Phase III Cat-PAD Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Rhinoconjunctivitis

In brief

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.

Key facts

Study ID

NCT01620762

Run by

Circassia Limited

People needed

1408

Starts

2012-10-01

Last updated by the study team

2018-06-15

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Wheat Ridge, Colorado, United States
• Study site — Eagle, Idaho, United States
• Study site — Meridian, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Evanston, Illinois, United States
• Study site — Forrest, Illinois, United States
• Study site — Normal, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Overland Park, Kansas, United States
• Study site — Bangor, Maine, United States
• Study site — Brockton, Massachusetts, United States
• Study site — Ypsilanti, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Bozeman, Montana, United States
• Study site — Missoula, Montana, United States
• Study site — Bellevue, Nebraska, United States
• Study site — Fremont, Nebraska, United States
• Study site — Omaha, Nebraska, United States
• Study site — Ocean Township, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Rolling Hills Estates, California, United States

Full record on ClinicalTrials.gov

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