Your session is about to expire
← Back to Search
Monoclonal Antibodies
Dupilumab for Allergic Asthma
Phase 2
Recruiting
Led By Sunil K Ahuja, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 18 weeks
Awards & highlights
Study Summary
This trial tests whether a drug and allergen exposure can help treat asthma.
Who is the study for?
Adults aged 18-65 with perennial nasal allergy for at least 2 years, positive skin test to house dust mites, and asthma can join. They must use reliable birth control if applicable, not smoke currently or heavily in the past, have COVID-19 vaccination or recent infection proof, and test negative for SARS-CoV-2 before visits.Check my eligibility
What is being tested?
The trial tests dupilumab's effects on allergic reactions by exposing participants to house dust mites in a controlled setting. Some will receive dupilumab while others get a placebo to compare outcomes.See study design
What are the potential side effects?
Dupilumab may cause injection site reactions, eye irritation or inflammation (pink eye), joint pain, and could potentially increase the risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 18 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 18 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall change in ACC HDM exposure-induced nasal airway gene expression profile
Secondary outcome measures
Average symptom scores (Instantaneous Summated Symptom Score-Average: iSSS-AV)
Overall change in ACC HDM during first HDM exposure-induced peripheral blood gene expression
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Maladaptive Phenotypes randomized to study drugExperimental Treatment2 Interventions
This group will be comprised of the Maladaptive-A and Maladaptive-B subgroup and will consist of the maladaptive phenotype participants identified during the initial HDM ACC challenge administered the study drug.
Group II: Adaptive Phenotypes randomized to study drugActive Control2 Interventions
This group will be comprised of the Adaptive-A and Adaptive-B subgroup and will consist of the adaptive phenotype participants identified during the initial HDM ACC challenge, administered the study drug.
Group III: Maladaptive Phenotype randomized to placeboPlacebo Group2 Interventions
This group will be comprised of the Maladaptive-A and Maladaptive-B subgroup and will consist of the maladaptive phenotype participants identified during the initial HDM ACC challenge administered the placebo.
Group IV: Adaptive Phenotype randomized to placeboPlacebo Group2 Interventions
This group will be comprised of the Adaptive-A and Adaptive-B subgroup and will consist of the adaptive phenotype participants identified during the initial HDM ACC challenge, administered the placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~12230
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,322 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,149 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
620 Previous Clinical Trials
380,297 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had issues with severe nasal problems or deformities.I have a long-term lung condition that is not asthma.I have taken JAK-1 inhibitors in the last 3 months.I have atopic dermatitis.My eye condition is not related to seasonal allergies.I will test negative for COVID-19 before each treatment visit.I am between 18 and 65 years old.I have not received a live vaccine in the last 30 days nor plan to during the study.My asthma shows improvement in lung function tests by at least 10% in the last year.I am a woman who can have children and have a negative pregnancy test.I have taken steroids in the past month.I am currently infected with worms.I have received biologic treatments within the last year.I have never smoked or quit smoking long ago with less than 20 pack-years.I have had year-round nasal allergy symptoms for at least 2 years.I can avoid taking certain medications as required by the study.I have a history of dry eye syndrome.I have had year-round nasal allergy symptoms for at least 2 years.I cannot stop taking my nasal or asthma meds for doctor visits.I have symptoms from being around indoor pets.
Research Study Groups:
This trial has the following groups:- Group 1: Maladaptive Phenotype randomized to placebo
- Group 2: Adaptive Phenotype randomized to placebo
- Group 3: Adaptive Phenotypes randomized to study drug
- Group 4: Maladaptive Phenotypes randomized to study drug
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applicants beyond the age of 25 being considered for participation in this research?
"The eligibility criteria for participation in this trial stipulates that the lower age bound is 18 and the upper limit of 65."
Answered by AI
Am I eligible to be a participant in this investigation?
"This research is searching for 88 participants that suffer from asthma and allergies, aged between 18 to 65. Candidates must be within these parameters in order to qualify."
Answered by AI
Is the Maladaptive Phenotypes randomized to study drug a safe option for patients?
"The safety of the Maladaptive Phenotypes randomized to study drug has been assessed as a 2 on our internal scale, due to its Phase 2 status. Thus far, there is evidence that suggests it may be safe but no data confirming efficacy."
Answered by AI
Is enrollment for this research project currently on-going?
"Evidently, this medication trial is no longer searching for volunteers. Initially posted on March 1st 2023 and last revised on January 27th 2023, it has now been superseded by the other 319 trials recruiting patients at present."
Answered by AI
Who else is applying?
What site did they apply to?
University of Texas Health Science Center at San Antonio
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
I can begin ASAP and I have an open schedule .. when does it begin and is it a paid study?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I read the discription and I am interested.
PatientReceived 2+ prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger