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Monoclonal Antibodies

Dupilumab for Asthma (EPIPHANY Trial)

Phase 4

Recruiting

Led By Kelan Tantisira, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stable asthma medications: No change in asthma medications for the past 2 months, including use of medium or high dose inhaled corticosteroids (ICS) AND use of an additional asthma controller medication

Baseline poor or uncontrolled asthma evidenced by either bronchodilator reversibility or methacholine responsiveness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed through study completion, an average of 60 weeks

Awards & highlights

EPIPHANY Trial Summary

This trial will test two approved biologic therapies to see how well each patient responds to them. By analyzing genomic and biologic data from biosamples, the study aims to understand severe asthma better and improve

Who is the study for?

This trial is for asthma patients who've been on stable medication for 2 months, with poor or uncontrolled symptoms. They must be willing to follow the study rules and not use any other biologics, have no recent respiratory infections, and agree to lifestyle requirements. Pregnant women, heavy smokers, those with a high BMI (>38), or anyone on certain immune therapies can't join.Check my eligibility

What is being tested?

The study tests how well patients respond to two approved asthma treatments: Benralizumab and Dupilumab. It uses genomic data from participants' biosamples to understand treatment effects better and aims at personalizing therapy based on genetic response patterns.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones associated with these types of drugs include injection site reactions, possible allergic responses, headache, fatigue, and in some cases an increased risk of infection.

EPIPHANY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My asthma medication has been the same for the last 2 months.

Select...

My asthma is poorly controlled or gets worse with certain tests.

EPIPHANY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed through study completion, an average of 60 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed through study completion, an average of 60 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed through study completion, an average of 60 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Predicting asthma outcomes and therapeutic responses

Responses to the biologic therapies at the single cell level

Unique asthma subgroups clinical and molecular endotype approaches

Secondary outcome measures

Asthma Control Questionnaire (ACQ)

Asthma Quality of Life Questionnaire (AQLQ)

CompEx events

+1 more

EPIPHANY Trial Design

2Treatment groups

Active Control

Group I: DupilumabActive Control1 Intervention

600 mg once subcutaneously (given as two 300 mg injections), followed by 300 mg subcutaneously every other week.

Group II: BenralizumabActive Control1 Intervention

30 mg subcutaneously every 4 weeks.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,847 Previous Clinical Trials

47,818,506 Total Patients Enrolled

278 Trials studying Asthma

112,881 Patients Enrolled for Asthma

University of California, San DiegoLead Sponsor

1,127 Previous Clinical Trials

1,552,799 Total Patients Enrolled

4 Trials studying Asthma

32,333 Patients Enrolled for Asthma

Mayo ClinicOTHER

3,232 Previous Clinical Trials

3,771,981 Total Patients Enrolled

6 Trials studying Asthma

417 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll participants for this clinical trial at the moment?

"Affirmative. Information from clinicaltrials.gov indicates that this medical research is presently seeking volunteers. The trial was initially shared on February 19th, 2024 and last revised on April 23rd, 2024. It aims to recruit a total of 120 participants distributed among three locations."

Answered by AI

What is the current number of patients being recruited for participation in this medical study?

"Indeed, the details available on clinicaltrials.gov suggest that this investigation is actively pursuing suitable candidates. Originally listed on February 19th, 2024, and subsequently revised on April 23rd of the same year, this trial aims to recruit a total of 120 individuals from three distinct sites."

Answered by AI

What are the main goals being pursued in this medical study?

"The primary objective of this research, to be assessed at the end of a 16-week period for each biological agent, aims to evaluate responses to these therapies at the individual cell level. Secondary endpoints encompass the Asthma Control Questionnaire (ACQ), which is a concise tool comprising six questions used to gauge asthma control and any changes therein due either spontaneously or through treatment; CompEx events, a combined measure specific to asthma that merges clinically significant deteriorations documented by diary entries with exacerbations, thereby enhancing statistical power compared to solely relying on exacerbation data — CompEx events include both exacerbations and deteriorating incidents; and finally, the Ast"

Answered by AI

Are individuals aged 45 and above eligible for participation in this study?

"Participants must be aged between 18 and 75 years to qualify for this research project. It is noteworthy that there are 135 investigations focusing on individuals below the age of 18, while there are 210 studies targeting those over the age of 65."

Answered by AI

Recent research and studies

American Journal of Respiratory and Critical Care MedicineJournal

Identification of Asthma Phenotypes Using Cluster Analysis in the Severe Asthma Research Program

Moore, Wendy C., Deborah A. Meyers, Sally E. Wenzel, W. Gerald Teague, Huashi Li, Xingnan Li, Ralph D'Agostino Jr., et al.. 2010. “Identification of Asthma Phenotypes Using Cluster Analysis in the Severe Asthma Research Program”. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society. doi:10.1164/rccm.200906-0896oc.

clinicaltrials.govStudy

Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping

Praveen Akuthota 2024. "Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06385236.

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