A Study of Tolerability and Safety of Two New Doses of Grass MATA MPL

NCT02557633 | Completed Phase 1 DMC

• 1 other identifier: GrassMATAMPL102
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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. Two new cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) are being developed to compare with the current dose of 5100 SU. The purpose of this study is to evaluate the tolerability and safety of these two new cumulative dose regimens 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 go into a larger scale study to assess the efficacy and safety of the higher cumulative doses.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

• Number of AEs

  Aggregate of the number of AEs, adverse reaction complexes (ARCs; the total of treatment related injection site and systemic AEs experienced by a patient within a 24-hour period after an injection)

  8 weeks

• Premature discontinuation

  The frequency of premature discontinuation from treatment or study due to AEs between the treatment groups

  8 weeks

Secondary Outcomes (1)

• AEs of special interest

  one year

Study Arms (3)

Placebo

PLACEBO COMPARATOR

2% w/v L-Tyrosine

Biological: Placebo

Grass MATA MPL 10200 SU

EXPERIMENTAL

Grass MATA MPL cumulative dose 10200 SU given as six injections of placebo, placebo, 600SU, 1600SU, 4000SU and 4000SU.

Biological: Grass MATA MPL 10200

Grass MATA MPL 18200 SU

EXPERIMENTAL

Grass MATA MPL cumulative dose 18200 SU given as six injections of 600SU, 1600SU, 4000SU, 4000SU, 4000SU and 4000SU.

Biological: Grass MATA MPL 18200

Interventions

Grass MATA MPL 10200 BIOLOGICAL

Grass MATA MPL 10200 SU

Grass MATA MPL 18200 BIOLOGICAL

Grass MATA MPL 18200 SU

Placebo BIOLOGICAL

Placebo

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 radioallergosorbent or equivalent test with class ≥ 2
• History of at least 2 seasons of moderate to severe seasonal rhinoconjunctivitis due to an IgE - mediated allergy to pollen from grass
• Males or non-pregnant, non-lactating females who are:
• Post-menopausal (defined as at least 12 months natural spontaneous amenorrhea or at least 6 weeks following surgical menopause, i.e. bilateral oophorectomy)
• Naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation)
• Of childbearing potential - with negative urinary and serological pregnancy test and use at least one of the following contraception methods:
• Stable hormonal contraceptive for ≥ 90 days prior to Visit 1 and at least 7 days after the final injection. If \< 90 days prior to the study, additional use of a double barrier method until 90 days reached is required.
• Placement of an intrauterine device (IUD) or intrauterine system
• Use of barrier methods of contraception (e.g., condom or occlusive cap) with spermicidal foam/gel/film/cream /suppository
• Use of double barrier methods of contraception (e.g., male condom with diaphragm, male condom with cervical cap)
• Patients who are normally active and otherwise judged to be in good health
• Patients must be willing and able to attend required study visits.

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.
• Concurrent disease that might complicate or interfere with investigation or evaluation of the study medications or the skin prick test result, such as:
• Any ocular disorder (other than allergic conjunctivitis) including presumed infectious ocular disease (bacterial, fungal, viral, etc.), which could interfere with the evaluation of the study medication Rhinitis medicamentosa
• Documented evidence of acute or significant chronic sinusitis, upper or lower respiratory tract infection within 30 days before Visit 2 as determined by the Investigator
• Asthma, with the exception of mild intermittent asthma
• 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 acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence
• Presence of emphysema or bronchiectasis
• Auto-immune disease, cancer, or concomitant illness that in the opinion of the Investigator would pose a safety risk or compromise the interpretation of study results
• Use of oral, intramuscular, intravenous corticosteroids, or potent or super-potent topical corticosteroids, from 30 days prior to screening up to Visit 8
• Presence of tattoos or other skin abnormalities in the upper arms which would prevent an accurate assessment of local skin reaction
• Allergy, hypersensitivity or intolerance to the excipients of the study medication
• Anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis
• Immunodeficiency, including those who are on immunosuppressant therapy
• Recurrent idiopathic angioedema

Sponsors & Collaborators

• Allergy Therapeutics: lead
• Inflamax Research Incorporated: collaborator
• Metronomia Clinical Research GMBH: collaborator

Study Sites (2)

Inflamax Research, Inc.

Neptune City, New Jersey, 07753, United States

Location

Inflamx Research

Newark, New Jersey, 07105, United States

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

• Tim Higenbottam, DSc MD FRCP FFPM

  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

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 23, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2016
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

US (2)