NCT02245360

Brief Summary

To investigate the immunologic effects and safety of 60-day treatment of the Standardized Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

15 active sites

Status
completed

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

September 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
9 months until next milestone

Results Posted

Study results publicly available

December 8, 2015

Completed
Last Updated

January 11, 2016

Status Verified

December 1, 2015

Enrollment Period

5 months

First QC Date

September 17, 2014

Results QC Date

November 3, 2015

Last Update Submit

December 9, 2015

Conditions

Seasonal Allergic Rhinitis

Keywords

GRAZAX

Outcome Measures

Primary Outcomes (1)

  • The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum

    measurement of IgG4 in serum

    baseline versus end of treatment (approx. 60 days)

Secondary Outcomes (1)

  • Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment

    baseline versus end of treatment (approx. 60 days)

Study Arms (2)

Grass tablet 75,000 SQ-T

EXPERIMENTAL

Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)

Drug: Phleum pratense grass pollen allergen extract

Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

Phleum pratense grass pollen allergen extractDRUG

Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days

Also known as: GRAZAX/GRASTEK
Grass tablet 75,000 SQ-T
placeboDRUG

placebo tablet given once daily over 60 days

Placebo

Eligibility Criteria

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

You may qualify if:

  • clinical history consistent with grass pollen-induced allergic rhinoconjunctivitis.
  • Use of symptomatic treatment of grass pollen-induced allergic rhinoconjunctivitis.
  • Positive skin prick test response (wheal diameter ≥3 mm) to Phleum pratense.
  • If asthma, daily use of Inhaled corticosteroid (ICS) should be ≤400 microgram budesonide or equivalent
  • Moderate or higher level of Phleum pratense specific IgE (Immunoglobulin E) (defined as ≥IgE Class 2; or ≥0.70 Kilo Units/liter (kU/L))

You may not qualify if:

  • Reduced lung function (defined as FEV1 \< 70% (FEV1=Forced Expiratory Volume in 1 second) of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2
  • Clinical history of uncontrolled asthma within 3 months prior to the screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Research facility ID ORG-001086

Moscow, 105077, Russia

Location

Research facility ID ORG-001018

Moscow, 115446, Russia

Location

Research facility ID ORG-001005

Moscow, 115478, Russia

Location

Research facility ID ORG-001009

Moscow, 119333, Russia

Location

Research facility ID ORG-001016

Moscow, 119991, Russia

Location

Research facility ID ORG-001006

Moscow, 123182, Russia

Location

Research facility ID ORG-001085

Moscow, 123182, Russia

Location

Research facility ID ORG-001014

Moscow, 142190, Russia

Location

Research facility ID ORG-001007

Saint Petersburg, 193231, Russia

Location

Research facility ID ORG-001019

Saint Petersburg, 195030, Russia

Location

Research facility ID ORG-001008

Saint Petersburg, 198216, Russia

Location

Research facility ID ORG-001015

Samara, 443099, Russia

Location

Research facility ID ORG-001021

Saratov, 410028, Russia

Location

Research facility ID ORG-001017

Smolensk, 214019, Russia

Location

Research facility ID ORG-001020

Ufa, 450000, Russia

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Grazax

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Dmitri Kazei MD, PhD
Organization
Abbott
dmitri.kazei@abbott.com
+31 294477008

Study Officials

  • Dmitri Kazei, MD PhD

    Abbott

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 19, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

January 11, 2016

Results First Posted

December 8, 2015

Record last verified: 2015-12

Locations

RU(15)