Clinical trials: Nut Allergy in Children
Peanut Allergy
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT
This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.
- Trial name
- ARC001 (NCT01987817)
- Testing
- AR101 powder provided in capsules
- Where
- 8 sites in United States
- Volunteers
- 56 people
- Sponsor
- Aimmune Therapeutics, Inc.
Peanut Allergy
PALISADE Follow-on Study (ARC004)
The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed the ARC003 study.
- Trial name
- NCT02993107
- Testing
- AR101
- Where
- 65 sites in United States, Canada and 7 more
- Volunteers
- 388 people
- Sponsor
- Aimmune Therapeutics, Inc.
Peanut Allergy
Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children
This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active…
- Trial name
- PEOPLE (NCT03013517)
- Testing
- Viaskin Peanut 250µg
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 300 people
- Sponsor
- DBV Technologies
Allergy, Peanut
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind…
- Trial name
- VITESSE (NCT05741476)
- Testing
- DBV712
- Where
- 87 sites in United States, Australia and 7 more
- Volunteers
- 600 people
- Sponsor
- DBV Technologies
Peanut Allergy
Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children
The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are: To assess the efficacy of Viaskin Peanut after up to 36…
- Trial name
- OLFUS-VIPES (NCT01955109)
- Testing
- Viaskin Peanut 250 mcg
- Where
- 22 sites in United States, Canada and 2 more
- Volunteers
- 171 people
- Sponsor
- DBV Technologies
Peanut Allergy
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).
- Trial name
- EPITOPE (NCT03211247)
- Testing
- Part A Viaskin Peanut 250 mcg, Part A Viaskin Peanut 100 mcg, Part B Viaskin Peanut 250 mcg
- Where
- 51 sites in United States, Australia and 6 more
- Volunteers
- 414 people
- Sponsor
- DBV Technologies
Allergy, Peanut Allergy
Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.
- Trial name
- NCT07003919
- Testing
- DBV712 250 mcg
- Where
- 91 sites in United States, Australia and 6 more
- Volunteers
- 480 people
- Sponsor
- DBV Technologies
Peanut Allergy
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101 using the characterized oral desensitization immunotherapy (CODIT™) regimen in peanut-allergic children.
- Trial name
- RAMSES (NCT03126227)
- Testing
- AR101
- Where
- 67 sites in United States, Canada
- Volunteers
- 506 people
- Sponsor
- Aimmune Therapeutics, Inc.
Peanut Allergy
Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study
This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.
- Trial name
- NCT02198664
- Testing
- AR101 - Peanut protein capsule
- Where
- 8 sites in United States
- Volunteers
- 47 people
- Sponsor
- Aimmune Therapeutics, Inc.
Peanut Allergy
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.
- Trial name
- PALISADE (NCT02635776)
- Testing
- AR101 powder provided in capsules & sachets
- Where
- 69 sites in United States, Canada and 8 more
- Volunteers
- 555 people
- Sponsor
- Aimmune Therapeutics, Inc.
Food Allergy
Open-label Extension Study of ADP101
This is an open-label, safety extension study for participants who participated in the Harmony study (protocol ADP101-MA-01).
- Trial name
- NCT05243719
- Testing
- ADP101
- Where
- 14 sites in United States
- Volunteers
- 45 people
- Sponsor
- Alladapt Immunotherapeutics, Inc.
Food Allergy
ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.
- Trial name
- NCT04856865
- Testing
- Low dose ADP101, High dose ADP101
- Where
- 15 sites in United States
- Volunteers
- 73 people
- Sponsor
- Alladapt Immunotherapeutics, Inc.
Peanut Allergy
Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children
Open-label, follow-up study for subjects who completed the EPITOPE study.
- Trial name
- EPOPEX (NCT03859700)
- Testing
- DBV712 250 mcg
- Where
- 26 sites in United States
- Volunteers
- 304 people
- Sponsor
- DBV Technologies
Peanut Allergy
Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy
This clinical research study investigates the safety, tolerability and efficacy of a peanut SLIT-tablet in adults, adolescents, and children with peanut allergy.
- Trial name
- NCT05440643
- Testing
- Peanut SLIT-tablet
- Where
- 42 sites in United States, Canada
- Volunteers
- 209 people
- Sponsor
- ALK-Abelló A/S
Peanut Allergy
Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents
To compare the HRQOL of AR101 characterized oral desensitization immunotherapy (CODIT™) in combination with standard of care (peanut avoidance, education) versus standard of care alone in peanut-allergic subjects aged 4 to 17…
- Trial name
- NCT03703791
- Testing
- AR101
- Where
- 11 sites in Spain
- Volunteers
- 1 people
- Sponsor
- Aimmune Therapeutics, Inc.
Peanut Allergy
AR101 Real-World Open-Label Extension Study
This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.
- Trial name
- NCT03337542
- Testing
- AR101
- Where
- 60 sites in United States, Canada
- Volunteers
- 243 people
- Sponsor
- Aimmune Therapeutics, Inc.
Peanut Allergy
ARTEMIS Peanut Allergy In Children
The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral immunotherapy (OIT) in peanut-allergic children.
- Trial name
- ARTEMIS (NCT03201003)
- Testing
- AR101 powder provided in capsules & sachets
- Where
- 18 sites in France, Germany and 5 more
- Volunteers
- 175 people
- Sponsor
- Aimmune Therapeutics, Inc.
Peanut Allergy
Safety Study of Viaskin Peanut to Treat Peanut Allergy
This study evaluates the safety of Viaskin Peanut 250 µg in the treatment of peanut allergy in children from 4 to 11 years of age.
- Trial name
- REALISE (NCT02916446)
- Testing
- Viaskin Peanut 250 µg
- Where
- 32 sites in United States, Canada
- Volunteers
- 393 people
- Sponsor
- DBV Technologies
Peanut Allergy, Peanut Hypersensitivity
A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
The overall aims of this study are to demonstrate that treatment with PVX108 immunotherapy has an acceptable safety profile and is effective for reducing clinical reactivity to peanut protein in children and adolescents with…
- Conditions
- Peanut Allergy, Peanut Hypersensitivity, Peanut-Induced Anaphylaxis, Immune System Diseases
- Trial name
- NCT05621317
- Testing
- PVX-108
- Where
- 14 sites in United States, Australia
- Volunteers
- 95 people
- Sponsor
- Aravax Pty Ltd
Peanut Allergy
Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy
The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age after a 12-month treatment by epicutaneous…
- Trial name
- PEPITES (NCT02636699)
- Testing
- Viaskin Peanut 250mcg
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 500 people
- Sponsor
- DBV Technologies