Back to resultsSafety Study of MK-3641 and MK-7243 Co-administered in Adult Participants With Ragweed and Grass Pollen Induced Allergic Rhinitis (P08607, MK-3641-006)
Primary Purpose
Rhinitis, Allergic, Seasonal
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK-3641 12 Amb a 1-U (short ragweed extract)
MK-7243 2800 BAU (Timothy grass extract)
Rescue Medication
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Seasonal
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MK-3641+ MK-7243
Arm Description
Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Experienced at Least One Event of Local Swelling
Events of local swelling included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, or throat tightness. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the World Allergy Organization (WAO) as local side effects of sublingual immunotherapy (SLIT) that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.
Secondary Outcome Measures
Percentage of Participants Who Experienced at Least One Event of Local Application Site Reaction
Events of local application site reactions included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, throat tightness, lip swelling/edema, ear pruritus, dysphagia, oral discomfort, glossodynia, oral pruritus, hypoaesthesia oral, throat irritation, paraesthesia oral or stomatitis. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the WAO as local side effects of SLIT that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, was also an AE.
Percentage of Participants Who Experienced at Least One Local Application Site Reaction That Required Symptomatic Treatment
Events of local application site reactions included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, throat tightness, lip swelling/edema, ear pruritus, dysphagia, oral discomfort, glossodynia, oral pruritus, hypoaesthesia oral, throat irritation, paraesthesia oral or stomatitis. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the WAO as local side effects of SLIT that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02256553
Brief Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALK-Abelló A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MK-3641+ MK-7243
Arm Type
Experimental
Arm Description
Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
Intervention Type
Biological
Intervention Name(s)
MK-3641 12 Amb a 1-U (short ragweed extract)
Other Intervention Name(s)
SCH 039641, RAGWITEK®
Intervention Description
12 units of Ambrosia artemisiifolia major allergen number 1 (Amb a 1-U) extract sublingual tablets
Intervention Type
Biological
Intervention Name(s)
MK-7243 2800 BAU (Timothy grass extract)
Other Intervention Name(s)
SCH 697243, GRASTEK®
Intervention Description
2800 bioequivalent allergen units (BAU) of Phleum pratense extract sublingual tablets
Intervention Type
Drug
Intervention Name(s)
Rescue Medication
Intervention Description
Self-injectable epinephrine, to be administered for an anaphylactic reaction, including symptoms/signs of upper airway obstruction.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experienced at Least One Event of Local Swelling
Description
Events of local swelling included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, or throat tightness. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the World Allergy Organization (WAO) as local side effects of sublingual immunotherapy (SLIT) that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.
Time Frame
During Period I, Period II and Period III (Up to 6 weeks)
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Experienced at Least One Event of Local Application Site Reaction
Description
Events of local application site reactions included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, throat tightness, lip swelling/edema, ear pruritus, dysphagia, oral discomfort, glossodynia, oral pruritus, hypoaesthesia oral, throat irritation, paraesthesia oral or stomatitis. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the WAO as local side effects of SLIT that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.
Time Frame
During Period I, Period II and Period III (Up to 6 weeks)
Title
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)
Description
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, was also an AE.
Time Frame
During Period I, Period II and Period III (Up to 6 weeks)
Title
Percentage of Participants Who Experienced at Least One Local Application Site Reaction That Required Symptomatic Treatment
Description
Events of local application site reactions included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, throat tightness, lip swelling/edema, ear pruritus, dysphagia, oral discomfort, glossodynia, oral pruritus, hypoaesthesia oral, throat irritation, paraesthesia oral or stomatitis. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the WAO as local side effects of SLIT that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.
Time Frame
During Period I, Period II and Period III (Up to 6 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
26755098
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.
Results Reference
result
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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)
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