Clinical trials: Peanut Allergy
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.
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
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
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
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
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
Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy
The objectives of this dose-finding study for the treatment of peanut allergy are: To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg peanut protein per patch) to significantly desensitize…
- Trial name
- VIPES (NCT01675882)
- Testing
- Viaskin Peanut 50 mcg, Viaskin Peanut 100 mcg, Viaskin Peanut 250 mcg
- Where
- 24 sites in United States, Canada and 3 more
- Volunteers
- 221 people
- Sponsor
- DBV Technologies
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
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
Viaskin® Peanut (DBV712) Expanded Access Protocol
This is an open label expanded access program for male and female patients ≥ 4 years old.
- Trial name
- NCT04371627
- Testing
- Viaskin Peanut
- Sponsor
- DBV Technologies
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
Peanut Allergy
HAL-MPE1 Safety and Tolerability Study
The aim of this study is to confirm safety and tolerability of incremental doses of HAL-MPE1 subcutaneous immunotherapy (SCIT) in peanut allergic adults, and subsequently assess the safety and tolerability in adolescents and…
- Trial name
- NCT02991885
- Testing
- HAL-MPE1
- Where
- 7 sites in United States, Canada
- Volunteers
- 42 people
- Sponsor
- HAL Allergy
Peanut Allergy
A Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects
The study aims to assess the biological potency of the In-House Reference Preparation (IHRP) of peanut allergens extract by a quantitative Skin Prick Test (SPT) method in peanut-allergic subjects.
- Trial name
- V712-103 (NCT03352726)
- Testing
- DBV712 IHRP
- Where
- 2 sites in United States
- Volunteers
- 27 people
- Sponsor
- DBV Technologies
Peanut Allergy
HAL-MPE1 First-in-human
Currently, there is no effective causal treatment for peanut allergy. A chemically modified, aluminium hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous administration has been developed.
- Trial name
- HAL-MPE1/0043 (NCT02163018)
- Testing
- HAL-MPE1
- Where
- Denmark
- Volunteers
- 17 people
- Sponsor
- HAL Allergy
Peanut Allergy
Efficacy and Safety of 4 Doses of QGE031 in Patients 18-50 Years of Age With Peanut Allergy
This study will assess the clinical potency of several exposure levels of QGE031 in decreasing the sensitivity against peanut allergen.
- Trial name
- NCT01451450
- Testing
- QGE031
- Sponsor
- Novartis Pharmaceuticals
Peanut Allergy
Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy
The purpose of this phase 1b study is to evaluate the safety and tolerability of repeated epicutaneous applications of peanut proteins using a patch delivery system (Viaskin device) in peanut allergic subjects.
- Trial name
- NCT01170286
- Testing
- Whole peanut extract
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- DBV Technologies