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28 Dupilumab Trials Near You
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerDupilumab for Eosinophilic Gastrointestinal Diseases
Columbus, Ohio
This trial is testing a new drug called dupilumab to see if it can help people aged 12 and older who have a condition that causes too many white blood cells to gather in their stomach and small intestine, leading to inflammation and damage. The study will compare the effects of dupilumab to another treatment and will also look at side effects and how the body reacts to the drug.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:12+
Key Eligibility Criteria
Disqualifiers:Weight < 40 Kg, Helicobacter Pylori, Crohn's, Others
22 Participants Needed
Dupilumab for Eczema
Gahanna, Ohio
The primary objective of the study is to assess the long-term safety of dupilumab in pediatric participants with AD.
The secondary objectives of the study are:
* To assess the long-term efficacy of dupilumab in pediatric participants with AD
* To assess the trough concentrations of functional dupilumab in serum and the immunogenicity in pediatric participants with AD after re-treatment with dupilumab
Optional Pre-filled Pen (PFP) Sub-Study in pediatric patients ≥2 to \<12 years of age with AD
Co-Primary Objectives are:
* To evaluate the pharmacokinetic (PK) of dupilumab PFPs
* To evaluate the safety of dupilumab PFPs
Secondary Objective is:
- To evaluate the immunogenicity of dupilumab PFPs
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:6 - 17
Key Eligibility Criteria
Disqualifiers:Severe Illness, Endoparasitic Infections, Others
Must Be Taking:Dupilumab
880 Participants Needed
Upadacitinib vs Dupilumab for Eczema
Canal Winchester, Ohio
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Topical therapies applied over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in pediatric participants with moderate to severe AD who are candidates for systemic therapy. Adverse events and change in the disease activity will be assessed.
Upadacitinib is an approved drug for treating AD patients aged 12 or older. Participants will receive upadacitinib (given as daily dose) or dupilumab (given at label indicated dose every 2 or 4 weeks). Participants will be stratified depending on disease severity, age and response to previous treatment. There is 1 in 5 chance for participants to receive dupilumab during the randomized cohort. Approximately 675 participants aged 2 to less than 12 years of age will be enrolled in this study at approximately 150 sites worldwide. The study population (As defined by participants age or prior treatment) to be enrolled in the study is dependent on local regulatory requirement and/or agreement.
Participants will receive upadacitinib oral tablets once daily (or oral solution twice a day) for 160 weeks, or dupilumab as per its label for 52 weeks, and followed for 30 days after the last dose of upadacitinib and at least 12 weeks after the last dose of dupilumab.
There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by clinical assessments, blood tests, checking for side effects and completing questionnaires.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:2 - 11
Key Eligibility Criteria
Disqualifiers:Psoriasis, Lupus, Skin Infections, Others
Must Not Be Taking:Corticosteroids, Methotrexate, Cyclosporine, Others
675 Participants Needed
Dupilumab for Asthma
Cincinnati, Ohio
This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to \<6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase.
Study details include:
Part A:
The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period).
Part B:
For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A \[4-week Screening and a 52-week treatment period\] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:2 - 5
Key Eligibility Criteria
Disqualifiers:Severe Asthma, Anaphylaxis, Prematurity, Others
Must Be Taking:Inhaled Corticosteroids
90 Participants Needed
Transcriptomic Skin Analysis for Atopic Dermatitis
Cincinnati, Ohio
This is a multi-center, longitudinal study which will characterize the gene expression profiles and transcriptomic endotypes that underlie mild and moderate-severe Atopic dermatitis (AD) and will determine changes in these expression patterns and endotypes in response to standard-of-care treatment. Participants will complete up to ten scheduled study visits with assessment of topical steroid response and dupilumab response (if uncontrolled with topical steroids). Skin samples will be collected at all study visits to determine the gene expression profiles and transcriptomic endotypes that underlie mild vs. moderate-severe AD disease. The investigators will also evaluate the lipidomic, metabolomic, proteomic, and microbiome profiles of AD skin endotypes associated with mild and moderate-severe AD disease. Non-AD participants will serve as a control population.
The primary objective of this study is to determine if the type 2-high non-lesional skin (skin tape) endotype is associated with current mild versus moderate-severe AD disease.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:HIV, Skin Diseases, Immunosuppression, Others
Must Be Taking:Dupilumab
433 Participants Needed
Dupilumab + ICS/LABA for Asthma
Cincinnati, Ohio
This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication.
The aim of the study is to see which regimen is more effective: taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication. The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist (referred to as an ICS/LABA). Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist (referred to as a LAMA) if they are already receiving a LAMA.
The study is also looking at:
• What side effects may happen from taking dupilumab
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:12 - 80
Key Eligibility Criteria
Disqualifiers:COPD, Lung Diseases, Smoking, Others
Must Be Taking:ICS/LABA
250 Participants Needed
Dupilumab for Preventing Asthma Attacks in Children
Cincinnati, Ohio
This is a multi-center, double-blind, placebo-controlled, randomized trial of dupilumab adjunctive therapy for prevention of asthma exacerbations in urban children and adolescents with T2-high exacerbation-prone asthma.
Stay on current meds
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:6 - 17
Key Eligibility Criteria
Disqualifiers:Pregnancy, Smoking, Cancer, Others
Must Be Taking:Fluticasone, LABA
240 Participants Needed
Dupixent for Itchiness
Akron, Ohio
The goal of this study is to test the efficacy of Dupixent in improving post-burn itching symptoms versus the current standard of care.
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Pregnancy, Cancer, Kidney Disease, Others
Must Not Be Taking:Dupixent, Steroids
46 Participants Needed
Dupilumab for Asthma
Cleveland, Ohio
The Goal of this study is to investigate if individuals ages 12 years and older, carrying the IL-4RαR576 gene variant, will have a greater response to therapy acting directly on the anti-IL-4R. This will be conducted by examining the effect of a 48 week therapy with dupilumab on the rate of asthma exacerbations.
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:12+
Key Eligibility Criteria
Disqualifiers:Chronic Lung Disease, Smoking, Pregnancy, Others
Must Be Taking:Inhaled Corticosteroids, Biologics
150 Participants Needed
Dupilumab for Asthma
Toledo, Ohio
This trial is testing dupilumab, a medication that reduces lung inflammation, in adults with moderate to severe asthma that isn't controlled by usual treatments. It aims to see if dupilumab can help improve breathing and slow down lung damage.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:COPD, Active Infection, Cancer, Others
Must Be Taking:Inhaled Corticosteroids, LABA
1324 Participants Needed
Dupilumab for Esophagitis
Cleveland, Ohio
This is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5 years) to evaluate the effect of dupilumab treatment on esophageal function, and remodeling in adults with eosinophilic esophagitis.
Duration of study period (per participant)
* Screening period: Up to 12 weeks before Week 0
* Randomized double-blind period: 24 weeks
* Open label period: 104 weeks
* Post Investigational Medicinal Product (IMP) intervention follow-up period: up to 12 weeks or until the participants switch to commercialized dupilumab, whatever comes first.
There will be ten (10) site visits, and five (5) direct-to-participant IMP delivery visits (except if prohibited by local regulatory authorities or if participant is not willing. In this case, IMP will be dispensed at the study site).
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Hypereosinophilic Syndrome, Crohn's, Others
Must Not Be Taking:Topical Corticosteroids, Dupilumab
64 Participants Needed
Dupilumab for Itching
Boardman, Ohio
This trial tests a medication that reduces skin inflammation and itching in adults with severe, unexplained itching. It works by blocking proteins that cause these symptoms. The medication has shown promise in treating conditions like atopic dermatitis and asthma.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:HIV, Severe Renal Failure, Others
Must Be Taking:Non-sedative Antihistamines
284 Participants Needed
Dupilumab for Ulcerative Colitis
Poland, Ohio
This trial tests dupilumab, a medication that reduces inflammation, in people with moderate to severe Ulcerative Colitis who have a specific type of immune response. The goal is to see if it can help reduce their symptoms by blocking proteins that cause inflammation.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Severe Colitis, Ileal Pouch, Crohn's, Others
84 Participants Needed
Dupilumab for Chronic Itch
Columbus, Indiana
This is a parallel, Phase 3, 2-arm study for treatment. The purpose of this study is to measure improvement in pruritus with dupilumab subcutaneous injections compared with placebo injections in male and female participants aged at least 18 years with LSC.
Study details include:
The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The follow-up duration after treatment will be 12 weeks. The number of visits will be 6.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Prurigo Nodularis, Atopic Dermatitis, Psoriasis, Others
136 Participants Needed
Dupilumab for Atopic Dermatitis
Ann Arbor, Michigan
Previous research has shown that Asian and African Americans are more likely to develop atopic dermatitis (AD) than their Caucasian counterparts. However, limited information is known about AD in Asian and African American populations because most molecular studies have focused on Caucasians with AD.
This trial will determine differences in inflammatory responses to dupilumab between Caucasian, Asian, and African American patients with AD.
The central hypothesis of this study is that ethnic differences in both immune and stromal cells contribute to variability in AD presentation and response to anti-interleukin-4 receptor (IL-4R) inhibition with dupilumab.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Asthma, COPD, Infections, Cancer, Others
Must Be Taking:Dupilumab
30 Participants Needed
Dupilumab for Asthma
Pittsburgh, Pennsylvania
Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Pregnancy, Smoking, COPD, Cancer, Others
Must Be Taking:Inhaled Corticosteroids
30 Participants Needed
Dupilumab for Chronic Itch
Clarkston, Michigan
This is a parallel, Phase 3, 2-arm study for treatment. The purpose of this study is to measure improvement in pruritus with dupilumab subcutaneous injections compared with placebo injections in male and female participants aged at least 18 years with LSC.
Study details include:
The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The follow-up duration after treatment will be 12 weeks. The number of visits will be 6.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Prurigo Nodularis, Atopic Dermatitis, Psoriasis, Others
136 Participants Needed
Remibrutinib for Chronic Urticaria
Owensboro, Kentucky
This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily \[b.i.d.\] by mouth \[p.o.\]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cardiovascular, Neurological, Psychiatric, Others
Must Be Taking:Second Generation Antihistamines
400 Participants Needed
Dupilumab for Nasal Polyps
Charlottesville, Virginia
Hypothesis: The investigators hypothesize that in patients with CRSwNP who demonstrate sinus colonization with staphylococcus aureus, the administration of dupilumab will be associated with decreased staph colonization and an increase in microbial diversity.
Primary Objective will be to demonstrate that dupilumab reduces staphylococcus aureus (phyla firmicutes) abundance while increasing microbial diversity in patients with CRSwNPs who are culture positive for staph aureus at enrollment.
Secondary Objectives will be to correlate reduction in Staph aureus abundance and improved bacterial diversity with increased expression of anti-microbial proteins (ß-defensins1-4) and cathelicidin LL-37. In addition, the investigators will correlate improvements in microbial diversity/decreased staph abundance with clinical improvements as assessed via questionnaires and objective/subjective smell function and also as improvements in cellular/immune T2 inflammation as assessed by reduced expression of T2 cytokines/chemokines and eosinophil/eosinophil-derived proteins.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Uncontrolled Asthma, Recent Infection, Smoking, Others
Must Be Taking:Dupilumab
20 Participants Needed
Dupilumab for Atopic Dermatitis
Chicago, Illinois
Single center, prospective, Open label study of sleep, pruritus and circadian function pre/post 12-weeks of dupilumab treatment in children 6-17 years old
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:6 - 17
Key Eligibility Criteria
Disqualifiers:Poorly Controlled Asthma, Major Medical Condition, Active Sleep-affecting Condition, Others
Must Be Taking:Inhaled Corticosteroids, Topical Steroids
40 Participants Needed
Why Other Patients Applied
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
Dupilumab for Asthma
Charlottesville, Virginia
Often when people with asthma get a virus caused by the common cold (rhinovirus), they also experience an increase or worsening of their asthma symptoms. The purpose of this study is to see if the study medication dupilumab helps prevent those with mild to moderate asthma from having increased asthma symptoms, after being exposed to an experimental rhinovirus inoculation. This is a study about dupilumab which is a drug approved by the U.S. Food and Drug Administration (FDA) for treatment of moderate to severe asthma. Dupilumab is a medication that blocks pathways that cause asthmatic inflammation in the lungs, leading to symptoms and worsening lung function. During this study, subjects will be given either dupilumab or placebo and will subsequently be exposed to the the "common" cold virus (rhinovirus). The virus that the investigators are using has been safely used before in many studies like this involving thousands of volunteers, and the safe use of the virus in this research study has been reviewed by the FDA. The investigators will track asthma symptoms during the study with lung function tests, questionnaires, specimen collection, biomarkers, and physical exams. For data analysis the investigators will assess the samples collected to determine changes in the treatment groups. The investigators will also asses the symptom scores and deviations from baseline measures for lung function.
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 40
Key Eligibility Criteria
Disqualifiers:Smoking, COPD, Pregnancy, Others
Must Be Taking:Albuterol, Inhaled Corticosteroids
60 Participants Needed
Dupilumab for Alopecia Areata
Chicago, Illinois
This trial tests a new treatment for children and adolescents with significant hair loss due to Alopecia Areata. The treatment likely helps the immune system stop attacking hair follicles, allowing hair to regrow. Oral tofacitinib has shown promising results in treating alopecia areata in children.
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:6 - 17
Key Eligibility Criteria
Disqualifiers:Pregnancy, Severe Asthma, Infections, Others
Must Not Be Taking:Immunosuppressives, Corticosteroids, JAK Inhibitors, Others
76 Participants Needed
Dupilumab for Itchy Skin Diseases
Chicago, Illinois
Severe itch is a common symptom of many genetic skin disorders and leads to a negative impact on patient quality of life. The investigators hypothesize that: a) intervention with dupilumab will improve itch in patients with pruritic genetic inflammatory skin disorders, even those not recognized to be Th2-driven; and b) the administration of dupilumab will be well-tolerated, regardless of underlying genetic skin disorder. The total clinical study duration will be 26 months (104 Weeks). The treatment period will include a 16-week open-label phase and a 20-month long-term extension phase for those who qualify and wish to continue.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:6+
Key Eligibility Criteria
Disqualifiers:Ichthyosis Vulgaris, Active Infections, Malignancies, Others
Must Not Be Taking:Immunosuppressives, Biologics, Retinoids, Others
30 Participants Needed
Dupilumab for Hypereosinophilic Syndrome
Bethesda, Maryland
Background:
Hypereosinophilic syndrome (HES) is a blood disorder that causes high levels of white blood cells called eosinophils. HES can damage the lungs and airways, intestines, skin, and other organs. The current primary treatment for HES can cause serious side effects. Secondary treatments do not work in all people.
Objective:
To test an approved drug (dupilumab), combined with other drugs, in people with HES.
Eligibility:
People aged 18 years and older who take drugs (mepolizumab, reslizumab, or benralizumab) to treat HES.
Design:
Participants will have up to 6 clinic visits and 7 remote visits in up to 48 weeks.
Participants will be screened. They will have blood and urine tests. They will have a test of their heart function. They will take surveys about how HES affects their daily life. Some participants may have a bone marrow biopsy: A sample of tissue and fluid from inside a bone will be removed with a large needle.
Participants will have other tests specific to their symptoms. For example, those with symptoms affecting their lungs will have breathing tests. Others may have tests that target symptoms in their sinuses, gastrointestinal tract, or skin.
Dupilumab is injected under the skin once every 1 or 2 weeks. Dose and timing will vary among participants. They will be taught how to inject themselves at home between clinic visits. They will take dupilumab plus their current medications for 24 weeks. If the drug is helping them, they will continue taking it for another 24 weeks.
Participants will have a final visit 12 weeks after their last dose.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Immunodeficiency, Malignancy, Others
Must Be Taking:Mepolizumab, Reslizumab, Benralizumab
30 Participants Needed
Dupilumab Dosing for Eczema
Baltimore, Maryland
This is a pilot investigator-blinded, randomized clinical trial to assess the feasibility of dupilumab treatment discontinuation or dose-reduction in children aged 1-17 years who have achieved sustained atopic dermatitis (AD) control on dupilumab.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:1 - 17
Key Eligibility Criteria
Disqualifiers:Poor AD Control, Others
Must Be Taking:Dupilumab
30 Participants Needed
Dupilumab for Chronic Sinusitis
Baltimore, Maryland
This trial aims to test the effectiveness of dupilumab, a medication that targets specific immune responses, in treating chronic sinus disease without nasal polyps. The study focuses on patients who have limited treatment options and suffer from long-term sinus issues. Dupilumab works by blocking proteins that cause inflammation, potentially offering a new solution for these patients. Dupilumab is a novel monoclonal antibody that recently received approval for the treatment of chronic rhinosinusitis with nasal polyps.
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Nasal Polyps, Uncontrolled Asthma, Immunodeficiency, Others
Must Not Be Taking:Anti-interleukin, Immunosuppressives, Biologics, Others
50 Participants Needed
Dupilumab for Eosinophilic Esophagitis
Chapel Hill, North Carolina
The purpose of this research study is to determine how well an FDA-approved drug, dupilumab, works to treat patients with severe strictures and active Eosinophilic Esophagitis (EoE). This is an open-label study, meaning everyone in the study will receive dupilumab.
Participants will have a screening visit where they will complete surveys and undergo an endoscopy (EGD). Blood and biopsies (small tissue samples) will also be collected. If eligible and enrolled into the study, participants will receive weekly subcutaneous (under the skin) injections of dupilumab for 52 weeks (one year). The first dose of dupilumab will be administered at the week 1 visit by a clinician and participants will receive training on how to self-administer the remaining doses.
Participants will return for study visits every at weeks 4, 8, 12, 18, 24, 30, 36, 44, and 52. During these visits, vital signs (temperature, heart rate, etc.) will be collected and participants will complete surveys. During visits at week 12, 24, and 52, blood will be collected and an endoscopy with biopsy will be performed.
At 64 weeks (12 weeks after the last dose of dupilumab), participants assigned male at birth (AMAB) will be contacted about their / their partner's pregnancy status and participants assigned female at birth (AFAB) may be asked to come for an in-person visit to complete a urine pregnancy test.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:16+
Key Eligibility Criteria
Disqualifiers:Other Eosinophilic GI Disease, Recent Steroid Use, Recent Live Vaccine, Others
Must Not Be Taking:Biologics, Blood Thinners
30 Participants Needed
Dupilumab for Alopecia Areata
Rochester, New York
This is a prospective, randomized, double blind, placebo-controlled clinical trial. The study will take place at 4 sites. This trial will enroll a total of 68 patients with moderate to severe AA (affecting more than 50% of the scalp) at the time of screening with a targeted 54 subjects completers through Week 48. AA subjects must have evidence of hair regrowth within the last 7 years of their last episode of hair loss; and have screening IgE ≥ 200 and/or have personal and/or familial history of atopy.
Subjects will be randomized (2:1) to either receive weekly dupilumab or placebo for 48 weeks, with all subjects completing participation through Week 48 receiving an additional 48 weeks of dupilumab (through Week 96).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Severe Asthma, Infections, Others
Must Not Be Taking:Immunosuppressives, JAK Inhibitors
68 Participants Needed
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Frequently Asked Questions
How much do clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest clinical trials?
Most recently, we added Remibrutinib for Chronic Urticaria, Dupilumab for Hypereosinophilic Syndrome and Dupilumab for Chronic Itch to the Power online platform.
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