Health TrialsbyHealthPanel

Efficacy of Tezepelumab in Peanut Oral Immunotherapy

ConditionPeanut Allergy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-55
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

The proposed study is a proof-of-concept Phase 2, double-blind, randomized placebo-controlled clinical trial evaluating the safety and efficacy of tezepelumab and peanut Oral Immunotherapy (OIT) for the treatment of peanut allergy. Study participation is divided into 3 periods: (i) a monotherapy period comprised of injections of either Tezepelumab or placebo from week 0 to week 8, (ii) followed by a combination therapy period comprised of 56 weeks during which peanut OIT is built up and maintained, and (iii) a treatment withdrawal period comprised of 12 weeks. This study will enroll 62 peanut-allergic individuals from 12 to 55 years of age who experience dose-limiting symptoms to \<=100 mg of peanut protein in a single dose (\<= 144 mg cumulative dose) as assessed by DBPCFC.

The primary objective is to determine whether 56 weeks of tezepelumab plus peanut OIT as compared to 56 weeks of placebo plus peanut OIT induces sustained unresponsiveness to peanut 12 weeks after stopping combination therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant and/or parent/legal guardian must be able to understand and provide informed consent (parental permission and informed assent of minor, if applicable).

Age 12 to 55 years inclusive with a personal history of an allergic reaction to peanut ingestion

A positive reaction at or below ingestion of 100 mg of peanut protein in a single dose (≤ 144 mg cumulative dose) during the Screening DBPCFC

A negative challenge to the placebo (oat) during the Screening DBPCFC

Disqualifiers

Currently in build-up phase of aeroallergen immunotherapy

Current food allergen immunotherapy or use of any food allergen immunotherapy within the past 12 months

Pregnant, planning a pregnancy during the study, or breast-feeding

History of intolerance, hypersensitivity, or allergic reactions to tezepelumab, or the inactive ingredients (excipients) of tezepelumab, other IgG biologics, or rescue medications and their excipients

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tezepelumab

    Biological/Vaccine

    Monotherapy Period: Participants randomized to tezepelumab will receive two subcutaneous (SQ) injections of tezepelumab 210 mg during the monotherapy period. Combination Therapy Period: Participants randomized to Tezepelumab will continue to receive Tezepelumab 210 mg every 4 weeks. Withdrawal Period: Participants will stop receiving Tezepelumab injections.

  • Peanut Oral Immunotherapy (OIT)

    Drug

    Monotherapy Period: Not Applicable. Combination Therapy Period: During combination therapy period, each participant will start peanut OIT. Participants will start on a minimum of 0.1 mg peanut OIT, with starting dose depending on last tolerated dose from screening double-blind placebo-controlled food challenge (DBPCFC) and build to a maximum of 6 mg peanut OIT on the initial dose escalation (IDE) day. Participants will return every 2 weeks for dose escalation to a goal maintenance dose of 2000 mg peanut protein. Withdrawal Period: Participants will stop peanut OIT.

  • Placebo for Tezepelumab

    Biological/Vaccine

    Monotherapy Period: Participants randomized to placebo for tezepelumab will receive two subcutaneous (SQ) injections of placebo 210 mg during the monotherapy period. Combination Therapy Period: Participants randomized to placebo will continue to receive placebo for Tezepelumab every 4 weeks. Withdrawal Period: Participants will stop receiving placebo injections.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Tezepelumab plus Peanut Oral Immunotherapy (OIT) GroupExperimental treatment 2 interventions
Group B: Placebo for Tezepelumab plus peanut Oral Immunotherapy (OIT) GroupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Consumption of a cumulative dose of 4000 mg of peanut protein without dose-limiting symptoms during the open Oral Food Challenge (OFC)

The primary endpoint is sustained unresponsiveness to peanut 12 weeks after stopping combination therapy, as assessed by passing the open OFC to peanut at Week 76

Time frame
At week 76

Secondary outcomes

1

Highest single dose of peanut protein consumed without doselimiting symptoms during the open Oral Food Challenge (OFC)

Time frame
At week 64 and 76
2

Consumption of a cumulative dose of 4000 mg of peanut protein without doselimiting symptoms during the open Oral Food Challenge (OFC)

Time frame
At week 64
3

Highest cumulative dose of peanut protein consumed without dose limiting symptoms during the open Oral Food Challenge (OFC)

Time frame
At week 64 and 76
4

An adverse event related to monotherapy

Time frame
During 8 weeks of therapy

Other outcomes

Sponsors and contacts

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National Institute of Allergy and Infectious Diseases (NIAID)

Lead sponsor

Immune Tolerance Network (ITN)

Collaborator

PPD Development, LP

Collaborator

Rho Federal Systems Division, Inc.

Collaborator

Source ClinicalTrials.gov
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