HAL-MPE1 First-in-human (HAL-MPE1/0043)

• ClinicalTrials.gov Identifier: NCT02163018
• Recruitment Status: Completed
• Last Update Posted: July 10, 2015
• Sponsor: HAL Allergy
• Information provided by (Responsible Party): HAL Allergy

Study Description

Brief Summary:

Currently, there is no effective causal treatment for peanut allergy. A chemically modified, aluminium hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous administration has been developed. Results from in vitro and in vivo preclinical studies demonstrate the immunotherapeutic potential of HAL-MPE1. Therefore, a phase I, single-centre clinical trial has been designed to assess the safety and tolerability of HAL-MPE1 in peanut allergic patients.

Condition or disease	Intervention/treatment	Phase
Peanut Allergy	Drug: HAL-MPE1; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A First-in-human, Randomized, Double Blind, Placebo Controlled, Single-centre Study to Assess the Safety and Tolerability of HAL-MPE1 in Patients With Peanut Allergy
• Study Start Date: June 2014
• Actual Primary Completion Date: May 2015
• Actual Study Completion Date: June 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: HAL-MPE1; Subcutaneous administration of increasing doses of HAL-MPE1.	Drug: HAL-MPE1; Subcutaneous administration of increasing doses of HAL-MPE1; Other Name: HAL-MPE1: modified peanut extract
Placebo Comparator: Placebo; Subcutaneous administration of placebo	Drug: Placebo; Subcutaneous administration of increasing doses of placebo; Other Name: HAL-MPE1 placebo

Outcome Measures

Primary Outcome Measures :

1. Safety of a SCIT-treatment with HAL-MPE1 in patients with peanut allergy. [ Time Frame: up to 20 weeks ]
   • Occurrence of early and late local reactions
   • Occurrence of early and late systemic reactions
   • Occurrence of adverse events (clinically relevant abnormalities of the physical examination will be documented as adverse events)
   • Changes in laboratory values, vital signs, ECG and lung function.

Secondary Outcome Measures :

1. Change in serum levels of allergen specific immunoglobulins [ Time Frame: before and after 15-20 weeks of treatment ]
2. Change in basophil histamine release test [ Time Frame: before and after 15-20 weeks treatment ]
3. Change in titrated skin prick test [ Time Frame: before and after 15-20 weeks of treatment ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Signed informed consent.
2. Male or female subjects aged 18-65 years.
3. A well-documented medical history of systemic reactions after ingestion of peanut
4. Positive food challenge at ≤1.5 gram peanut protein ingestion within the last 2 years
5. Positive serum specific anti-peanut and Ara h 2 Immunoglobulin E (IgE-test) (>0.7 kiloUnits(kU)/L) within the last 2 years
6. Forced expiratory volume at one second (FEV1)>70% of predicted value

Exclusion Criteria:

1. Subjects with a history of severe anaphylaxis to peanut with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence) during challenge with peanuts.
2. Baseline serum tryptase level >20 µg/l
3. Known allergy or known hypersensitivity to (placebo) excipients
4. Participation in any interventional study aimed at desensitizing the peanut allergy in the past
5. Any specific immunotherapy (SCIT, SLIT or OIT) during the study period
6. Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
7. Significant active malignancies or any malignant disease within the past 5 years
8. Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: any severe or unstable lung diseases; endocrine diseases; clinically significant renal or hepatic diseases, or haematological disorders; or severe ongoing symptomatic allergic diseases
9. History of cardiovascular disease, uncontrolled hypertension or arrhythmias
10. Diseases with a contraindication for the use of adrenaline (e.g. hyperthyroidism, glaucoma)
11. Use of systemic steroids within 4 weeks before start of the study and during the study
12. Treatment with β-blockers/ACE inhibitors
13. Vaccination within one week before start of therapy or during study
14. Anti-IgE/anti-Tumor necrosis factor (TNF) therapy or any biologic immunomodulatory therapy within the 6 months prior to inclusion and during the study
15. 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
16. 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)
17. Alcohol, drug or medication abuse within the past year
18. Any clinically significant abnormal laboratory parameter at screening
19. Lack or expected lack of cooperation or compliance
20. Severe psychiatric, psychological, or neurological disorders
21. Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigators

Contacts and Locations

Locations

Denmark

Carsten Bindslev-Jensen

Odense, Denmark, DK 5000

Sponsors and Collaborators

HAL Allergy

Investigators

• Principal Investigator: Carsten Bindslev-Jensen, Prof. Dr.; Hudafdeling I og Allergicentret, Odense Universitetshospital

More Information

• Responsible Party: HAL Allergy
• ClinicalTrials.gov Identifier: NCT02163018
• Other Study ID Numbers: HAL-MPE1/0043; 2013-004238-13 ( EudraCT Number )
• First Posted: June 13, 2014
• Last Update Posted: July 10, 2015
• Last Verified: July 2015

Additional relevant MeSH terms:

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