PALISADE Follow-on Study (ARC004)
- Conditions
- Peanut Allergy
- Registration Number
- NCT02993107
- Lead Sponsor
- Aimmune Therapeutics, Inc.
- Brief Summary
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.
- Detailed Description
This is an international, multicenter, open-label, 2-arm follow-on study of the safety, tolerability, and efficacy of AR101 in peanut-allergic individuals who have completed the ARC003 study. This study will explore alternative dosing regimens during extended maintenance with AR101.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 388
- Completion of the ARC003 study
- Written informed consent and/or assent from subjects/guardians as appropriate
- Use of effective birth control by sexually active female subjects of child-bearing potential
Key
- Early discontinuation from the ARC003 study
- Meets any longitudinally applicable ARC003 study exclusion criteria
- (Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 study Exit DBPCFC
- Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) Up to 126 weeks Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall).
- Secondary Outcome Measures
Name Time Method Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) Up to 126 weeks The percentage of subjects who tolerated each the of 300 mg, 600 mg, 1000 mg, or 2000 mg challenge doses with no more than mild symptoms at exit DBPCFC. Analyses based on DBPCFCs used the completer population (age 4-17 years).
Trial Locations
- Locations (64)
Banner University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Allergy & Asthma Associates of Southern California
🇺🇸Mission Viejo, California, United States
Sean N. Parker Center for Allergy Research at Stanford University Packard-El Camino Hospital
🇺🇸Mountain View, California, United States
Peninsula Research Associates, Inc.
🇺🇸Rolling Hills Estates, California, United States
Allergy & Asthma Medical Group and Research Center, APC
🇺🇸San Diego, California, United States
Rady Children's Hospital, San Diego
🇺🇸San Diego, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
UCLA Medical Center, Santa Monica
🇺🇸Santa Monica, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Scroll for more (54 remaining)Banner University of Arizona Medical Center🇺🇸Tucson, Arizona, United States