HAL-MPE1 First-in-human

Peanut Allergy Clinical Trial

— HAL-MPE1/0043  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163018
• Other study ID #: HAL-MPE1/0043
• Secondary ID: 2013-004238-13
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2014
• Last updated: July 9, 2015
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: HAL Allergy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 ß-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Drug:
• HAL-MPE1
Subcutaneous administration of increasing doses of HAL-MPE1
• Placebo
Subcutaneous administration of increasing doses of placebo

Locations

Country	Name	City	State
Denmark	Carsten Bindslev-Jensen	Odense

Sponsors (1)

Lead Sponsor	Collaborator
HAL Allergy

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of a SCIT-treatment with HAL-MPE1 in patients with peanut allergy.	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.	up to 20 weeks	Yes
Secondary	Change in serum levels of allergen specific immunoglobulins		before and after 15-20 weeks of treatment	No
Secondary	Change in basophil histamine release test		before and after 15-20 weeks treatment	No
Secondary	Change in titrated skin prick test		before and after 15-20 weeks of treatment	No