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Phase III Cat-PAD Study

This study is currently recruiting participants.
Verified February 2013 by Circassia Limited
Sponsor:
Collaborator:
inVentiv Health Clinical
Information provided by (Responsible Party):
Circassia Limited
ClinicalTrials.gov Identifier:
NCT01620762
First received: May 30, 2012
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to compare the treatment effect of two treatment regimens of Cat-PAD vs placebo and to evaluates the treatment effect of Cat-PAD on symptoms, rescue medication usage and Quality of Life.


Condition Intervention Phase
Rhinoconjunctivitis
 Drug: Cat-PAD
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomised, Placebo-Controlled Multi-Centre Field Study to Assess the Efficacy and Safety of Cat-PAD Peptide Immunotherapy in Cat Allergic Subjects

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by Circassia Limited:

Primary Outcome Measures:
  • Combined Score of symptoms and allergy medication [ Time Frame: up to 52 weeks after randomisation ] [ Designated as safety issue: No ]
    Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication


Secondary Outcome Measures:
  • Symptom Scores [ Time Frame: up to 52 weeks after randomisation ] [ Designated as safety issue: No ]
    Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects

  • Rescue Medication Use [ Time Frame: up to 52 weeks after randomisation ] [ Designated as safety issue: No ]
    Use of allergy medication to help allergy symptoms

  • Quality of Life [ Time Frame: up to 52 weeks after randomisation ] [ Designated as safety issue: No ]
  • Incidence and frequency of Adverse Events [ Time Frame: up to 52 weeks after randomisation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1182
Study Start Date: October 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cat-Pad Treatment 1
Cat-PAD Treatment 1
 Drug: Cat-PAD
1 dose every 4 weeks
Experimental: Cat-PAD Treatment 2
Cat-PAD Treatment regimen 2
 Drug: Cat-PAD
1 dose every 4 weeks
Drug: Placebo
1 dose every 4 weeks
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
1 dose every 4 weeks

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Male or female, aged 12-65 years.
  • Moderate to severe rhinoconjunctivitis on exposure to cats for at least 2 years.
  • Subjects may optionally also have GINA Step 1 controlled asthma.
  • Positive skin prick test to cat hair.
  • Cat dander specific IgE ≥0.35 kU/L.

Exclusion Criteria

  • Asthma falling under the GINA definitions "partly controlled" and "uncontrolled" or Steps 2 to 5.
  • FEV1 <80% of predicted.
  • Clinically significant confounding symptoms of allergy to seasonal allergens during the final evaluation period.
  • Skin prick test 5 mm greater than the negative control to perennial allergens or animal dander (other than cat) which cannot be avoided during the study.
  • Significant symptoms of another clinically relevant illness that is likely to affect scoring of rhinoconjunctivitis symptoms.
  • Clinically relevant abnormalities detected on physical examination.
  • History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620762

Contacts
Contact: Doreen Barrett doreen.barrett@inventivhealth.com
Contact: Joanna Jarosiewicz jjarosiewicz@pharmanet-i3.com

  Show 87 Study Locations
Sponsors and Collaborators
Circassia Limited
inVentiv Health Clinical
Investigators
Principal Investigator: Harold Nelson, MD Jewish National Health
  More Information

No publications provided

Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT01620762     History of Changes
Other Study ID Numbers: CP007
Study First Received: May 30, 2012
Last Updated: February 25, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Belgium: Directorate general for the protection of Public health: Medicines
Czech Republic: State Institute for Drug Control
Germany: Paul-Ehrlich-Institut
Hungary: Ministry of Health, Social and Family Affairs
Poland: Ministry of Health

Keywords provided by Circassia Limited:
Cat allergy
Rhinoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013