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Clinical Trial Resources

Welcome to the ACAAI Clinical Trial Resource page which connects physicians to existing clinical trials in allergy, asthma and immunology led by our pharmaceutical partners. Involvement in clinical trials provides the opportunity to further medical research and improve patient outcomes. 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.

To obtain information on how to become involved in a clinical trial, please browse the trial opportunities below.

The following trials listed are from the ACAAI Corporate Council Benefactor Members. If you are not a participating member, but would like to list your trial, please contact Linda Cullison at lindacullison@acaai.org.

Clinical Trials​

VITESSE

Company: DBV Technologies

Date posted to CT.gov: February 23, 2023

Clinical Trial Title: A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy With DBV712 250 µg in 4-7 year old Children With Peanut Allergy (VITESSE)

Clinical Trial Description: The primary purpose of this study is to assess the efficacy and safety of daily ViaskinTM Peanut 250 µg (DBV712 250 µg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month treatment period. This is a global study with sites in the US, Canada, the EU, and Australia, which plans to enroll 600 participants. The estimated study duration for each participant will be approximately 58 weeks: Screening Period of 4 weeks, Treatment Period of 12 months and Follow-up Period of 2 weeks.

Participant eligibility will be assessed by peanut skin prick test (SPT), serum peanut immunoglobulin-E (IgE), and eliciting dose upon peanut double-blind placebo-controlled food challenge (DBPCFC). Randomization of eligible participants will occur in a 2:1 ratio to Viaskin Peanut (active treatment) or placebo, respectively.

Eligible Patients: Children 4-7 years old with peanut allergy with an eliciting dose to peanut of ≤ 100 mg.

Learn more about this clinical trial: VitesseAllergyStudy.com or 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

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

See Trial Information

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