HAL-MRE1 Subcutaneous Immunotherapy in Ragweed Allergic Patients First-in-human

NCT03758456 | Completed Phase 1 DMC

• 1 other identifier: HAL-MRE1/PR0051
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this first-in-human phase I study is to assess the safety and tolerability of HAL-MRE1 subcutaneous immunotherapy in subjects suffering from ragweed pollen-induced allergic rhinitis/rhinoconjunctivitis with or without asthma. The study has 4 treatment groups: 1 placebo group and 3 groups treated with different doses of HAL-MRE1.

Conditions

Rhinitis, Allergic; Rhinoconjunctivitis, Allergic

Keywords

Subcutaneous immunotherapy; Ragweed pollen; Allergic rhinitis/rhinoconjunctivitis; Safety; Tolerability

Outcome Measures

Primary Outcomes (1)

• Occurence of local and systemic reactions

  Number, intensity and seriousness of early (within 30 mins from injection), delayed (within 30mins and 3 hours from injection) and late (from 3 hours to 24 hours after injection) local reactions (\>8 cm wheal size swelling at injection site) as well as early, delayed and late systemic reactions.

  Through study completion, approximately 10 weeks

Secondary Outcomes (6)

• Occurence of other local reactions

  Through study completion, approximately 10 weeks

• Occurrence of treatment emergent adverse events

  Through study completion, approximately of 10 weeks

• Number of subjects that reach maximum dose

  Through study completion, approximately of 10 weeks

• Number of injections to reach maintenance dose

  Through study completion, approximately of 10 weeks

• Immunoglobulin Levels

  Pre-treatment and after the repeated maintenance dose visit (after 8 to 10 weeks)

Study Arms (4)

HAL-MRE1 0 AUeq

PLACEBO COMPARATOR

15 subjects will receive placebo. Subjects will receive 7-9 incremental weekly injections. All doses will be subcutaneously injected in a double-blind fashion in the upper arm.

Biological: HAL-MRE1

HAL-MRE1 5,000 AUeq

EXPERIMENTAL

10 subjects will receive HAL-MRE1 5,000 AUeq. Subjects will receive 6-8 incremental weekly injections until reaching the maximum dose of 5,000 AUeq. Subsequently, 1 repeated maximum dose injection will be given 1 week later (total treatment period will be approximately 7-9 weeks). All doses will be subcutaneously injected in a double-blind fashion in the upper arm.

Biological: HAL-MRE1

HAL-MRE1 10,000 AUeq

EXPERIMENTAL

10 patients will receive HAL-MRE1 10,000 AUeq. Subjects will receive 6-8 incremental weekly injections until reaching the maximum dose of 10,000 AUeq. Subsequently, 1 repeated maximum dose injection will be given 1 week later (total treatment period will be approximately 7-9 weeks). All doses will be subcutaneously injected in a double-blind fashion in the upper arm.

Biological: HAL-MRE1

HAL-MRE1 20,000 AUeq

EXPERIMENTAL

10 patients will receive HAL-MRE1 20,000 AUeq. Subjects will receive 6-8 incremental weekly injections until reaching the maximum dose of 20,000 AUeq. Subsequently, 1 repeated maximum dose injection will be given 1 week later (total treatment period will be approximately 7-9 year). All doses will be subcutaneously injected in a double-blind fashion in the upper arm.

Biological: HAL-MRE1

Interventions

HAL-MRE1 BIOLOGICAL

HAL-MRE1 is a liquid suspension for subcutaneous administration containing aluminum hydroxide adsorbed modified allergens extracted from ragweed pollen.

HAL-MRE1 0 AUeq; HAL-MRE1 10,000 AUeq; HAL-MRE1 20,000 AUeq; HAL-MRE1 5,000 AUeq

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Male or female subjects aged ≥18 and ≤65 years.
• Documented diagnosis of allergic rhinitis/rhinoconjunctivitis (ARC) to ragweed pollen. A documented diagnosis is a documented medical history of ARC symptoms that required treatment after ragweed pollen exposure. Subjects experienced allergy symptoms that required treatment during the previous 2 ragweed seasons, with or without concomitant asthma (asthma must be controlled).
• Positive nasal provocation test for ragweed pollen at screening or within the last 6 months.
• Positive skin prick test to ragweed allergen at screening or within the last 6 months.
• Positive serum specific IgE test for ragweed allergen (IgE level ≥0.7 U/mL).
• Forced expiratory volume \>70 % or peak expiratory flow \>80 % of predicted value.
• For asthmatic subjects: asthma control test (ACT) score ≥20.
• Subjects are capable and willing to maintain a log of adverse events and concomitant medication throughout the study, as well as to complete a diary 24 hours post investigational medical product injection.
• 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 devices, intrauterine system implants, or vaginal rings (started at least 4 weeks prior to investigational medical product administration).
• double barrier methods e.g. condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent.
• sterilization (male or female).
• participants who are postmenopausal (12 consecutive months without a period) for at least 2 years.

You may not qualify if:

• History of anaphylaxis with cardio respiratory symptoms (food allergy, venom allergy, drugs or/and idiopathic reaction).
• Alcohol, drug or medication abuse in the past.
• Any clinically significant abnormal laboratory parameter at screening as per investigator's discretion.
• Clinically relevant sensitization to other allergens if clinical symptoms are expected during the study.
• Uncontrolled asthma.
• Participation in a clinical interventional study within the last 3 months (e.g. new investigational drug or biological), or plans to participate in another clinical trial during this study, or participation in an observational study (e.g. post marketing study) within the last 30 days unless the observational study aimed to investigate the intradermal test.
• Subjects who received immunotherapy for any specific allergen 3 years prior to screening or during the study period.
• Subjects who were ever treated with any ragweed allergen specific immunotherapy.
• Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs.
• Active malignancies or any malignant disease during the 5 years prior to screening.
• Severe uncontrolled diseases that, in the opinion of the investigator, 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, or hematological disorders; or severe ongoing symptomatic allergic diseases.
• Active or acute inflammation or infection of the target organs (nose, eyes) at screening.
• Diseases with a contra-indication for the use of adrenaline (e.g. hyperthyroidism, glaucoma).
• Lactation.
• Severe psychiatric, psychological, or neurological disorders.

Sponsors & Collaborators

• HAL Allergy: lead

Study Sites (1)

Inflamax Research Inc.

Mississauga, ON L4W 1A4, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Peter Couroux, MD

  Inflamax Research Ltd.

  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 7, 2018
• First Posted: November 29, 2018
• Study Start: November 21, 2018
• Primary Completion: May 17, 2019
• Study Completion: May 17, 2019
• Last Updated: August 6, 2019

Record last verified: 2019-08

Locations

CA (1)