Phase 3
N=430
Phase III Cat-PAD Follow-on Study
Cat Allergy
Bottom Line
View on ClinicalTrials.gov: NCT02040844 ↗Enrolled (actual)
430
Serious AEs
2.3%
Results posted
May 2018
Primary outcome: Primary: Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS]) — 1.99; 1.91; 1.93 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 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] (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Circassia Limited
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS]) |
1.99; 1.91; 1.93 | — |
| SECONDARY Mean TRSS |
12.95; 13.15; 12.92 | — |
| SECONDARY Mean Component Scores of the TRSS (Nasal) |
7.06; 7.17; 6.96 | — |
| SECONDARY Mean Component Scores of the TRSS (Ocular) |
5.90; 5.97; 6.00 | — |
| SECONDARY Mean Allergy Medication Score (AMS) |
0.37; 0.27; 0.31 | — |
| SECONDARY Mean RQLQ Score |
1.58; 1.62; 1.51 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02040844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.