NCT02676765

Brief Summary

The purpose of this study is to determine if sublingual allergen immunotherapy tablets work by inducing a state of desensitization in mast cells and basophils.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2018

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

March 18, 2022

Completed
Last Updated

March 18, 2022

Status Verified

February 1, 2022

Enrollment Period

1.6 years

First QC Date

February 3, 2016

Results QC Date

February 21, 2022

Last Update Submit

February 21, 2022

Conditions

Immunologic Desensitization

Keywords

Allergic rhinitisImmunotherapy, AllergenSublingual Immunotherapy

Outcome Measures

Primary Outcomes (2)

  • Change in PC3

    Change in the dose of allergen eliciting a wheal 3 mm greater than negative control upon skin prick testing (PC3)

    Assessed at 2 weeks and at the end of the study (2 months)

  • Change in Basophil Activation

    Change in the dose of allergen eliciting a 50% increase in number of basophils positive for CD63 and/or CD203c relative to negative and positive controls

    Assessed at 2 weeks and at the end of the study (2 months)

Secondary Outcomes (2)

  • Cross-desensitization - PC3

    Assessed at 2 weeks and at the end of the study (2 months)

  • Cross-desensitization - Basophil Activation

    Assessed at 2 weeks and at the end of the study (2 months)

Other Outcomes (1)

  • Percent Allergen-specific IgE

    Assessed at enrollment, at 2 weeks, and at the end of the study (2 months)

Study Arms (2)

sublingual allergen tablets

EXPERIMENTAL

Subjects will be administered a sublingual allergen tablet customized to their individual allergic sensitization.

Drug: allergen extract tablet

Placebo

PLACEBO COMPARATOR

Subjects will be administered placebo sublingual tablets

Drug: Placebo tablet

Interventions

allergen extract tabletDRUG

1 allergen extract tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet

Also known as: Ragwitek, Grastek
sublingual allergen tablets
Placebo tabletDRUG

1 placebo tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Verified allergic sensitivity to either Timothy Grass or Short Ragweed pollen (primary allergen)
  • Verified allergic sensitivity to at least one allergen in addition to the primary allergen

You may not qualify if:

  • Negative skin testing to Timothy Grass or Short Ragweed pollen and at least one other environmental allergen
  • Dermatographism
  • Severe dermatologic condition that may interfere with skin testing
  • Pregnancy
  • H1 receptor antihistamine taken within 7 days of testing
  • Systemic steroids
  • Omalizumab taken at any time in the past
  • Receiving or received allergen immunotherapy
  • Desensitized to any drug within 6 months
  • Current uncontrolled or severe asthma
  • Eosinophilic esophagitis
  • Significant pulmonary, cardiovascular, renal, hepatobiliary, or neurological diseases, or another disease process felt to put a subject at increased risk for adverse events
  • Hypersensitivity to any of the inactive ingredients in the allergen extract tablets
  • History of mental illness or drug or alcohol abuse that could interfere with the ability to comply with study requirements
  • Inability or unwillingness to give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (5)

  • Zhao W, Gomez G, Macey M, Kepley CL, Schwartz LB. In vitro desensitization of human skin mast cells. J Clin Immunol. 2012 Feb;32(1):150-60. doi: 10.1007/s10875-011-9605-8. Epub 2011 Oct 19.

    PMID: 22009002BACKGROUND

  • Maloney J, Bernstein DI, Nelson H, Creticos P, Hebert J, Noonan M, Skoner D, Zhou Y, Kaur A, Nolte H. Efficacy and safety of grass sublingual immunotherapy tablet, MK-7243: a large randomized controlled trial. Ann Allergy Asthma Immunol. 2014 Feb;112(2):146-153.e2. doi: 10.1016/j.anai.2013.11.018. Epub 2013 Dec 21.

    PMID: 24468255BACKGROUND

  • Creticos PS, Maloney J, Bernstein DI, Casale T, Kaur A, Fisher R, Liu N, Murphy K, Nekam K, Nolte H. Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults. J Allergy Clin Immunol. 2013 May;131(5):1342-9.e6. doi: 10.1016/j.jaci.2013.03.019.

    PMID: 23622121BACKGROUND

  • Cockcroft DW, Davis BE, Boulet LP, Deschesnes F, Gauvreau GM, O'Byrne PM, Watson RM. The links between allergen skin test sensitivity, airway responsiveness and airway response to allergen. Allergy. 2005 Jan;60(1):56-9. doi: 10.1111/j.1398-9995.2004.00612.x.

    PMID: 15575931BACKGROUND

  • Niederberger V, Laffer S, Froschl R, Kraft D, Rumpold H, Kapiotis S, Valenta R, Spitzauer S. IgE antibodies to recombinant pollen allergens (Phl p 1, Phl p 2, Phl p 5, and Bet v 2) account for a high percentage of grass pollen-specific IgE. J Allergy Clin Immunol. 1998 Feb;101(2 Pt 1):258-64. doi: 10.1016/s0091-6749(98)70391-4.

    PMID: 9500760BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Allergens

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AntigensBiological Factors

Results Point of Contact

Title
Dr. Brant Ward
Organization
Virginia Commonwealth University
brant.ward@vcuhealth.org
804-828-1941

Study Officials

  • Lawrence B Schwartz, M.D.,Ph.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 8, 2016

Study Start

June 1, 2016

Primary Completion

January 18, 2018

Study Completion

January 18, 2018

Last Updated

March 18, 2022

Results First Posted

March 18, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)