HAL-MPE1 Safety and Tolerability Study

NCT02991885 | Completed Phase 1 DMC

• 1 other identifier: HAL-MPE1/0049
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 7

Brief Summary

The aim of this study is to confirm safety and tolerability of incremental doses of HAL-MPE1 subcutaneous immunotherapy (SCIT) in peanut allergic adults, and subsequently assess the safety and tolerability in adolescents and children with peanut allergy.

Conditions

Peanut Allergy

Outcome Measures

Primary Outcomes (2)

• Occurrence of local and systemic reactions

  Occurrence of immediate (≤ hour), early (1-4) and late (\> 4 hours) local and systemic reactions reactions

  within 30 minutes to >4 hours

• Occurrence of treatment emergent adverse events

  Treatment emergent adverse events will be collected by reporting of adverse events and by clinical relevant changes in laboratory values, vital signs, lung function and aluminum levels in plasma and urine

  Throughout study completion, an average 16 weeks

Secondary Outcomes (3)

• Changes immunoglobulin levels

  Before and after 4, 8 and 16 weeks of treatment

• Changes in basophil activation

  Before and after 16 weeks treatment

• Changes in histamine release test

  Before and after 16 weeks treatment

Study Arms (2)

HAL-MPE1

EXPERIMENTAL

HAL-MPE1 is an off-white to white liquid suspension containing modified peanut extract

Biological: HAL-MPE1

HAL-MPE1 placebo

PLACEBO COMPARATOR

HAL-MPE1 placebo without modified peanut extract

Drug: HAL-MPE1 placebo

Interventions

HAL-MPE1 BIOLOGICAL

Weekly subcutaneous administrations of HAL-MPE1

Also known as: Modified peanut extract

HAL-MPE1

HAL-MPE1 placebo DRUG

Weekly subcutaneous administrations of HAL-MPE1 placebo

Also known as: Placebo for modified peanut extract

HAL-MPE1 placebo

Eligibility Criteria

• Age: 5 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Signed informed consent/assent
• Male or female subjects aged 5- 50 years
• A well-documented medical history of systemic reactions after ingestion of peanut
• Positive serum specific anti-peanut (\>5.0 kU/L) and Ara h 2 Immunoglobulin E (IgE)-test (\>2.0 kU/L)
• Skin prick test (SPT) to peanut ≥3 mm compared to negative control within the last 2 years
• Forced expiratory volume at first second (FEV1)\>80% predicted (adults and adolescents) or Peak expiratory flow(PEF)\>80% predicted (children)
• Negative pregnancy test at screening for females of childbearing potential
• Females of childbearing age must be using an effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study. Contraceptive measures considered adequate are:
• hormonal contraceptives such as contraceptive pills, transdermal patches, intrauterine device (IUD), intrauterine system (IUS) implant, or vaginal ring (started - least 4 weeks prior to Investigational Medicinal Product (IMP) administration)
• double barrier methods: e.g. condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent
• surgical sterilization of the female participant (removal of the uterus or ovaries or tubal ligation)
• participants who are postmenopausal (12 consecutive months without a period) for at least 2 years
• male partner sterilization (vasectomy with documentation of azoospermia) prior to the female patient's entry into trial and is the sole sexual partner for that female patient
• sexual abstinence or having no sexual relationship with a man.

You may not qualify if:

• Subjects with a history of severe anaphylaxis to peanut with the following symptoms: hypotension, neurological compromise (collapse, loss of consciousness or incontinence) after ingestion of peanuts
• Baseline serum tryptase level \>20 µg/l
• Known allergy or hypersensitivity to an excipient in the study drug or placebo
• Clinical features of moderate or severe persistent asthma (as guided by the 2007 NHLBI Guidelines and according to the opinion of the investigator)
• Asthma with FEV1\<80% predicted (adults, adolescents) or PEF \<80% predicted (children)
• Asthma Control Test (ACT) ≤ 19
• Asthma attack/exacerbation within the last 3 months
• Hospitalization due to asthma within the last year
• Two or more courses of oral steroids within the last 6 months
• History of intubation /mechanical ventilation due to allergies or asthma
• Participation in any interventional study with peanut immunotherapy in the last year
• Any specific immunotherapy (SCIT, Sublingual Immunotherapy (SLIT) or OIT) during the study period
• Severe immune disorders (including autoimmune diseases) and/or diseases requiring immunosuppressive drugs
• Presence of chronic urticaria, atopic dermatitis with flare or atopic dermatitis with SCORAD\>40
• Active malignancies or any malignant disease within the past 5 years

Sponsors & Collaborators

• HAL Allergy: lead

Study Sites (7)

John Hopkins Hospital University-Divison of Pediatric Allergy

Baltimore, Maryland, 21287, United States

Location

Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

UNC Rheumatolory Allergy & Immunology Clinic

Chapel Hill, North Carolina, 27517, United States

Location

Allergy, Asthma and Immunology Center

Tulsa, Oklahoma, 74136, United States

Location

South Texas Allergy & Asthma Medical Professionals (STAAMP)

San Antonio, Texas, 78251, United States

Location

Asthma, Inc.

Seattle, Washington, 98105, United States

Location

Inflamax Research Limited

Mississauga, Ontario, L4W 1A4, Canada

Location

Related Publications (1)

• Reyes AJ, Hosein AS, Ramcharan K, Perot S. Anaphylaxis and other allergic reactions to food: a global challenge. BMJ Case Rep. 2020 May 14;13(5):e231425. doi: 10.1136/bcr-2019-231425.

  PMID: 32414772 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Robert Wood, MD

  John Hopkins Hospital Unversity-Divison of Pediatric Allergy

  PRINCIPAL INVESTIGATOR

• Scott Sicherer, MD

  Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Edwin Kim, MD

  UNC Rheumatolory Allergy & Immunology Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: December 14, 2016
• Study Start: December 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: September 1, 2019
• Last Updated: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (6)