Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants

Summary

This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 1 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab.

Conditions

• Peanut Allergy
• Multi-food Allergy

Interventions

DRUG

Omalizumab

Omalizumab will be supplied in pre-filled syringes (PFS). PFS of omalizumab will be provided to the clinical research units as 75 mg and 150 mg dosage forms.

DRUG

Placebo for Omalizumab

Placebo contains the same ingredients as the omalizumab formulation, excluding omalizumab. Placebo will be supplied in pre-filled syringes (PFS). PFS of placebo will be provided to the clinical research units as 75 mg and 150 mg dosage forms.

DRUG

Multi-Allergen Oral Immunotherapy

Multi-allergen OIT will be any of the following drug products: peanut, milk, egg, wheat, cashew, hazelnut, and walnut (all food protein flours). A prescription for each participant for the appropriate dose of each of the allergens will be prepared. The pharmacist will compound the appropriate allergens and dispense the Multi-allergen OIT dose in a blinded (masked) fashion. The Clinical Research Unit (CRU) staff will administer food flour to the participant orally in an age-appropriate food vehicle (e.g., applesauce, pudding, etc.). Dosage will be administered according to the study protocol.

DRUG

Placebo for Multi-Allergen Oral Immunotherapy

Oat flour will be used for placebo for Multi-allergen OIT. Route: by mouth/oral. Dosage will be administered according to the study protocol.

OTHER

Double-Blind Placebo-Controlled Food Challenge Based Treatment

Each participant will receive a separate treatment plan for peanut and each of the two other participant-specific foods. A treatment plan will include instructions for one of the following: * Long-term follow-up with dietary consumption of a food; or * Long-term follow-up with avoidance of a food; or * Rescue OIT for a food. The treatment plan for each food may change depending on a participant's response to prescribed treatment over time.

Sponsors & Collaborators

• Genentech, Inc.

  collaborator INDUSTRY

• Novartis Pharmaceuticals

  collaborator INDUSTRY

• Rho Federal Systems Division, Inc.

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Robert A. Wood, MD · Department of Pediatrics at the Johns Hopkins University School of Medicine

• Sharon Chinthrajah, MD · Department of Medicine, Stanford University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

1 Year

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-22

Primary Completion

2023-03-13

Completion

2025-07-01

FDA Drug

Yes

Countries

• United States

Study Locations