Welcome to the ACAAI Clinical Trial Resources
While the ACAAI does not endorse these trials, we do encourage clinicians and their patients to partake in this valuable resource. Without these clinical trials, medical advancements would be greatly hindered.
Trial Opportunities
To obtain information on how to participate in a clinical trial, please browse the trial opportunities below.
Remibrutinib in Adolescents with CSU
Company: Novartis
Clinical Trial Title: A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years
Clinical Trial Description: The purpose of this trial is:
- to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to < 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines
- to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment
- to collect safety data in this population for up to three years after the last dose of study treatment
Eligible Patients: Adolescents, aged 12-17 years
Learn more about this clinical trial: Clinical Trials.gov
Remibrutinibin CINDU
Company: Novartis
Clinical Trial Title: A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled, Basket Study With an Open-label Extension to Investigate the Efficacy, Safety, and Tolerability of Remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in Adults Inadequately Controlled by H1-antihistamines
Clinical Trial Description: The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs). The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period.
Eligible Patients: Adult patients with cold urticaria or cholinergic urticaria for > 4 months.
Learn more about this clinical trial: ClinicalTrials.gov.
The ACADIA Study
Company: AstraZeneca
Date posted to ClinicalTrials.gov: March 13, 2024
Clinical Trial Title: A Randomized, Double-blind, Multicenter, Parallel Group, Phase 3b, 52 Week Study Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma (ACADIA)
Clinical Trial Description: The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI; PT027) with albuterol sulfate metered-dose inhaler (AS MDI; PT007), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents. The study plans to enroll a total of 440 participants, where the estimated study duration of each participant will be approximately 58 weeks: a screening period of 1-4 weeks, a treatment period of 12 months and a follow-up period of 1-2 weeks. The study will also include an optional pharmacokinetic sub-study, with a single visit scheduled after the safety follow-up visit in the main study.
Eligible Patients: Adolescents, aged 12-17 years old with documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.
Learn more about this clinical trial: AZ Clinical Trials and ClinicalTrials.gov.
AERIFY 2
Company: Sanofi and Regeneron
Date posted to CT.gov: February 12, 2021
Clinical Trial Title: Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (AERIFY-2)
Clinical Trial Description: Sanofi and Regeneron are researching if an investigational medicine plus certain controller therapies could potentially lessen COPD symptoms and improve breathing and overall well-being in former smokers (>10 packs year) who are between 40 and 85 years old with moderate-to-severe COPD. This global, multi-center, phase 3 clinical trial (AERIFY 2) is a randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/ REGN3500/ Itepekimab (Anti-IL-33 mAb) in former smokers with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). The study expects to enroll 1,210 participants across 254 sites.
Eligible Patients: Former smokers, ages 40-85, with moderate-to-severe COPD
Contacts: Sanofi Trial Transparency, 800-633-1610, option 6, Contact-US@sanofi.com
Learn more about this clinical trial: Sanofi Studies or ClinicalTrials.gov.
AERIFY 3
Company: Sanofi and Regeneron
Date posted to CT.gov: October 28, 2021
Clinical Trial Title: A Phase 2 Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients with COPD (AERIFY-3)
Clinical Trial Description: Treatments for chronic obstructive pulmonary disease (COPD) may still leave you looking for relief from wheezing, coughing, and shortness of breath. That’s why Sanofi and Regeneron are researching the mechanism of action of an investigational medicine in former and current smokers who are between 40 and 70 years old with COPD.
This phase 2a clinical trial (AERIFY 3) is an exploratory, two-part, 12-week study to evaluate the mechanism of action of itepekimab (Anti-IL-33 mAb) and its impact on airway inflammation. This study consists of participants who have been on a standard-of-care (SoC) mono (long-acting β2-agonist [LABA]) or long-acting muscarinic antagonist [LAMA]), double (inhaled corticosteroid [ICS] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants will stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD). The study expects to enroll 60 participants.
Eligible Patients: Former and current smokers, between 40-70 years old, with COPD.
Contacts: Sanofi Trial Transparency, 800-633-1610, option 6, Contact-US@sanofi.com
Learn more about this clinical trial Sanofi Studies or ClinicalTrials.gov.
ATLAS
Company: Sanofi and Regeneron
Clinical Trial Title: A Phase 3b/4 Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma
Clinical Trial Description: Sanofi and Regeneron are studying the long-term effect of dupliumab on the prevention of lung function decline in adult patients with uncontrolled moderate to severe asthma. This Phase 3b/4 study (ATLAS), is an interventional, randomized, parallel group, treatment, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma.
The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.
The study expects to enroll approximately 1860 participants across 168 study sites worldwide.
Eligible Patients: Adults, between 18-65, with asthma
Contacts: Sanofi Trial Transparency, 800-633-1610, option 6, Contact-US@sanofi.com
Learn more about this clinical trial: Sanofi Studies or ClinicalTrials.gov
MORPHEO
Company: Sanofi and Regeneron
Date posted to CT.gov: August 6, 2020
Clinical Trial Title: A Phase 4, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients with Uncontrolled Persistent Asthma
Clinical Trial Description: Sanofi and Regeneron are studying the effect of dupliumab on sleep in adults ages 18-65 with asthma, who are currently using a medium to high dose inhaled corticosteroid (ICS) and a second controller.
Study duration per participant will be approximately 16 weeks and up to 29 weeks including up to 5 weeks screening period, a 12-week treatment period and up to 12 weeks post-treatment follow-up period or until the participant switches to commercialized dupilumab (or other biologic product), whichever comes first.
The study expects to enroll approximately 260 participants across 59 study sites worldwide.
Eligible Patients: Adults, ages 18-65, with asthma
Contacts: Sanofi Trial Transparency, 800-633-1610, option 6, Contact-US@sanofi.com
Learn more about this clinical trial Sanofi Studies or ClinicalTrials.gov.
EVEREST
Company: Sanofi and Regeneron
Date posted to CT.gov: August 10, 2021
Clinical Trial Title: A Phase 4 Randomized, Double-blind, Head-to-head Comparison of Dupilumab Versus Omalizumab in Severe Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Comorbid Asthma Patients
Clinical Trial Description: Sanofi and Regeneron are studying the efficacy of dupilumab compared to omalizumab in reducing size of nasal polyps and improving sense of smell in patients with chronic rhinosinusitis with nasal polyps and comorbid asthma.
Study duration per participant will be 38 weeks. The study will comprise 3 periods: 28 days ± 3 days screening and run-in period; 24 weeks Randomized investigational medicinal product (IMP) intervention period; up to 12 weeks follow-up period.
The study expects to enroll approximately 260 participants across 59 study sites worldwide.
Eligible Patients: Adults, ages 18-65, with CRSwNP and comorbid asthma
Contacts: Sanofi Trial Transparency, 800-633-1610, option 6, Contact-US@sanofi.com
Learn more about this clinical trial Sanofi Studies or ClinicalTrials.gov.
LIBERTY-CSU-CUPID
Company: Sanofi and Regeneron
Date posted to CT.gov: November 27, 2019
Clinical Trial Title: A Phase 3 Study of Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)
Clinical Trial Description: Sanofi and Regeneron are studying the efficacy of dupilumab in individuals ages 6-80 with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite the use of H1 antihistamine (non-drowsy oral antihistamines). There are 3 randomized, double-blind, placebo controlled, multi-center, parallel-group studies under one master protocol. Study A & C: omalizumab naïve; Study B: omalizumab intolerant or incomplete responders. The study will measure the impact on weekly itch severity score.
The duration of study for each participant will include 2-4 weeks of screening period, 24 weeks of treatment period and 12 weeks of post treatment period. Participants must be willing and able to complete a daily symptom e-Diary for the duration of the study.
The study expects to enroll approximately 384 participants across 79 study sites worldwide.
Eligible Patients: Patients ages 6-80 with CSU who remain symptomatic despite the use of non-drowsy oral antihistamines
Contacts: Sanofi Trial Transparency, 800-633-1610, option 6, Contact-US@sanofi.com
Learn more about this clinical trial Sanofi Studies or ClinicalTrials.gov.
LIBERTY-AFRS-AI
Company: Sanofi and Regeneron
Date posted to CT.gov: December 24, 2020
Clinical Trial Title: A Phase 3 Randomized Double-blind Placebo-controlled Parallel Group Study Assessing the Efficacy and Safety of Dupilumab in Patients with Allergic Fungal Rhinosinusitis (AFRS)
Clinical Trial Description: Sanofi and Regeneron are studying the efficacy of dupilumab in reducing sinus opacification in individuals 6 years and older with Allergic Fungal Rhinosinusitis (AFRS). Additional exploratory endpoints are included.
This randomized, double-blind, placebo-controlled study will include 2-4 weeks of screening period (2 additional weeks could be allowed), 52 weeks of randomized investigational medicinal product (IMP) intervention period and 12 weeks of follow-up period.
The study expects to enroll approximately 62 participants across 45 study sites worldwide.
Eligible Patients: Patients ages 6 and older who have AFRS.
Contacts: Sanofi Trial Transparency, 800-633-1610, option 6, Contact-US@sanofi.com
Learn more about this clinical trial Sanofi Studies or ClinicalTrials.gov.
LIBERTY-CPUO-CHIC
Company: Sanofi and Regeneron
Date posted to CT.gov: March 22, 2022
Clinical Trial Title: A Phase 3 Study of the Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)
Clinical Trial Description: Sanofi and Regeneron are studying the efficacy of dupilumab in adult patients with Chronic Pruitus of Unknown Origin (CPUO). The main objective of this Phase 3 study is to assess efficacy and safety of dupilumab when given up to 24 weeks in adults with CPUO.
This is a master protocol which includes 2 parallel-treatment, double-blind, 2- arm Phase 3 staggered studies of similar design (Study A and Study B) in male and female participants aged 18 to 90 years with CPUO. Study B design may be adapted based on the results of Study A.
For both Study A and B, after an up-to-4-week screening period, participants with severe pruritus (worst-itch numerical rating scale [WI-NRS ≥7) will enter a 4-week run-in period during with a non-sedative antihistamine and an emollient (moisturizer). Participants with severe pruritus (WI-NRS ≥7) at baseline will be randomized (1:1) to be treated for 24 weeks (Study A) or 12 weeks (Study B) with either dupilumab or matching placebo in addition to their antihistamine and emollient regimen. The treatment period for both study A and B will be followed by a 12-week follow-up period.
The study plans to enroll 208 participants from 50 sites worldwide. The study duration per participant will be 44 weeks for Study A and 32 weeks for Study B.
Eligible Patients: Male and female patients aged 18 to 90 years with CPUO
Contacts: Sanofi Trial Transparency, 800-633-1610, option 6, Contact-US@sanofi.com
Learn more about this clinical trial Sanofi Studies or ClinicalTrials.gov.
LIBERTY-CSU/CINDU CUPIDKids
Company: Sanofi and Regeneron
Date posted to CT.gov: September 2, 2022
Clinical Trial Title: A Phase 3 Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants >=2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) or Chronic Inducible Cold Urticaria (CICU) (LIBERTY-CSU/CINDU CUPIDKids)
Clinical Trial Description: Sanofi and Regeneron are studying the efficacy of dupilumab in children with Chronic Spontaneous Urticaria or Chronic Inducible Cold Urticaria in a multicenter, single-arm, 24-week treatment, Phase 3 PKM16982 study.
The purpose of this study is to investigate the Pharmacokinetics (PK) and safety of dupilumab in children diagnosed with CSU or CICU who remain symptomatic despite the use of H1-antihistamine treatment and/or appropriate preventive measures.
Participants will undergo a screening period of 2-4 weeks, a treatment duration of 24 weeks, and a follow-up period of 12 weeks. The total study duration, inclusive of screening and follow-up, is 38-40 weeks. There are 8 study visits.
The study plans to enroll 24 participants from 4 study sites in the US and Canada.
Eligible Patients: Male and female patients between 2-11 years old, with Chronic Spontaneous Urticaria or Chronic Inducible Cold Urticaria
Contacts: Sanofi Trial Transparency, 800-633-1610, option 6, Contact-US@sanofi.com
Learn more about this clinical trial Sanofi Studies or ClinicalTrials.gov.
LOU064 Food allergy study
Novartis
A study of a month-long treatment to examine the efficacy and safety of remibrutinib (LOU064), a BTK inhibitor, in patients with peanut allergy. The primary endpoint is evaluated by the ability to tolerate 600 mg of peanut protein. Participating sites are open in the USA, Spain and Italy.
Eligible patients – Adults aged 18-55 with IgE-mediated peanut allergy.
For more information, see clinicaltrials.gov and Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
SUPERNOVA Trial for AZD3152
AZD3152 is a next-generation long-acting antibody combination being developed to protect and treat vulnerable patients such as the immunocompromised from COVID-19.
If you’ve got a weakened immune system, the threat of the COVID-19 virus is still present. We’re researching a trial drug that could help protect you against new strains of SARS-CoV-2 (the virus that causes COVID-19, which you may know as coronavirus).
Learn more at the SUPERNOVA clinical trial website.
Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Genentech, Inc.; Novartis Pharmaceuticals
This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 1 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab.
Selected key inclusion criteria:
- Age 1-55 years, with signed informed consent and/or assent
- Allergic to peanut and at least 2 of the following foods based on DBPCFC: milk, egg, wheat, cashew, hazelnut, walnut
- Eligibility for omalizumab dosing, according to the study drug-dosing table
Selected key exclusion criteria:
- Dose-limiting symptoms to the placebo portion of the screening DBPCFC
- Sensitivity or suspected/known allergy to omalizumab
- Poorly controlled atopic dermatitis at screening
- Poorly controlled or severe asthma/wheezing at screening
- History of severe anaphylaxis to participant-specific foods used in this study
