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Completed

NCT Number: NCT01469182

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

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.

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

SCH 39641

Biological

Rapidly dissolving tablet sublingually once daily

Other names: MK-3641

Placebo for SCH 39641

Drug

Rapidly dissolving tablet sublingually once daily

Primary outcomes

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

    Time frame: Up to Day 35

    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.

Secondary outcomes

  1. Number of Participants Reporting Oral Pruritus.

    Time frame: Up to Day 35

    Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with oral pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

  2. Number of Participants Reporting Ear Pruritus

    Time frame: Up to Day 35

    Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with ear pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

  3. Number of Participants Reporting Throat Irritation

    Time frame: Up to Day 35

    Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with throat irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

  4. Number of Participants Reporting Mouth Oedema

    Time frame: Up to Day 35

    Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with mouth oedema were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

  5. Number of Participants Reporting Eye Pruritus

    Time frame: Up to Day 35

    Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with eye pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

  6. Number of Participants Reporting Nasal Passage Irritation

    Time frame: Up to Day 35

    Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with nasal passage irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

  7. Number of Participants Reporting Skin Pruritus

    Time frame: Up to Day 35

    Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with skin pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

  8. Number of Participants Who Discontinued Due to Treatment-emergent AEs

    Time frame: Up to Day 28

    Participants were treated with either SCH 39641 12 Amb a 1-U or placebo for 28 days, and the number who discontinued due to 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.

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study title

A 28-Day Study Evaluating the Safety of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet (SCH 39641/MK-3641) Treatment in Ragweed Allergic Adults (Phase 3, Protocol No.P05751)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 10, 2011
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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