EUCTR2016-004941-94-SEActive, not recruitingPhase 1
PEANUT ALLERGY ORAL IMMUNOTHERAPY STUDY OF AR101 FOR DESENSITIZATION IN CHILDREN AND ADULTS (PALISADE) FOLLOW-ON STUDY - PALISADE Follow-on Study
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Aimmune Therapeutics, Inc.
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •1. Completion of ARC003
- •2. Written informed consent and/or assent from subjects/guardians as appropriate
- •3. Use of effective birth control by female subjects of child-bearing potential
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 400
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Early discontinuation from ARC003
- •2. Meets any longitudinally applicable ARC003 exclusion criteria
- •3. Failure to tolerate =443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 Exit DBPCFC (Group 2 only)
- •4. Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
Investigators
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