NCT02040844

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
430

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2014

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
1 year until next milestone

Results Posted

Study results publicly available

May 14, 2018

Completed
Last Updated

June 15, 2018

Status Verified

May 1, 2018

Enrollment Period

3.2 years

First QC Date

January 17, 2014

Results QC Date

April 18, 2018

Last Update Submit

May 16, 2018

Conditions

Cat Allergy

Outcome Measures

Primary Outcomes (1)

  • Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS])

    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.

    1 year after completing CP007

Secondary Outcomes (5)

  • Mean TRSS

    1 year after completion of CP007

  • Mean Component Scores of the TRSS (Nasal)

    1 year after completion of CP007

  • Mean Component Scores of the TRSS (Ocular)

    1 year after completion of CP007

  • Mean Allergy Medication Score (AMS)

    1 year after completion of CP007

  • Mean RQLQ Score

    1 year after completion of CP007

Study Arms (3)

Cat-PAD Treatment 1

OTHER

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

OTHER

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

OTHER

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]

Interventions

Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]DRUG
Cat-PAD Treatment 1
Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]DRUG
Cat-PAD Treatment 2
Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]DRUG
Cat-PAD Treatment 3

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • previously completed clinical study CP007 \[NCT01620762\]

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Results Point of Contact

Title
VP Clinical Operations
Organization
Circassia Ltd
info@circassia.com
+44 1865 405560

Study Officials

  • Jörg Kleine-Tebbe, MD

    Clinical Research Center for Dermatology, Allergy & Asthma

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2014

First Posted

January 20, 2014

Study Start

February 1, 2014

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

June 15, 2018

Results First Posted

May 14, 2018

Record last verified: 2018-05