PALISADE Follow-on Study (ARC004)

Aimmune Therapeutics

Status and phase: Completed; Phase 3

Conditions: Peanut Allergy

Treatments: Biological: AR101

Study type: Interventional

Funder types: Industry

Identifiers

NCT02993107

ARC004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 388 patients

Sex: All

Ages: 4 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 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 Exclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

388 participants in 2 patient groups

Group 1 (Placebo Crossovers)

Other group

Description:

Subjects who complete the placebo arm of ARC003 and consent to enroll in ARC004 (Group-1) will cross over to active treatment with AR101 using the same dosing regimen used in ARC003 in open-label fashion. Group 1 subjects may also be assigned to cohorts which test the gradual lengthening of dosing intervals. Following the completion of their longest tested dosing interval, Group 1 subjects will undergo an exit double-blinded placebo-controlled food challenge (DBPCFC).

Treatment:

Biological: AR101

Group 2 (Active Rollovers)

Other group

Description:

Subjects who successfully complete the active arm of ARC003 and consent to enroll in ARC004 (Group-2) will consecutively enter treatment with AR101 in one of three cohorts which will test alternate dosing intervals. There will be a DBPCFC at the completion of the subject's longest tested dosing interval.

Treatment:

Biological: AR101