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Trial record 9 of 39 for:    Recruiting, Active, not recruiting, Enrolling by invitation Studies | Peanut Allergies

HAL-MPE1 Safety and Tolerability Study

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ClinicalTrials.gov Identifier: NCT02991885
Recruitment Status : Recruiting
First Posted : December 14, 2016
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
HAL Allergy

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.

Condition or disease Intervention/treatment Phase
Peanut Allergy Biological: HAL-MPE1 Drug: HAL-MPE1 placebo Phase 1

Detailed Description:
Currently, there is no effective treatment for peanut allergy other than avoidance of peanut allergens. There is high unmet medical need for a disease modifying treatment for peanut allergy, especially for peanut allergic children, since this age group is at highest risk of peanut-related anaphylaxis requiring hospitalization. A chemically modified, aluminum hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous administration has been developed. The safety and tolerability of HAL-MPE1 have been established in a First-in-human (FIH) study in adults.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multi-centre Study to Assess the Safety, Tolerability and Immunologic Effects of HAL-MPE1 Subcutaneous Immunotherapy in Adult and Paediatric Subjects With Peanut Allergy
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: HAL-MPE1
HAL-MPE1 is an off-white to white liquid suspension containing modified peanut extract
Biological: HAL-MPE1
Weekly subcutaneous administrations of HAL-MPE1
Other Name: Modified peanut extract

Placebo Comparator: HAL-MPE1 placebo
HAL-MPE1 placebo without modified peanut extract
Drug: HAL-MPE1 placebo
Weekly subcutaneous administrations of HAL-MPE1 placebo
Other Name: Placebo for modified peanut extract




Primary Outcome Measures :
  1. Occurrence of local and systemic reactions [ Time Frame: within 30 minutes to >4 hours ]
    Occurrence of immediate (≤ hour), early (1-4) and late (> 4 hours) local and systemic reactions reactions

  2. Occurrence of treatment emergent adverse events [ Time Frame: Troughout study complation, an average 16 weeks ]
    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


Secondary Outcome Measures :
  1. Changes immunoglobulin levels [ Time Frame: Before and after 4, 8 and 16 weeks of treatment ]
    Serum specific and component specific immunoglobulin levels

  2. Changes in basophil activation [ Time Frame: Before and after 16 weeks treatment ]
    In vitro determination of basophil activation upon antigen stimulation

  3. Changes in histamine release test [ Time Frame: Before and after 16 weeks treatment ]
    Determination of histamine release and total cellular histamine content induced by peanut



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Ages Eligible for Study:   5 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 IgE-test (>2.0 kU/L)
  • Skin prick test (SPT) to peanut ≥3 mm compared to negative control within the last 2 years
  • FEV1>80% predicted (adults and adolescents) or 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 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.

Exclusion Criteria:

  • 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, 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
  • Severe (uncontrolled) diseases that could increase the risk for subjects participating in the study, including but not limited to: any severe or unstable lung diseases; endocrine diseases; clinically significant renal or hepatic diseases, renal impairment, haematological disorders; severe ongoing symptomatic allergic diseases
  • History of cardiovascular disease, uncontrolled hypertension or arrhythmias
  • Diseases with a contraindication for the use of epinephrine (e.g. hyperthyroidism, glaucoma)
  • Use of systemic steroids within 4 weeks before start of the study and during the study
  • Treatment with beta-blockers or ACE inhibitors
  • Vaccination within one week before start of therapy or during study unless considered necessary based on the opinion of the investigator.
  • Anti-IgE/anti-TNF/omalizumab therapy or any biologic immunomodulatory therapy within the 6 months prior to inclusion and during the study
  • Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study
  • For female adolescents and adults of childbearing potential: Pregnancy (test performed at screening), lactation or inadequate contraceptive measures for women of child-bearing age (contraceptive measures considered adequate are: intrauterine devices, hormonal contraceptives, such as contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release, sexual abstinence or having no sexual relationship with a man)
  • Alcohol, drug or medication abuse within the past year
  • Any clinically significant abnormal laboratory parameter at screening
  • Lack or expected lack of cooperation or compliance
  • Unable to use the epinephrine pen correctly
  • Severe psychiatric, psychological, or neurological disorders
  • Subjects who are employees of the sponsor, institution or 1st degree relatives or partners of the investigators

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991885


Contacts
Contact: Ioanna Stavrakaki, PharmD +31 (0)88 1959 087 istavrakaki@hal-allergy.com

Locations
United States, Maryland
John Hopkins Hospital University-Divison of Pediatric Allergy Recruiting
Baltimore, Maryland, United States, 21287
Contact: Robert Wood, MD    410-502-3857    rwood@jhmi.edu   
Contact: Kim Mud    410-502-1711    kmudd2@jhmi.edu   
United States, New York
Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Scott Sicherer, MD    212-241-5548    Scott.Sicherer@mssm.edu   
Contact: Jennifer Fisherman, RN, BSN    212-241-7566    Jennifer.Fishman@mssm.edu   
United States, North Carolina
UNC Rheumatolory Allergy & Immunology Clinic Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Edwin Kim, MD    919-966-4095    edwinkim@email.unc.edu   
Contact: Lauren Herlihy       LEKoch@email.unc.edu   
United States, Oklahoma
Allergy, Asthma and Immunology Center Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Iftikhar Hussain, MD       iftikhar.hussain@aaicenter.net   
Contact: Whitney DeNeen    (918) 392-4550    whitney.deneen@aaicenter.net   
United States, Texas
South Texas Allergy & Asthma Medical Professionals (STAAMP) Recruiting
San Antonio, Texas, United States, 78251
Contact: Erika Gonzalez, MD       txallergydoc@gmail.com   
Contact: Carlos Rodriguez    1-210-451-9911    crc@staampallergy.com   
United States, Washington
Asthma, Inc. Recruiting
Seattle, Washington, United States, 98105
Contact: Stephen Tilles, MD       stilles@asthmainc.org   
Contact: Lisa Shelton    +1 206-525-5520    lshelton@asthmainc.org   
Canada, Ontario
Inflamax Research Limited Recruiting
Mississauga, Ontario, Canada, L4W 1A4
Contact: Peter Couroux    (905) 282-1808 ext 2308    pcouroux@inflamaxresearch.com   
Contact: Mahwish Latif    (905) 282-1808    MLatif@inflamaxresearch.com   
Sponsors and Collaborators
HAL Allergy
Investigators
Principal Investigator: 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

Responsible Party: HAL Allergy
ClinicalTrials.gov Identifier: NCT02991885     History of Changes
Other Study ID Numbers: HAL-MPE1/0049
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate