Efficacy of Tezepelumab in Peanut Oral Immunotherapy

Conditions

• Peanut Allergy

Eligibility Criteria

Sex

ALL

Age

12 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Tezepelumab — BIOLOGICAL
  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
  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.

Study Details

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.

Key Dates

First listed

Jun 11, 2025

Start date

Jul 15, 2026

Status verified

Jun 2026

Primary completion

Sep 16, 2028

Completion

Sep 16, 2028

Study Design

Enrollment

62 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tezepelumab plus Peanut Oral Immunotherapy (OIT) Group
  Eligible participants will be randomized in a 1:1 fashion to receive Tezepelumab during the monotherapy period of the trial. Throughout the combination therapy period, which also includes an OIT build-up and maintenance period, participants will remain on tezepelumab 210 mg every 4 weeks until reaching the final period of the trial, the withdrawal period.
• Placebo Comparator: Placebo for Tezepelumab plus peanut Oral Immunotherapy (OIT) Group
  Eligible participants will be randomized in a 1:1 fashion to receive placebo for Tezepelumab during the monotherapy period of the trial. Throughout the combination therapy period, which also includes an OIT build-up and maintenance period, participants will remain on placebo for tezepelumab every 4 weeks until reaching the final period of the trial, the withdrawal period.

Primary Outcome Measure

Consumption of a cumulative dose of 4000 mg of peanut protein without dose-limiting symptoms during the open Oral Food Challenge (OFC) [ Time Frame: At week 76 ]

Locations (10)

Find similar trials in Little Rock, AR

Related Studies

• VE416 for Treatment of Food Allergy
  PHASE1/PHASE2 · Recruiting · Massachusetts General Hospital · Boston, Massachusetts
• Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients
  PHASE2 · Recruiting · Rima Rachid · Boston, Massachusetts
• Safety of MOON101 for the Treatment of Peanut Allergy
  PHASE1 · Recruiting · Moonlight Therapeutics, Inc. · Little Rock, Arkansas
• Study of ENP-501 in Peanut-Allergic and Non-Allergic Participants
  PHASE1/PHASE2 · Recruiting · N-Fold, LLC · Aurora, Colorado