Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study

Aimmune Therapeutics

Status and phase: Completed; Phase 2

Conditions: Peanut Allergy

Treatments: Biological: AR101 - Peanut protein capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT02198664

ARC002

Details and patient eligibility

About

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.

Full description

This phase 2, open-label, follow-on, multicenter study was designed to gather additional information on the safety, tolerability, and efficacy of oral desensitization with AR101 in subjects who participated in study ARC001 (NCT01987817) as follows:

• Group 1 (ARC001 placebo): Subjects who received placebo in study ARC001
• Group 2 (ARC001 AR101): Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001

All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of Characterized Peanut Allergen (CPNA).

Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may continue Extended Maintenance Phase until CPNA becomes commercially available or the study is terminated.

Enrollment: 47 patients

Sex: All

Ages: 4 to 26 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Completion of ARC001 study
• No change in the status of any longitudinally applicable ARC001 inclusion criteria

Key Exclusion Criteria:

• Early termination from ARC001
• Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge
• A lapse in dosing of more than 10 days from completion of ARC001
• Change in the status of any longitudinally applicable ARC001 exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

47 participants in 2 patient groups

ARC001 placebo group

Experimental group

Description:

Subjects who received placebo in study ARC001.

Treatment:

Biological: AR101 - Peanut protein capsule

ARC001 AR101 group

Experimental group

Description:

Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.

Treatment:

Biological: AR101 - Peanut protein capsule