CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 102 enrolled
Drug / intervention
MK-3641 12 Amb a 1-U (short ragweed extract) +2 morebiological
Likely dose
MK-3641 12 Amb a 1-U (short ragweed extract) 12 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02256553
NCT02256553Phase 4Completed
CompareCT.gov

A Phase IV, Open-label, Safety and Tolerability Trial of MK-3641 and MK-7243 Coadministered in Subjects At Least 18 Years of Age With Ragweed and Grass Pollen Induced Allergic Rhinitis With or Without Conjunctivitis

ALK-Abelló A/S·interventional·Posted Oct 3, 2014·Updated Mar 3, 2017

In Brief

A Phase 4 clinical trial evaluating MK-3641 12 Amb a 1-U (short ragweed extract), MK-7243 2800 BAU (Timothy grass extract), and 1 other intervention for Rhinitis, Allergic, Seasonal. Completed, enrolled 102 participants.

Detailed Summary

The purpose of this study is to assess the safety and tolerability of MK-3641 (short ragweed \[Ambrosia artemisiifolia\] extract, SCH 039641, RAGWITEK®) sublingual tablets and MK-7243 (Timothy grass \[Phleum pratense\] extract, SCH 697243, GRASTEK®) sublingual tablets co-administered in participants 18 through 65 years of age with both ragweed- and grass polled-induced allergic rhinitis, with or without conjunctivitis and with or without asthma. The primary endpoint is the percentage of participants who experience at least one event of local swelling after co-administration of MK-3641 and MK-7243 sublingual tablets.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhinitis, Allergic, Seasonal
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 3, 2014
Enrollment StartOct 1, 2014
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.7 years ago

Interventions

MK-3641 12 Amb a 1-U (short ragweed extract)biological

12 units of Ambrosia artemisiifolia major allergen number 1 (Amb a 1-U) extract sublingual tablets

MK-7243 2800 BAU (Timothy grass extract)biological

2800 bioequivalent allergen units (BAU) of Phleum pratense extract sublingual tablets

Rescue Medicationdrug

Self-injectable epinephrine, to be administered for an anaphylactic reaction, including symptoms/signs of upper airway obstruction.