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

Phase 1

Conditions: Treatment of cat allergen induced rhinoconjunctivitis in patients with clinically relevant symptoms
MedDRA version: 14.1Level: LLTClassification code 10034382Term: Perennial allergic rhinitisSystem Organ Class: 100000004855
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2012-001733-13-HU

Lead Sponsor: Circassia Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1182

Inclusion Criteria

1. Male or female, aged 12-65 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 optionally also have GINA Step 1 controlled asthma.
3. Subjects who live in a home with a cat that spends, on average, a minimum of 8 hours per day inside.
4. Subjects must have a mean TRSS =10 from 4 nasal symptoms and 4 ocular symptoms during the Baseline Allergy Evaluation period (3-week period before randomisation) based on at least 17 days of eDiary completion.
5. Positive skin prick test to e.g. ALK Abello cat hair with a wheal diameter at least 5 mm larger than that produced by the negative control.
6. Subjects must have a cat dander specific IgE =0.35 kU/L by ImmunoCAP®.
Are the trial subjects under 18? yes
Number of subjects for this age range: 236
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 946
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Subjects with asthma falling under the GINA definitions partly controlled” and uncontrolled” or Steps 2 to 5.
2. Subjects who use any other category of allergy medications beyond those specified in the Rescue Medication Package during the Baseline Allergy Evaluation Period.
3. Subjects with a FEV1 <80% of predicted.
4. Subjects who intend to stop keeping a cat living indoors for, on average, a minimum of 8 hours per day in the following year.
5. Subjects who intend to be away for 7 days or more during the final PAC period at 52-54 weeks (PAC3), or whose lifestyle means that there is a high likelihood of them being away from home for more than 7 days during the PAC3 period.
6. Subjects with clinically significant confounding symptoms of allergy to other seasonal allergens (e.g.ragweed, mugwort, tree, grass or mould) and cannot complete the Baseline and the final PAC period at 52-54 weeks (PAC3) outside the respective allergy seasons.
7. Subjects who have a skin prick test 5 mm greater than the negative control to perennial allergens (e.g. house dust mite, cockroach, mould) enrolled at a location where conditions remain conducive to the growth
of these organisms during the Baseline and the final PAC period at 52-54
weeks (PAC3).
8. Subjects who have a skin prick test 5 mm greater than the negative control to animal dander (other than cat) which cannot be avoided during the study.
9. Subjects who are pregnant, lactating or planning to become pregnant, or donate ova for in vitro fertilisation during the study period or within 30 days following the study period. Female subjects unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur either during or for 30 days following the completion of study period.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of the novel desensitising immunotherapy Cat-PAD in the reduction of symptoms and the use of allergy rescue medication associated with cat allergy in subjects with clinically relevant symptoms.;Secondary Objective: To evaluate the safety and tolerability of administration of the novel desensitising immunotherapy Cat-PAD. <br>To evaluate the effect of the novel desensitising immunotherapy Cat-PAD on RQLQ. <br>To evaluate the relative efficacy, safety and tolerability of two dosing regimens of Cat-PAD in subjects with clinically relevant symptoms.;Primary end point(s): The mean Combined Score in the Cat-PAD treatment groups compared with the mean Combined Score in the placebo group.;Timepoint(s) of evaluation of this end point: Weeks 52-54 after randomisation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Mean TRSS in Cat-PAD treatment groups compared with placebo.<br>- Mean component scores of the TRSS (nasal and ocular) in Cat-PAD treatment groups compared with placebo.<br>- Mean RMS in Cat-PAD treatment groups compared with placebo.<br>- Mean RQLQ score in Cat-PAD treatment groups compared with placebo.<br>- Number of days subjects have no moderate or severe TRSS symptoms without rescue medication usage.;Timepoint(s) of evaluation of this end point: Weeks 52-54 after randomisation

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