A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751)

NCT01469182 | Completed Phase 3 Results

• 2 other identifiers: P05751MK-3641
• Study Type: interventional
• Target: 914
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study assessed the safety profile of short ragweed (Ambrosia artemisiifolia) in participants with ragweed-induced rhinoconjunctivitis with or without asthma. The primary objective was to compare treatment-emergent adverse events (AEs) for participants treated with short ragweed allergy immunotherapy tablet (AIT) with those treated with placebo.

Conditions

Allergy

Keywords

Immunology

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events (AEs)

  Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number 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 35

Secondary Outcomes (8)

• Number of Participants Reporting Oral Pruritus.

  Up to Day 35

• Number of Participants Reporting Ear Pruritus

  Up to Day 35

• Number of Participants Reporting Throat Irritation

  Up to Day 35

• Number of Participants Reporting Mouth Oedema

  Up to Day 35

• Number of Participants Reporting Eye Pruritus

  Up to Day 35

Study Arms (2)

SCH 39641 12 Amb a 1-U

EXPERIMENTAL

12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an AIT, sublingual, once daily.

Biological: SCH 39641

Placebo

PLACEBO COMPARATOR

Matching placebo tablet, sublingual, once daily.

Drug: Placebo for SCH 39641

Interventions

SCH 39641 BIOLOGICAL

Rapidly dissolving tablet sublingually once daily

Also known as: MK-3641

SCH 39641 12 Amb a 1-U

Placebo for SCH 39641 DRUG

Rapidly dissolving tablet sublingually once daily

Placebo

Eligibility Criteria

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

You may qualify if:

• Clinical history of physician-diagnosed ragweed-induced allergic rhinoconjunctivitis of 2 years duration or more, with or without asthma
• Must have a positive skin prick test response to Ambrosia artemisiifolia
• Must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value
• Clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor
• Females of child-bearing potential must agree to use medically accepted methods of contraception

You may not qualify if:

• Unstable asthma or has experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids in previous 3 months
• Received an immunosuppressive treatment within 3 months
• History of anaphylaxis with cardio-respiratory symptoms.
• History of chronic urticaria or angioedema
• Current severe atopic dermatitis
• Female subject who is breastfeeding, pregnant, or intending to become pregnant
• Has received maintenance doses of immunotherapy with ragweed extract for ≥1 month within the last 5 years
• History of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine
• Unable to or will not comply with the use of self-injectable epinephrine
• Participating in any other clinical trial

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

Hypersensitivity

Condition Hierarchy (Ancestors)

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: November 10, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 3, 2017
• Results First Posted: June 5, 2014

Record last verified: 2017-01