Phase 3
N=1,408
Phase III Cat-PAD Study
Rhinoconjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT01620762 ↗Enrolled (actual)
1,408
Serious AEs
2.4%
Results posted
May 2018
Primary outcome: Primary: Mean Combined Score in Cat-PAD Treatment Groups Compared With Placebo — 1.04; 1.00; 1.05 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cat-PAD (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Circassia Limited
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Combined Score in Cat-PAD Treatment Groups Compared With Placebo |
1.04; 1.00; 1.05 | — |
| SECONDARY Mean TRSS |
5.67; 5.54; 5.87 | — |
| SECONDARY Mean Daily TNSS in Cat-PAD Compared With Placebo |
3.48; 3.36; 3.44 | — |
| SECONDARY Mean Daily TOSS in Cat-PAD Compared to Placebo |
2.20; 2.19; 2.42 | — |
| SECONDARY Mean RMS in Cat-PAD Compared With Placebo |
0.34; 0.31; 0.32 | — |
| SECONDARY Mean RQLQ Score in Cat-PAD Compared With Placebo |
1.26; 1.26; 1.25 | — |
| SECONDARY Number of Days With no Moderate or Severe TRSS Symptoms Without Rescue Medication Use |
9.44; 10.11; 9.76 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01620762). 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.