Clinical trial 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinitis, Allergic, Seasonal
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2014-10-03
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Clinical history of physician-diagnosed ragweed- and grass pollen-induced rhinitis with or without conjunctivitis of \>1 year duration, with or without asthma
* Female participants of childbearing potential must have a negative urine pregnancy test at Screening and Randomization Visits and must agree to remain abstinent or use (or have their partner use) any one of the acceptable methods of birth control within the projected duration of the study. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy, hormonal contraception.

Exclusion Criteria:

* Unstable, uncontrolled or severe asthma treated with long-acting beta agonists (LABAs) at the time of Screening
* Received immunosuppressive treatment within 3 months prior to Randomization (except steroids for allergic reactions other than asthma)
* History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause, or inhalant allergen
* Diagnosis of eosinophilic esophagitis
* History of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy
* Female and breastfeeding, pregnant or intending to become pregnant
* Received another form of allergen immunotherapy with the past month
* Previously exposed to MK-3641 (RAGWITEK®) or other sublingual ragweed immunotherapy
* Previously exposed to MK-7243 (GRASTEK®) or other sublingual grass immunotherapy
* Known history of allergy, hypersensitivity, or intolerance to the excipient ingredients of the study drug (except for Ambrosia artemisiifolia and/or Phleum pratense), or self-injectable epinephrine
* Unable to or will not comply with the use of self-injectable epinephrine
* Used an investigational drug within 30 days prior to Screening Visit, or plans to participate in another interventional clinical trial during the duration of this trial
* Family member of the investigational or sponsor staff involved in this trial
* Participating in this same trial at another investigational site.

Primary outcomes:
measure: Percentage of Participants Who Experienced at Least One Event of Local Swelling
timeFrame: During Period I, Period II and Period III (Up to 6 weeks)
Secondary outcomes:
measure: Percentage of Participants Who Experienced at Least One Event of Local Application Site Reaction
timeFrame: During Period I, Period II and Period III (Up to 6 weeks)
measure: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)
timeFrame: During Period I, Period II and Period III (Up to 6 weeks)
measure: Percentage of Participants Who Experienced at Least One Local Application Site Reaction That Required Symptomatic Treatment
timeFrame: During Period I, Period II and Period III (Up to 6 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Maloney J, Berman G, Gagnon R, Bernstein DI, Nelson HS, Kleine-Tebbe J, Kaur A, Li Q, Nolte H. Sequential Treatment Initiation with Timothy Grass and Ragweed Sublingual Immunotherapy Tablets Followed by Simultaneous Treatment Is Well Tolerated. J Allergy Clin Immunol Pract. 2016 Mar-Apr;4(2):301-9.e2. doi: 10.1016/j.jaip.2015.11.004. Epub 2016 Jan 2.