A study to investigate the safety of Cat-PAD in children who are allergic to cats.

• Register: EUCTR
• Last refreshed on: 1 February 2016
• Main ID: EUCTR2014-000279-15-PL
• Date of registration: 21/05/2014
• Prospective Registration: Yes
• Primary sponsor: Circassia Limited
• Public title: A study to investigate the safety of Cat-PAD in children who are allergic to cats.
• Scientific title: A Multi-Centre, Single-Blind Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects.
• Date of first enrolment: 03/07/2014
• Target sample size: 18
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000279-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: yes Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: placebo run-in If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Poland

Contacts

• Name: CP009-ClinicalTrialInformation-Desk
• Affiliation: Circassia Limited

• Name: CP009-ClinicalTrialInformation-Desk
• Affiliation: Circassia Limited

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female, aged 5 to <12 years.
2. A reliable history consistent with moderate to severe rhinoconjunctivitis (sneezing, rhinorrhoea, itchy nose, nasal blockage and/or itchy eyes, red eyes, sore eyes, watering eyes) on exposure to cats for at least 2 years and which has required symptomatic treatment on at least one occasion during the last year.
- Subjects may also have asthma controlled using reliever medication as defined in GINA.
3. Subjects who live in a home with a cat that spends, on average, a minimum of 8 hours per day inside.
4. Positive skin prick test to cat hair allergen with a wheal diameter (mean of longest and orthogonal diameter) at least 5 mm larger than that produced by the negative control.
5. A cat dander specific Immunoglobulin E (IgE) =0.35 kU/L.

Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Subjects with a history of severe drug allergy, severe angiodema or anaphylactic reaction to food.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Treatment of cat-allergen induced rhinoconjunctivitis in paediatric subjects with clinically relevant symptoms
MedDRA version: 18.0 Level: LLT Classification code 10034382 Term: Perennial allergic rhinitis System Organ Class: 100000004855

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Name: Cat-PAD
Product Code: Not Applicable
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: See section D.3.9.6
CAS Number: Not assigned
Current Sponsor code: MLA01
Other descriptive name: MLA01
Concentration unit: nmol nanomole(s)
Concentration type: equal
Concentration number: 6-
INN or Proposed INN: See Section D.3.9.6
CAS Number: Not assigned
Current Sponsor code: MLA03
Other descriptive name: MLA03
Concentration unit: nmol nanomole(s)
Concentration type: equal
Concentration number: 6-
INN or Proposed INN: See section D.3.9.6
CAS Number: Not assigned
Current Sponsor code: MLA04
Other descriptive name: MLA04
Concentration unit: nmol nanomole(s)
Concentration type: equal
Concentration number: 6-
INN or Proposed INN: See section D.3.9.6
CAS Number: Not assigned
Current Sponsor code: MLA05
Other descriptive name: MLA05
Concentration unit: nmol nanomole(s)
Concentration type: equal
Concentration number: 6-
INN or Proposed INN: See section D.3.9.6
CAS Number: Not assigned
Current Sponsor code: MLA07
Other descriptive name: MLA07
Concentration unit: nmol nanomole(s)
Concentration type: equal
Concentration number: 6-
INN or Proposed INN: See section D.3.6.9
CAS Number: Not assigned
Current Sponsor code: MLA12
Other descriptive name: MLA12
Concentration unit: nmol nanomole(s)
Concentration type: equal
Concentration number: 6-
INN or Proposed INN: See Section D.3.9.6
CAS Number: Not assigned
Current Sponsor code: MLA14
Other descriptive name: MLA14
Concentration unit: nmol nanomole(s)
Concentration type: equal
Concentration number: 6-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intradermal use

Primary Outcome(s)

Main Objective: To evaluate the safety and tolerability of Cat-PAD in paediatric subjects aged 5 to <12 years.

Secondary Objective: To explore the efficacy of Cat-PAD in the reduction of rhinoconjunctivitis symptoms associated with cat allergy in paediatric subjects with clinically relevant symptoms.
To explore the Impression of Change in Health as evaluated by subjects, their parents/legal guardians and the Investigator.

Primary end point(s): Proportion and frequency of Adverse Events (AEs) and local reactions at the Cat-PAD injection site 2 to 4 weeks after the last Cat-PAD administration compared with the proportion and frequency of AEs and local reactions during the placebo run-in.

Timepoint(s) of evaluation of this end point: During the placebo run-in and 2 to 4 weeks after the last CAT-PAD administration.

Secondary Outcome(s)

Secondary end point(s): • Pain on administration of Cat-PAD compared with placebo measured using the Wong-Baker FACES pain scale.
• Other secondary safety endpoints will be based on safety assessments including physical examination, vital signs, laboratory values (haematology, serum biochemistry, urine tests), PEF, and assessment of breathlessness.

Timepoint(s) of evaluation of this end point: • Pain on administration of Cat-PAD compared with placebo measured using the Wong-Baker FACES pain scale. - Run-In and Study Medication Administration phases
• Other secondary safety endpoints will be based on safety assessments including physical examination, vital signs, laboratory values (haematology, serum biochemistry, urine tests), PEF, and assessment of breathlessness. - thoughout the study duration.

Secondary ID(s)

CP009

NCT01921257

Source(s) of Monetary Support

Circassia Limited