A Study of Tolerability and Safety of a New Cumulative Dose of Grass MATA MPL

NCT03931993 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: GrassMATAMPL104
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration. Previously, high cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) were compared with the marketed dose of 5100 SU and were found to have acceptable tolerability and safety. The purpose of this study is to evaluate the tolerability and safety of an even higher cumulative dose regimen of 35600 SU. of Grass MATA MPL compared with placebo in patients with seasonal allergic rhinoconjunctivitis (SAR) due to grass pollen, to enable selection of the best dose to take forward for further development.

Conditions

Seasonal Allergic Rhinitis

Keywords

Grass MATA MPL; Safety

Outcome Measures

Primary Outcomes (11)

• Number and frequency of adverse events (AEs)

  36 - 48 days

• Number and frequency of adverse reaction complexes (ARCs)

  The maximum intensity of all injection site \[local\] and systemic AEs experienced by a patient within a 24-hour period after an injection.

  36 - 48 days

• Frequency of premature discontinuation from treatment or study due to AEs.

  36 - 48 days

• Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Systolic blood pressure

  Mean values compared to normal range

  30 - 40 days

• Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Diastolic blood pressure

  Mean values compared to normal range

  30 - 40 days

• Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Pulse

  Mean values compared to normal range

  30 - 40 days

• Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Body temperature

  Mean values compared to normal range

  30 - 40 days

• Changes in routine clinical laboratory values - Serum Chemistry

  Absolute and relative number of patients with values below, within or above the normal range

  36 - 48 days

• Changes in routine clinical laboratory values - Hematology

  Absolute and relative number of patients with values below, within or above the normal range

  36 - 48 days

• Changes in routine clinical laboratory values - Urinalysis

  Absolute and relative number of patients with values below, within or above the normal range

  36 - 48 days

• Changes in peak expiratory flow rate (PEFR) before and after injections in asthmatic patients

  30 - 40 days

Secondary Outcomes (2)

• Number and frequency of neuro-inflammatory (NI) events.

  36 - 48 days

• Number and frequency of new onset autoimmune disease (NOAD) events.

  36 - 48 days

Other Outcomes (1)

• Transcriptomics analysis

  36-48 days

Study Arms (2)

Treatment Group 1

PLACEBO COMPARATOR

Six 1.0mL placebo injections (2% w/v L-tyrosine)

Biological: Placebo comparator

Treatment Group 2

EXPERIMENTAL

Six 1.0mL injections of Grass MATA MPL 900, 2700, 8000, 8000, 8000, and 8000 SU

Biological: Grass MATA MPL

Interventions

Placebo comparator BIOLOGICAL

Treatment Group 1

Grass MATA MPL BIOLOGICAL

Treatment Group 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients must have a positive skin prick test for grass pollen allergen.
• Positive skin prick test to positive histamine control
• Negative skin prick test to negative control
• Specific IgE for grass pollen as documented by ImmunoCAP test with class ≥ 2
• A history of moderate to severe symptoms of seasonal allergic rhinitis and/or conjunctivitis due to grass (Pooideae) pollen exposure that required repeated use of antihistamines, nasal steroids, and/or leukotriene modifiers for relief of symptoms during the last two consecutive seasons prior to the study
• Males or non-pregnant, non-lactating females who are not of child-bearing potential or using effective contraception
• Patients who are normally active and otherwise judged to be in good health
• For patients with a history of asthma, forced expiratory volume in 1 second (FEV1) ≥ 80% of National Health and Nutrition Examination Surveys (NHANES) predicted, with a FEV1/forced vital capacity (FVC) ratio ≥ 70%.
• Able to observe the drug washout times listed in the Prohibited Medications Table below prior to screening
• Patients willing and able to attend required study visits and able to follow the protocol requirements.
• Patients willing and able to give written informed consent.

You may not qualify if:

• Symptoms outside the grass pollen season due to a perennial and/or non-grass seasonal allergen, if the patient is unable to avoid the offending allergen.
• Immunological disorders or other diseases that in the opinion of the investigator may pose a safety risk.
• Presence of moderate to severe asthma, characterized by the current use of inhaled steroids at a daily dose above 400 micrograms of budesonide (or equivalent)
• Emergency room visit or admission for asthma in the 12 months prior to Visit 1 or history of a life-threatening asthma attack ever.
• Presence of non-atopic rhinitis and/or rhino-sinusitis (with or without polyps).
• Presence of any skin conditions (skin abnormalities, tattoos etc.) which might interfere with the interpretation of the SPT results.
• Current diagnosis of type I diabetes. Patients with type II diabetes will only be allowed to participate at the discretion of the investigator.
• Treatment with a preparation containing MPL (e.g. Cervarix) within 6 months prior to screening
• Moderate to severe upper or lower respiratory tract infections requiring medication within 14 days of or a diagnosis of sinusitis within 30 days of randomisation
• Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis.
• Clinical history of allergy, hypersensitivity or intolerance to the excipients of the study medication.
• Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria.
• Unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated).
• Clinical history of immunodeficiency, including those who are on immunosuppressant therapy.
• Clinical history of recurrent idiopathic angioedema.

Sponsors & Collaborators

• Allergy Therapeutics: lead
• SynteractHCR: collaborator
• Metronomia Clinical Research GMBH: collaborator

Study Sites (4)

Vedas Research

Edison, New Jersey, United States

Location

Atlantic Reseach Center

Ocean City, New Jersey, 07712, United States

Location

STARx Asthma and Allergy Center

Springfield, New Jersey, 07081-2515, United States

Location

Allergy Partners of New Jersey

Teaneck, New Jersey, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

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

Study Officials

• Tim Higenbottam, MD, FRCP

  Allergy Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-blind

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 30, 2019
• Study Start: January 16, 2017
• Primary Completion: April 27, 2017
• Study Completion: April 27, 2017
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)