Phase III Cat-PAD Follow-on Study

• ClinicalTrials.gov Identifier: NCT02040844
• Recruitment Status: Completed
• First Posted: January 20, 2014
• Results First Posted: May 14, 2018
• Last Update Posted: June 15, 2018
• Sponsor: Circassia Limited
• Information provided by (Responsible Party): Circassia Limited

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cat Allergy	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]	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 430 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: An Optional Prospective Follow-on Study to Evaluate the Continued Efficacy and Safety of Cat-PAD in Cat Allergic Subjects up to Five Years After the Administration of Treatment
• Actual Study Start Date: February 2014
• Actual Primary Completion Date: May 2017
• Actual Study Completion Date: May 2017

Arms and Interventions

Arm	Intervention/treatment
Cat-PAD Treatment 1; Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762].No further treatment received in CP007A	Drug: Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]
Cat-PAD Treatment 2; Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762].No further treatment received in CP007A.	Drug: Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]
Cat-PAD Treatment 3; Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]. No further treatment received in CP007A.	Drug: Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]

Outcome Measures

Primary Outcome Measures :

1. Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS]) [ Time Frame: 1 year after completing CP007 ]

   The primary endpoint was the mean Combined Score (CS) in Cat-PAD treatment groups compared with the mean CS in the placebo group. This was assessed one year after completing the original study (CP007).

   CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Allergy Medication Score (AMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe) and the TRSS was divided by the number of symptoms to provide an average score per symptom of 0-3.

   AMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The AMS score was not additive, and therefore the maximum AMS was 3 and the maximum CS was 6.

Secondary Outcome Measures :

1. Mean TRSS [ Time Frame: 1 year after completion of CP007 ]

   Mean Total Rhinoconjunctivitis Symptom Score (TRSS) in Cat-PAD treatment groups compared with placebo.

   Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome), therefore TRSS could range from 0 to 24. Higher TRSS reflected more severe symptom scores. Symptoms were scored daily for a period of approximately 3 weeks one year after completing the first study (CP007).

2. Mean Component Scores of the TRSS (Nasal) [ Time Frame: 1 year after completion of CP007 ]

   TNSS (Total nasal symptom score) was the sum of all the nasal symptom scores (runny nose; sneezing; blocked nose; itchy nose) and could range from 0 to 12. Higher TNSS reflected more severe symptoms.

   Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks 1 year after completing the original CP007 study.

3. Mean Component Scores of the TRSS (Ocular) [ Time Frame: 1 year after completion of CP007 ]

   Mean daily Total Ocular Symptom Score (TOSS) in Cat-PAD treatment groups compared to placebo groups

   Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. TOSS was the sum of all the ocular symptom scores (itchy eyes; watery eyes; red eyes; sore eyes) and could range from 0 to 12. Higher TOSS reflected more severe symptoms.

   Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks one year after completing the original CP007 study

4. Mean Allergy Medication Score (AMS) [ Time Frame: 1 year after completion of CP007 ]

   Mean AMS (Allergy medication score) in Cat-PAD treatment groups compared with placebo groups.

   The use of rhinoconjunctivitis rescue medications was recorded by the subject for a period of 21 days, on a daily basis just before bedtime, approximately 1 year after completing the original CP007 study. Rescue medication use was scored based on a previously published system as follows: 0 = no allergy rescue medication used per day; 0.5 = at least one dose of antihistamine eye drops used per day; 1 = at least one dose of oral antihistamine used per day; 2 = at least one dose of intranasal corticosteroid used per day; 3 = at least one dose of systemic corticosteroid used per day. The score was according to the highest level of rescue medication used and was not additive.

5. Mean RQLQ Score [ Time Frame: 1 year after completion of CP007 ]

   The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects one year after the completion of the previous study (CP007).

   The RQLQ is a validated method of assessing quality of life and has 28 questions in seven domains (activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems and emotional function). Subjects recalled how their rhinoconjunctivitis had been during the last week and responded to each question on a seven-point scale (0 = no impairment, 6 = maximum impairment). The questions were equally weighted, and the RQLQ score was the mean of the 28 questions and could range from zero to six.

   A higher score indicated greater impact on quality of life and thus a low score indicated a better outcome.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• previously completed clinical study CP007 [NCT01620762]

Exclusion Criteria:

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

Contacts and Locations

Sponsors and Collaborators

Circassia Limited

Investigators

• Principal Investigator: Jörg Kleine-Tebbe, MD; Clinical Research Center for Dermatology, Allergy & Asthma

  Study Documents (Full-Text)

Documents provided by Circassia Limited:

Study Protocol  [PDF] December 8, 2014

Statistical Analysis Plan  [PDF] February 23, 2017

More Information

• Responsible Party: Circassia Limited
• ClinicalTrials.gov Identifier: NCT02040844
• Other Study ID Numbers: CP007 A
• First Posted: January 20, 2014
• Results First Posted: May 14, 2018
• Last Update Posted: June 15, 2018
• Last Verified: May 2018