A Study to Evaluate the Safety and Effectiveness of Dupilumab and Milk Oral Immunotherapy to Treat Patients with Cow's Milk Allergy

Overview

About this study

The purpose of this study is to assess whether dupilumab as an adjunct to milk oral immunotherapy (OIT) compared to placebo improves desensitization and safety, defined as an increase in the proportion of subjects who pass a double-blind placebocontrolled food challenge (DBPCFC) to at least 2040 mg cumulative milk protein at week 18.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age 4 to 50 years (inclusive).
  • Subject has a clinical history of allergy to cow’s milk or milk-containing foods.
  • Experience clinical reaction at or before 444 mg cumulative protein dose of cow’s milk protein on Screening DBPCFC.
  • No clinical reaction observed during the placebo (oat) Screening DBPCFC.
  • Serum IgE to milk of > 4 kUA/L within the last 12 months and/or a SPT to milk ≥ 6 mm compared to a negative control.
  • Subjects/Caregivers must be trained on the proper use of the epinephrine auto-injector device to be allowed to enroll in the study.
  • Subjects with other known food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study.
  • Written informed consent from parent/guardian for minor subjects.
  • Written assent from minor subjects as appropriate (e.g., at and above the age of 7 years or the applicable age per local regulatory requirements).
  • For women of childbearing potential, must agree to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods (barrier methods or oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy) during the treatment period and for 60 days after the last dose of study drug.

Exclusion Criteria:

  • Any previous exposure to dupilumab.
  • Known hypersensitivity to dupilumab or any of its excipients.
  • Known hypersensitivity to epinephrine or any of its excipients.
  • Allergy to oat (placebo in DBPCFC).
  • History of severe anaphylaxis to cow’s milk, defined as neurological compromise or requiring intubation.
  • Recent history of frequent severe, life-threatening episodes of anaphylaxis or anaphylactic shock as defined as 3 or more episodes of anaphylaxis within the past year.
  • Inability to tolerate biological (antibody) therapies.
  • Body weight ≤ 17 kg at the time of screening.
  • History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia (e.g., difficulty swallowing, food “getting stuck”), or recurrent gastrointestinal symptoms of undiagnosed etiology.
  • History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension.
  • History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, and hereditary angioedema.
  • Established diagnosis of a primary immunodeficiency disorder (e.g., Severe Combined Immunodeficiency, Wiskott Aldrich Syndrome, DiGeorge Syndrome, X-linked Agammaglobulinemia, Common Variable Immunodeficiency), or secondary immunodeficiency.
  • Severe asthma (Global Initiative for Asthma, 2020: Personalized management to control symptoms and minimize future risk requiring treatment Steps 4 or 5; Appendix 1).
  • Mild or moderate asthma (Global Initiative for Asthma, 2020:
    • Personalized management to control symptoms and minimize future risk requiring treatment Steps 1-3; Appendix 1), if uncontrolled or difficult to control.
    • Uncontrolled asthma as evidenced by:
      • Forced expiratory volume in 1 second (FEV1) <80% of predicted, or ratio of FEV1 to forced vital capacity (FEV1/FVC) <75% of predicted, with or without controller medications (only for age 7 or greater and able to do spirometry); OR
      • One overnight admission to a hospital in the past year for asthma; OR
      • Emergency room (ER) visit for asthma within six months prior to screening.
  • Current participation or within the last 4 months in any other interventional study.
  • Use of omalizumab within 6 months prior to screening.
  • In build up phase of immunotherapy for aeroallergens or venom.
  • Use of other investigational drugs or allergen immunotherapy (e.g., oral, subcutaneous (SC), patch or sublingual) or immunomodulatory therapy (not including corticosteroids) within 4 months of participation.
  • Reciept of live vaccine within 2 weeks prior to Study Week 0 or unable to comply with recommendation against receiving live vaccine during study
  • Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers.
  • Use of oral antihistamines (within five half lives), beta-agonists (within 12 hours), theophylline (within 12 hours), and cromolyn (within 12 hours) prior to Screening DBPCFCs or SPTs.
  • Pregnant or breastfeeding women, women planning to become pregnant or breastfeed during the study.
  • Girls at or beyond menarche who are not sexually abstinent and are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 60 days after the last dose. Highly effective contraceptive measures include stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening; intrauterine device (IUD); intrauterine hormone releasing system (IUS); bilateral tubal ligation; vasectomized partner; and or sexual abstinence.
  • Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
  • Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and the lactational amenorrhoea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Benjamin Wright, M.D.

Open for enrollment

Contact information:

Temeka Simmons

(480) 301-9224

Simmons.Temeka@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20531158

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