Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and Older (Study P06081)

NCT00978029 | Completed Phase 2 Results

• 2 other identifiers: P06081MK-3641-004
• Study Type: interventional
• Target: 203
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to assess the safety and tolerability of a ragweed allergy immunotherapy tablet (AIT) administered sublingually (under-the tongue) in subjects 50 years of age and older with ragweed-induced rhinoconjunctivitis, with or without asthma.

Conditions

Rhinoconjunctivitis; Rhinitis; Conjunctivitis; Allergy

Keywords

immunotherapy

Outcome Measures

Primary Outcomes (1)

• The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)

  Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.

  Up to Day 42

Secondary Outcomes (5)

• Proportion of Participants Reporting Oral Pruritus

  Up to Day 42

• Proportion of Participants Reporting Ear Pruritus

  Up to Day 42

• Proportion of Participants Reporting Throat Irritation

  Up to Day 42

• Proportion of Participants Reporting Mouth Oedema

  Up to Day 42

• Proportion of Participants Who Discontinued Due to Adverse Events.

  Up to Day 28

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Matching placebo tablet sublingual, once daily

Drug: Placebo

SCH 39641 6 Amb a 1-U

EXPERIMENTAL

6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an AIT, sublingual, once daily

Biological: SCH 39641

SCH 39641 12 Amb a 1-U

EXPERIMENTAL

12 Amb a 1-U in an AIT, sublingual, once daily

Biological: SCH 39641

Interventions

Placebo DRUG

Placebo sublingual tablet, once daily

Placebo

SCH 39641 BIOLOGICAL

Allergy immunotherapy tablet (sublingual)

Also known as: MK-3641

SCH 39641 6 Amb a 1-U

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be 50 years of age or older, of either sex, and of any race/ethnicity.
• Subject must have a clinical history of ragweed-induced allergic rhinoconjunctivitis with or without asthma.
• Subject must have a positive skin prick test response to Ambrosia artemisiifolia at the Screening Visit
• Subject must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at the Screening Visit and at Randomization.
• A subject's clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator.

You may not qualify if:

• Subject with asthma who requires inhaled corticosteroids for the treatment of their asthma during the study period.
• Subject requiring anti-allergy medications during the time period from randomization to study completion.
• Subject who has received an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
• Subject with a history of anaphylaxis with cardiorespiratory symptoms.
• Subject with a history of chronic urticaria or angioedema.
• Subject with current severe atopic dermatitis.
• Female subject who is breastfeeding, pregnant, or intending to become pregnant.
• Subject with a history of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine.
• Subject with a history of self-injectable epinephrine use.

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Related Publications (1)

• Nolte H, Amar N, Bernstein DI, Lanier BQ, Creticos P, Berman G, Kaur A, Hebert J, Maloney J. Safety and tolerability of a short ragweed sublingual immunotherapy tablet. Ann Allergy Asthma Immunol. 2014 Jul;113(1):93-100.e3. doi: 10.1016/j.anai.2014.04.018. Epub 2014 May 14.

  PMID: 24836393 DERIVED

MeSH Terms

Conditions

Rhinitis; Conjunctivitis; Hypersensitivity

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Conjunctival Diseases; Eye Diseases; Immune System 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 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 16, 2009
• Study Start: November 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 3, 2017
• Results First Posted: May 23, 2014

Record last verified: 2017-01