Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03736447|
Recruitment Status : Active, not recruiting
First Posted : November 9, 2018
Last Update Posted : August 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Peanut Allergy||Biological: AR101 powder Biological: Placebo powder||Phase 3|
|Study Type :||Interventional|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||2:1 randomization|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON)|
|Actual Study Start Date :||December 27, 2018|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
Active Comparator: AR101 powder (Peanut allergen formulation)
Subjects will be randomized to active arm of ARC005 and will be administered IP (AR101) in escalating doses for approximately 6 months.
Biological: AR101 powder
AR101 powder provided in capsules and sachets (peanut allergen formulation)
Placebo Comparator: Placebo powder
Subjects will be randomized to placebo arm of ARC005 and will be administered escalating doses of IP (placebo) for approximately 6 months.
Biological: Placebo powder
Placebo powder provided in capsules and sachets
- Efficacy of AR101 [ Time Frame: 12 months ]The proportion of subjects treated with AR101 compared with placebo who tolerate an at least 600 mg single dose (for patients in the US) or 1000 mg single dose (for patients in Europe) of peanut protein with no more than mild allergy symptoms during the exit double-blind placebo-controlled food challenge (DBPCFC).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736447
|Study Director:||Freddy Byrth||Aimmune Therapeutics|