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CLINICAL RESEARCH - Asthma Allergy

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Upcoming Studies

Below please find the list of our upcoming Studies:

AV003 / The MANDALA Study - A long-term, randomized, double-blind, multicenter, parallel-group, phase III study evaluating the efficacy and safety of PT027 compared to PT007 administered as needed in response to symptoms in symptomatic adults and children 4 years of age or older with asthma (Mandala) / AV003

Study Medication Study Major Inc / Criteria Sponsor Study Title
Budesonide/Albuterol metered dose inhaler Asthma •Age 4 years old and above
• Diagnosis of Asthma for at least 1 year
• Receiving asthma maintenance therapies
• History of at least 1 severe asthma exacerbation within the last 12 months		 Avillion A long-term, randomized, double-blind, multicenter, parallel-group, phase III study evaluating the efficacy and safety of PT027 compared to PT007 administered as needed in response to symptoms in symptomatic adults and children 4 years of age or older with asthma (Mandala) / AV003

D3250R00023 / The CHRONICLE Study - A Longitudinal Prospective Observational Study of the Characteristics, Treatment Patterns and Health Outcomes of Individuals with Severe Asthma in the United States

Study Study Major Inc / Criteria Sponsor Study Title
Asthma – Observational study Asthma • Age 18 years old and above
• Diagnosis of severe asthma for at least 1 year
• Currently receiving care from specialist physicians (eg, pulmonologists and/or allergists) at the Investigator’s or sub-investigator’s site
• Uncontrolled asthma despite receiving high-dose ICS with additional controllers, or use FDA-approved monoclonal antibodies or systemic corticosteroids or other systemic immunosuppressants for the treatment of severe asthma		 AstraZeneca A Longitudinal Prospective Observational Study of the Characteristics, Treatment Patterns and Health Outcomes of Individuals with Severe Asthma in the United States.

B7451036 A phase 3, randomized, double blind, placebo-controlled, multi-center study investigating the efficacy and safety of PF 04965842 co-administered with background medicated topical therapy in adolescent participants 12 to <18 years of age with moderate-to-severe atopic dermatitis (B7451036)

Study Medication Study Major Inc / Criteria Sponsor Study Title
PF 04965842, a JAK kinase inhibitor oral tablet Atopic Dermatitis / Eczema • Age 12 to <18 years old
• Have a diagnosis of chronic atopic dermatitis for at least 1 year
• Have symptoms of moderate to severe AD when you enter the study
• Have not responded to topical medications or needed systemic therapy to control their AD		 Pfizer A phase III, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two dose levels of BCX7353 as an oral treatment for the prevention of attacks in subjects with hereditary angioedema.

BCX7353-204 An open-label study to evaluate the long-term safety of daily oral BCX7353 in subjects with type I and II hereditary angioedema

Study Medication Study Major Inc / Criteria Sponsor Study
BCX7353, an oral tablet Hereditary Angioedema (HAE) • Age 12 years old and above
• Have been diagnosed with HAE Type 1 or 2
• Have access to and take their own prescribed on-demand acute attack medications (either at home or in a medical setting)		 BioCryst An open-label study to evaluate the long-term safety of daily oral BCX7353 in subjects with type I and II hereditary angioedema

SHP643-301 / The SPRING Study An Open-Label, Multicenter, Phase 3 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab for Prevention Against Acute Attacks of Hereditary Angioedema (HAE) in Pediatric Subjects 2 to <12 Years of Age

Study Name Study Medication Major Inc / Criteria Sponsor Study Title
Hereditary Angioedema (HAE) – pediatric prophylactic treatment Takhzyro (Lanadelumab), anti-plasma kallikrein monoclonal antibody injection • Age between 2 and < 12 years old at the time of study enrollment
• Have a confirmed diagnosis of Hereditary Angioedema type I or II
• Have at least one HAE attack per three months		 Takeda / Shire An Open-Label, Multicenter, Phase 3 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab for Prevention Against Acute Attacks of Hereditary Angioedema (HAE) in Pediatric Subjects 2 to <12 Years of Age

CSL312_2001 A multicenter, randomized, placebo-controlled, parallel-arm study to investigate the efficacy, pharmacokinetics and safety of CSL312 in subjects with hereditary angioedema

Study Name Study Medication Major Inc / Criteria Sponsor Study Title
Hereditary Angioedema (HAE) – acute treatment CSL312, Factor XIIa antagonist monoclonal antibody injection CSL Behring LLC The CHRONICLE Study: A Longitudinal Prospective Observational Study of the Characteristics, treatment patterns and Health Outcomes of Individuals with Severe Asthma in the United States.

SHP643-403 / The EMPOWER study An observational, non-interventional, study of patients with hereditary angioedema in the United States and Canada (EMPOWER study)

Study Name Study Medication Major Inc / Criteria Sponsor Study Title
Hereditary Angioedema (HAE) – observational study • Diagnosis of HAE Type I or Type II
• Ability to use a mobile device for data collection in the study		 Takeda / Shire the EMPOWER study
An observational, non-interventional, study of patients with hereditary angioedema in the United States and Canada (EMPOWER study)

SAIRB-18-0006 Genetic profiling for patients with hereditary angioedema

Study Name Study Medication Major Inc / Criteria Sponsor Study Title
Hereditary Angioedema (HAE) • Age 2 years old and above
• Confirmed or suspected to have HAE		 CSL Behring LLC SAIRB-18-0006
Genetic profiling for patients with hereditary angioedema

Peanut allergy: the role of microbiota. A comparison between the oral and fecal microbiome profile in peanut allergic children and age matched healthy controls

Study Name Study Medication Major Inc / Criteria Sponsor Study Title
Peanut Allergy – Investigator Initiated Study • Age between 6 months to 17 years old
• Peanut allergic subjects or healthy controls		 CSL Behring LLC