RFA-AI-22-054 Research Studies to be Supported by the AA-SCCC

Network

Study Title

NCT #

IND Y/N

Health Authority

# of sites

# of participants

Status

ADRN

Longitudinal Endotyping of Atopic Dermatitis Through Transcriptomic Skin Analysis (LEADS - ADRN12) 

pending

N

FDA IND exempt

9

600

In startup; to be initiated in Q3 2022; expected duration 3 years

ADRN

A Pilot Study to Evaluate the Survival of Transplanted Staphylococcus hominis A9 on the Skin of Adults with Moderate-to-Severe Atopic Dermatitis

NCT05177328

Y

FDA

1

20

In startup; to be initiated in Q2 2022; expected duration 1 year

CoFAR

Systems Biology in Early Atopy birth cohort (SUNBEAM - CoFAR12)

NCT04798079

N

FDA IND Exempt

12

2500

Ongoing; recruitment to be completed by Q1 2024; study to be completed by Q4 2027

CoFAR

Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children (OUTMATCH - CoFAR11)

NCT03881696

Y

FDA

10

165

Ongoing; enrollment to be completed by Q3 2022, study to be completed by Q4 2025

ICAC/CAUSE

Cockroach Immunotherapy in Inner City Asthma (CRITICAL- ICAC28)

NCT03541187

Y

FDA

11

80

Ongoing, fully enrolled; study to be completed by June 2022; not all analyses may be completed by AA-SCCC initiation

ICAC/CAUSE

Urban Environment and Childhood Asthma birth cohort (URECA - ICAC07)

NCT00114881

N

FDA IND Exempt

4

440

Ongoing, fully enrolled; to be completed by Q4 2024

ICAC/CAUSE

Mechanisms Underlying Asthma Exacerbations Prevented and Persistent with Immune-Based Therapy: A Systems Approach Phase 2 (MUPPITS 2 - ICAC30)

NCT03292588

Y

FDA

9

290   

Study completed; some publications pending

CAUSE

Prevention of Asthma Exacerbations Using Dupilumab in Urban Children, and Adolescents
(PANDA - CAUSE01)

NCT05347771

N

FDA IND exempt

7

240

In startup; to be initiated in Q2 2022; expected duration 3 years

CAUSE

Registry of Asthma Characterization and Recruitment 3 (RACR3 – CAUSE02)

NCT05272241

N

FDA Exempt

7

1500

Ongoing; expected duration 6 years

CAUSE

Mechanisms Underlying Asthma Symptoms and Exacerbations Examined Across T2 Status in Children (CHEETAH – CAUSE03 )

pending

pending

FDA expected to be IND exempt

7

250

In startup; to be initiated in Q4 2022; expected duration 3 years

ITN

Anti-TSLP (MEDI9929/AMG157) plus Antigen-Specific Immunotherapy for the Induction of Tolerance in individuals with cat allergy (CATNIP - ITN057AD)

NCT02237196

Y

FDA

9

120

Study completed; publications pending

ITN

Follow up of LEAP Participants and Their Families (LEAP TRIO – ITN070AD)

NCT03546413

N

MHRA Exempt

1

1800

Ongoing; recruitment/study to be completed by Q3 2022

ITN

 A Randomized, Double-blind, Single-center, Placebo-controlled Study of Antigen-specific Sublingual immunotherapy plus Dupilumab for Induction of Tolerance in Adults with Seasonal Allergic Rhinitis (GRADUATE – ITN084AD)

NCT04502966

CTA (UK)

MHRA (UK)

1

105

Ongoing, fully enrolled; study to be completed by Q2 2025

ITN

Exposure to Vaginal Microbiome in C-section Infants at High-Risk for Allergies (ACTIVATE - ITN079AD)

NCT03567707

Y

FDA

2

95

Ongoing; enrollment to be completed by Q2 2023; study to be completed by Q4 2026

ITN

Efficacy of Tezepelumab in Peanut Oral Immunotherapy: A Double-Blind, Randomized, Placebo-Controlled Trial (ZENITH – ITN097AD)

pending

Y

FDA

15

128

In startup; to be initiated in Q1 2023; expected duration 4 years