FARE - Food Allergy Research & Education Logo

Efficacy of Tezepelumab in Peanut Oral Immunotherapy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years - 55 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Participant and/or parent/legal guardian must be able to understand and provide informed consent (parental permission and informed assent of minor, if applicable) 2. A personal history of an allergic reaction to peanut ingestion. 3. A positive reaction at or below ingestion of 100 mg of peanut protein in a single dose (<= 144 milligram cumulative dose) during the screening Double-Blind Placebo-Controlled Food Challenge (DBPCFC) 4. A negative challenge to the placebo (oat) during the Screening DBPCFC. 5. Sensitization to peanut as evidenced by either one of the following: 1. positive sIgE to Ara h2 >= 0.35 kilounit per liter by ImmunoCAP (TM) testing, or. 2. wheal >= 3 mm on skin prick test to peanut extract compared to a negative control. 6. Female participants of childbearing potential must have a negative pregnancy test upon study entry. 7. Female participants with reproductive potential must agree to use an FDA approved method of contraception for the duration of the study. 8. Willing and able to comply with the study protocol requirements. 9. Participants with other food allergies must agree to continue avoidance of these food items from their diet to avoid confounding the safety and efficacy data of the study.

Exclusion Criteria:

1. Currently in build-up phase of aeroallergen immunotherapy. 2. Current food allergen immunotherapy or use of any food allergen immunotherapy within the past 12 months. 3. Pregnant, planning a pregnancy during the study, or breast-feeding. 4. 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. 5. Allergy to oat (participant reported) 6. History of severe systemic allergic reaction to peanut with symptoms including the need for mechanical ventilation and/or severe hypotension requiring intensive care unit admission. 7. Asthma requiring high dose inhaled corticosteroid therapy for control (2007 NHLBI Criteria Steps 5 or 6 in adults and adolescents) 8. History of a life-threatening asthma attack within 1 year before screening (e.g., requiring an ICU admission or intubation with mechanical ventilation), need for oral corticosteroids for asthma management within the last 6 months, or current Asthma Control Test score less than 19 at screening. 9. History of ischemic cardiovascular disease or other cardiac disease, where, in the opinion of the site investigator, participation in the trial would pose a risk from participation in the study. 10. History of eosinophilic gastrointestinal disease at screening. 11. History of disease affecting the immune system such as autoimmune disease (e.g., systemic lupus erythematosus), immune complex disease (e.g., serum sickness), or immunodeficiency, where, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. 12. History of malignancy of any type, excluding basal cell and squamous cell cancers of the skin that only required surgical excision or in situ carcinoma of the cervix study provided that curative therapy was completed at least 12 months prior to informed consent. 13. Current known helminth infection. 14. Positive QuantiFERON
  • - TB Gold test or TB Gold Plus, or T-SPOT(R) TB test unless the potential participant has been treated with appropriate chemoprophylaxis.
In the case of an indeterminate or borderline Interferon Gamma Release Assay (IGRA), an IGRA may be repeated. 15. Any of the following: 1. HIV. 2. current or prior infection with hepatitis B virus (HBV) 3. current or prior infection with hepatitis C virus (HCV), except adequately treated HCV with sustained virologic response >= 12 weeks. 16. Active liver disease, defined as either: 1. AST, ALT, and/or Alk phos >2x ULN, or. 2. other active liver disease which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. 17. Any of the following: 1. Current use of beta-blockers, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers. 2. Received any investigational product within the past 4 months or 5 half-lives (whichever is longer) prior to screening. 3. Received systemic corticosteroids within 14 days prior to screening. 4. Receipt of immunoglobulin or other blood product within 30 days of screening. 5. Receipt of live attenuated vaccine within 30 days of informed consent. 6. Use of an immunosuppressant or immunomodulating drug within 30 days prior to screening. 7. Use of biologics targeting the human immune system within the past 12 months prior to screening. 8. Use of any herbal medications, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. 18. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07015996
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Edwin H Kim, M.D., M.S.Sarita Patil, M.D.
Principal Investigator Affiliation North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and RheumatologyMassachusetts General Hospital: Department of Medicine: Allergy & Clinical Immunology Unit
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIH, Other, Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Peanut Allergy
Study Website: View Trial Website
Arms & Interventions

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.

Interventions

Biological: - Tezepelumab

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.

Drug: - Peanut Oral Immunotherapy (OIT)

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.

Biological: - Placebo for Tezepelumab

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Little Rock 4119403, Arkansas 4099753

Status

Address

Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology

Little Rock 4119403, Arkansas 4099753, 72202

Los Angeles 5368361, California 5332921

Status

Address

University of California, Los Angeles: Department of Medicine, Division of Clinical Immunology and Allergy

Los Angeles 5368361, California 5332921, 90095

Baltimore 4347778, Maryland 4361885

Status

Address

Johns Hopkins Children's Center: Department of Allergy & Immunology

Baltimore 4347778, Maryland 4361885, 21287

Boston 4930956, Massachusetts 6254926

Status

Address

Massachusetts General Hospital: Department of Medicine: Allergy & Clinical Immunology Unit

Boston 4930956, Massachusetts 6254926, 02114

Boston 4930956, Massachusetts 6254926

Status

Address

Boston Children's Hospital: Allergy and Asthma Program

Boston 4930956, Massachusetts 6254926, 02115

Ann Arbor 4984247, Michigan 5001836

Status

Address

The University of Michigan: Division of Allergy and Clinical Immunology

Ann Arbor 4984247, Michigan 5001836, 48105

New York 5128581, New York 5128638

Status

Address

Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology

New York 5128581, New York 5128638, 10029-6574

Chapel Hill 4460162, North Carolina 4482348

Status

Address

North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology

Chapel Hill 4460162, North Carolina 4482348, 27599

Cincinnati 4508722, Ohio 5165418

Status

Address

Cincinnati Children's Hospital Medical Center: Division of Allergy and Immunology

Cincinnati 4508722, Ohio 5165418, 45229

Dallas 4684888, Texas 4736286

Status

Address

University of Texas Southwestern Medical Center: Division of Allergy and Immunology

Dallas 4684888, Texas 4736286, 75390-9063

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.