NCT02256553

Safety Study of MK-3641 and MK-7243 Co-administered in Adult Participants With Ragweed and Grass Pollen Induced Allergic Rhinitis (P08607, MK-3641-006)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: ALK-Abelló A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Events of local swelling include pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema or throat tightness.

Conditions

• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
BIOLOGICAL	MK-3641 12 Amb a 1-U (short ragweed extract)	12 units of Ambrosia artemisiifolia major allergen number 1 (Amb a 1-U) extract sublingual tablets
BIOLOGICAL	MK-7243 2800 BAU (Timothy grass extract)	2800 bioequivalent allergen units (BAU) of Phleum pratense extract sublingual tablets
DRUG	Rescue Medication	Self-injectable epinephrine, to be administered for an anaphylactic reaction, including symptoms/signs of upper airway obstruction.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-10-03
• Last updated: 2017-03-03
• Results posted: 2016-01-18