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)

NCT ID: NCT02256553

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-02-28

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.

Conditions

Rhinitis, Allergic, Seasonal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MK-3641+ MK-7243

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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

MK-7243 2800 BAU (Timothy grass extract)

Intervention Type: BIOLOGICAL

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

Rescue Medication

Intervention Type: DRUG

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

Interventions

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

Intervention Type: BIOLOGICAL

MK-7243 2800 BAU (Timothy grass extract)

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

Intervention Type: BIOLOGICAL

Rescue Medication

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

Intervention Type: DRUG

Other Intervention Names

SCH 039641; RAGWITEK®; SCH 697243; GRASTEK®

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ALK-Abelló A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 26755098 (View on PubMed)

Other Identifiers

P08607

Identifier Type: -

Identifier Source: org_study_id