Paediatric Safety Study in Cat-PAD

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01921257
• Date of registration: 17/07/2013
• Prospective Registration: Yes
• Primary sponsor: Circassia Limited
• Public title: Paediatric Safety Study in Cat-PAD
• Scientific title: A Multi-Centre, Single-Blind Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects
• Date of first enrolment: August 2013
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01921257
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Single (Care Provider).
• Phase: Phase 2

Countries of recruitment

Poland, United States

Key inclusion & exclusion 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.



Age minimum: 5 Years
Age maximum: 11 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rhinoconjunctivitis

Intervention(s)

Drug: Placebo

Drug: Cat-PAD

Primary Outcome(s)

Number of Subjects With AEs [Time Frame: up to 36 weeks after start of treatment]

Secondary ID(s)

CP009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

inVentiv Health Clinical

Results

• Results available: Yes
• Date Posted: 17/04/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01921257