Phase III Cat-PAD Study

Circassia Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Rhinoconjunctivitis

Treatments: Drug: Placebo; Drug: Cat-PAD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01620762

CP007

Details and patient eligibility

About

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.

Enrollment: 1,408 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,408 participants in 3 patient groups, including a placebo group

Cat-Pad Treatment 1

Experimental group

Description:

Cat-PAD Treatment 1

Treatment:

Drug: Cat-PAD

Cat-PAD Treatment 2

Experimental group

Description:

Cat-PAD Treatment regimen 2

Treatment:

Drug: Cat-PAD

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo