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

NCT01385371 | Completed Phase 3 Results DMC

• 2 other identifiers: P08067MK-7243-001
• Study Type: interventional
• Target: 1,501
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS)

  The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications. For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.

  Entire GPS (expected average duration of 5 to 6 weeks)

Secondary Outcomes (7)

• Average Rhinoconjunctivitis DSS Over the Entire GPS

  Entire GPS (expected average duration of 5 to 6 weeks)

• Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS

  Peak GPS (expected average duration of 2 weeks)

• Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS

  Peak GPS (expected average duration of 2 weeks)

• Average Rhinoconjunctivitis DMS Over the Entire GPS

  Entire GPS (expected average duration of 5 to 6 weeks)

• Average Rhinoconjunctivitis DSS Over the Peak GPS

  Peak GPS (expected average duration of 2 weeks)

Study Arms (2)

SCH 697243

EXPERIMENTAL

Biological: Grass (Phleum pratense) pollen allergen extract

Placebo

PLACEBO COMPARATOR

Biological: Placebo for SCH 697243

Interventions

Grass (Phleum pratense) pollen allergen extract BIOLOGICAL

One dissolving tablet sublingually once daily

Also known as: SCH 697243

SCH 697243

Placebo for SCH 697243 BIOLOGICAL

One dissolving tablet sublingually once daily

Placebo

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Related Publications (3)

• 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.

  PMID: 24468255 RESULT

• 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.

  PMID: 26507709 DERIVED

• 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.

  PMID: 25685162 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Conjunctivitis

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Conjunctival Diseases; Eye Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: June 30, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 3, 2017
• Results First Posted: September 10, 2013

Record last verified: 2017-01