Phase 2
N=16
Paediatric Safety Study in Cat-PAD
Rhinoconjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT01921257 ↗Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Apr 2018
Primary outcome: Primary: Number of Subjects With AEs — 5; 12 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cat-PAD (Drug); Placebo (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Circassia Limited
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With AEs |
5; 12 | — |
Summary
Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects
Eligibility Criteria
- Inclusion Criteria
- Male or female, aged 5-12 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 relevant abnormalities detected on physical examination.
- History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
Data sourced from ClinicalTrials.gov (NCT01921257). 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.