Phase III Cat-PAD Follow-on Study

Circassia Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Cat Allergy

Treatments: Drug: Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]; Drug: Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]; Drug: Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]

Study type: Interventional

Funder types: Industry

Identifiers

NCT02040844

CP007 A

Details and patient eligibility

About

The purpose of this study is to evaluate the continued effectiveness and safety of Cat-PAD in cat allergic subjects for up to five years after the start of administration of treatment. The study is an optional follow-up study to a phase III double-blind, placebo controlled, Cat-PAD study; no further investigational product is administered.

Enrollment: 430 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• previously completed clinical study CP007 [NCT01620762]

Exclusion criteria

• started allergen therapy since completing CP007
• Institutionalised due to a legal or regulatory order

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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430 participants in 3 patient groups

Cat-PAD Treatment 1

Other group

Description:

Received Cat-PAD Treatment 1 in Study CP007 \[NCT01620762\].No further treatment received in CP007A

Treatment:

Drug: Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]

Cat-PAD Treatment 2

Other group

Description:

Received Cat-PAD Treatment 2 in Study CP007 \[NCT01620762\].No further treatment received in CP007A.

Treatment:

Drug: Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]

Cat-PAD Treatment 3

Other group

Description:

Received Cat-PAD Treatment 3 in Study CP007 \[NCT01620762\]. No further treatment received in CP007A.

Treatment:

Drug: Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]