligibility Criteria

Participants must:

Be male or female age >= 18 years old in the US, with a diagnosis of asthma for at least 6 months as defined by the National Institutes of Health and has been stable without exacerbation or change in medications for at least 1 month.
Be capable of giving signed informed consent.
Have an absolute blood eosinophil count ≥300 cells/μL demonstrated during the screening period.
Current Asthma Therapy: The patient has been maintained for at least 1 month on stable doses of:
- Medium or high dose of inhaled steroids
- Any combination inhaled steroids with long-acting beta-agonists
Be willing to use contraception if of child-bearing age
The patient, as judged by the investigator, is able to continue their current asthma maintenance medications throughout the research study.

Participants must not:

Have life threatening asthma
Have a suspected bacterial or viral infection that has not resolved at least 2 weeks before the screening period.
Have a confirmed infection with COVID-19 within 3 months prior to the screening visit.
Have a history of cancer diagnosed within 5 years other than fully resected basal cell carcinoma of the skin.
Be pregnant or breastfeeding or plans to become pregnant during the study.
Currently smoke or vape

What Will Happen in This Study

There are 4 periods to this research study: screening, run-in period, double-blind investigational drug or placebo administration period, and follow-up. You may be in this research study for up to 34 weeks. You will need to visit the research site about 10 times during the research study. You will also be contacted about 3 times by phone while you are in the follow-up period of the study. Screening will last no more than 2 weeks. More than 1 visit to the research site may be needed. Your medical history will be reviewed. You will be asked about your asthma symptoms and medications during the last year. If you meet all the criteria to take part in the research study, you will enter the run-in period. You will be able to continue using your asthma maintenance medication (long-acting medication), but your rescue medication will be discontinued. You will receive a research study approved rescue inhaler for use as needed. This period will last for approximately 14 days. You will need to visit the research site to be assessed at least 14 days before starting the evaluation period. Provided you still meet all the criteria to take part in the research study after the run-in period, you will enter the evaluation period.

You will visit the site to confirm you still qualify for the research study and if so, to receive the study drug. The study drug will be given to you as subcutaneous (SC) injections. Subcutaneous injections are injections under the skin which are given by using a very small syringe and needle. You will receive 4 SC injections in the abdomen. After 16 weeks you will start the follow-up period. You will be called 3 times (every 4 weeks) to check your asthma symptoms, possible COVID-19 symptoms, any changes in your health and any medications you are taking. After these phone calls, you will need to return to the research site for final safety assessments.

You will need to travel to one of the study clinics taking part in this clinical trial.

Sites are located in the cities/states identified with the red pin:

Frequently Asked Questions (FAQs)

Will I get paid to be a part of this clinical trial?

There are no costs for you if you take part. You will receive the researcg study drug (or placebo) and the research study approved rescue inhalers at no cost to you and you will not be charged for any research study related procedures.

Any reasonable journey costs (for example cost of fuel, bus or railway tickets) will be reimbursed to you, provided they are supported by valid receipts. You will not receive any payment for taking part in this research study.

What is a placebo?

In order to understand if the study drug works, medical researchers are comparing the study drug to a saltwater placebo. A placebo looks like the study drug being tested but does not contain the medication.

All study volunteers will receive the same level of quality care regardless of if they are assigned to the study vaccine or the placebo.

How can I check to see if I’m eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

What does a typical research study look like?

A research plan or protocol is created that outlines how trial participants may receive interventions which can include investigational medications, devices, or procedures. The trial may compare a new medical approach to a standard treatment option already available, to a placebo with no active investigational medication, or to no intervention at all. The trial team will share more details before you participate.

Can I quit the trial at any time?

Study volunteers have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the participant’s safety, or if the participant no longer meets the study requirements.

What personal information is collected about you for the study?

The study doctor and other study staff will collect your personal information. This may include:

Your name, address, telephone number, health insurance number where applicable.
Your age, sex, ethnic and racial background.
Lifestyle information; health and medical history.
Your study treatments and response to study treatments.
Data resulting from testing your biological samples.

Who has access to your personal information?

All your personal information collected for this research study will be securely stored in the study medical records at the study site. Sponsor staff, review boards and ethics committees (that approve and monitor studies), and others who have a need to know such as our data hosting provider, and government regulators may check the study records. This is done to make sure that the research study is being run properly. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicine Agency (EMA) or others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify clinical trial procedures and/or data. If you share your personal data to contact a site, that data will be used by TrialScope to contact you about clinical trials and related information.