Phase III Cat-PAD Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01620762
• Date of registration: 30/05/2012
• Prospective Registration: Yes
• Primary sponsor: Circassia Limited
• Public title: Phase III Cat-PAD Study
• Scientific title: A Double-Blind, Randomised, Placebo-Controlled Multi-Centre Field Study to Assess the Efficacy and Safety of Cat-PAD Peptide Immunotherapy in Cat Allergic Subjects
• Date of first enrolment: October 2012
• Target sample size: 1408
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01620762
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, Czech Republic, Czechia, Germany, Hungary, Poland, Russian Federation, Slovakia, United States

Contacts

• Name: Harold Nelson, MD
• Affiliation: Jewish National Health

Key inclusion & exclusion 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.



Age minimum: 12 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rhinoconjunctivitis

Intervention(s)

Drug: Cat-PAD

Drug: Placebo

Primary Outcome(s)

Mean Combined Score in Cat-PAD Treatment Groups Compared With Placebo [Time Frame: 52-54 weeks after randomisation]

Secondary Outcome(s)

Mean Daily TOSS in Cat-PAD Compared to Placebo [Time Frame: 52-54 weeks after randomisation]

Mean RQLQ Score in Cat-PAD Compared With Placebo [Time Frame: 52-54 weeks after randomisation]

Number of Days With no Moderate or Severe TRSS Symptoms Without Rescue Medication Use [Time Frame: 52-54 week after randomisaiton]

Mean Daily TNSS in Cat-PAD Compared With Placebo [Time Frame: 52-54 weeks after randomisation]

Mean TRSS [Time Frame: 52-54 weeks after randomisation]

Mean RMS in Cat-PAD Compared With Placebo [Time Frame: 52-54 weeks after randomisation]

Secondary ID(s)

CP007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pharm-Olam International

inVentiv Health Clinical

Results

• Results available: Yes
• Date Posted: 14/05/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01620762