A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067)

NCT ID: NCT01385371

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1501 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-08-31

Brief Summary

This is a study to evaluate the efficacy and safety of grass sublingual tablet (SCH 697243) versus placebo in the treatment of grass pollen-induced allergic hayfever symptoms. Participants will receive either the sublingual grass tablet or a placebo tablet during the study. It is expected that those participants receiving the active sublingual grass tablet will have less hayfever symptoms and need less medications to treat hayfever symptoms during the grass pollen season.

Conditions

Rhinitis Allergic; Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SCH 697243

Group Type: EXPERIMENTAL

Grass (Phleum pratense) pollen allergen extract

Intervention Type: BIOLOGICAL

One dissolving tablet sublingually once daily

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo for SCH 697243

Intervention Type: BIOLOGICAL

One dissolving tablet sublingually once daily

Interventions

Grass (Phleum pratense) pollen allergen extract

One dissolving tablet sublingually once daily

Intervention Type: BIOLOGICAL

Placebo for SCH 697243

One dissolving tablet sublingually once daily

Intervention Type: BIOLOGICAL

Other Intervention Names

SCH 697243

Eligibility Criteria

Inclusion Criteria

• Must have a clinical history of significant allergic rhinoconjunctivitis to grass (with or without asthma)
• Must have a positive skin prick test response to Phleum pratense (Timothy grass)
• Must be positive for specific immunoglobulin E (IgE) against Phleum pratense (Timothy grass)
• Must have an forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at

Screening

• Safety laboratory tests and vital signs conducted at the Screening Visit must be within normal

limits or clinically acceptable to the investigator/sponsor

Exclusion Criteria

• Has a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to another allergen during or potentially overlapping the GPS
• Has a clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the participant is regularly exposed
• Has received an immunosuppressive treatment within 3 months prior to the Screening Visit
• Has a clinical history of severe asthma
• Has a history of anaphylaxis with cardiorespiratory symptoms
• Has a history of self-injectable epinephrine use
• Has a history of chronic urticaria and angioedema
• Has a clinical history of chronic sinusitis during the 2 years prior to the Screening Visit
• Has current severe atopic dermatitis
• Is breast-feeding, pregnant, or intending to become pregnant
• Had previous treatment by immunotherapy with any grass pollen allergen for more than 1 month within the 5 years prior to the Screening Visit
• Ongoing treatment with any specific immunotherapy at the time of the Screening Visit
• Has a known history of allergy, hypersensitivity or intolerance to the ingredients of the study drug (except for Phleum pratense), rescue medications, or self-injectable epinephrine
• Has any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. Specific examples include but are not limited to hypertension being treated with beta blockers, coronary artery disease, arrhythmia, stroke, ocular conditions requiring topical beta blockers, any condition requiring the use of beta blockers
• Has used any investigational drugs within 30 days of the Screening Visit
• Is participating in any other clinical study
• Is a family member of the investigational study staff conducting this study
• Is unable to meet medication washout requirements
• Is unlikely to be able to complete the trial, for any reason, or likely to travel for extended periods of time during the GPS, which in the opinion of the investigator will compromise the data
• Has a clinically significant abnormal vital sign or laboratory value that would preclude participation in the study

• Minimum Eligible Age: 5 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

References

Maloney J, Bernstein DI, Nelson H, Creticos P, Hebert J, Noonan M, Skoner D, Zhou Y, Kaur A, Nolte H. Efficacy and safety of grass sublingual immunotherapy tablet, MK-7243: a large randomized controlled trial. Ann Allergy Asthma Immunol. 2014 Feb;112(2):146-153.e2. doi: 10.1016/j.anai.2013.11.018. Epub 2013 Dec 21.

Reference Type: RESULT

PMID: 24468255 (View on PubMed)

Nolte M, Barber D, Maloney J, Li Z, Kaur A, Galan A, Andersen JS, Nolte H. Timothy specific IgE levels are associated with efficacy and safety of timothy grass sublingual immunotherapy tablet. Ann Allergy Asthma Immunol. 2015 Dec;115(6):509-515.e2. doi: 10.1016/j.anai.2015.09.018. Epub 2015 Oct 21.

Reference Type: DERIVED

PMID: 26507709 (View on PubMed)

Hebert J, Blaiss M, Waserman S, Kim H, Creticos P, Maloney J, Kaur A, Li Z, Nelson H, Nolte H. The efficacy and safety of the Timothy grass allergy sublingual immunotherapy tablet in Canadian adults and children. Allergy Asthma Clin Immunol. 2014 Oct 30;10(1):53. doi: 10.1186/1710-1492-10-53. eCollection 2014.

Reference Type: DERIVED

PMID: 25685162 (View on PubMed)

Other Identifiers

MK-7243-001

Identifier Type: OTHER

Identifier Source: secondary_id

P08067

Identifier Type: -

Identifier Source: org_study_id