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.
ACT18421 Study
Company: Sanofi and Regeneron
Date posted to CT.gov: November 15, 2024
Clinical Trial Title: A Randomized, Double-blind, Placebo-controlled, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of Itepekimab in Participants With Inadequately Controlled Chronic Rhinosinusitis Without Nasal Polyps
Clinical Trial Description: ACT18421 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo in male and female participants with chronic rhinosinusitis without nasal polyps (CRSsNP) aged 18 years of age and older.
Study details include:
- The study duration (4-week screening, 24–week intervention, 20–week safety follow-up) will be 48 weeks.
- The intervention duration will be 24 weeks.
- The number of visits will be 7 site visits and 8 phone/remote visits.
Eligible patients: 18 years of age and older
Contacts:
- Trial Transparency email recommended (Toll free for US & Canada
- Phone Number: 800-633-1610, ext option 6
- Email: contact-us@sanofi.com
Learn more about this Clinical Trial: Sanofi Studies or 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.
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
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.
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
