Cat allergic rhinistis and asthma MedDRA version: 9.1 Level: LLT Classification code 10034382 Term: Perennial allergic rhinitis MedDRA version: 9.1 Level: LLT Classification code 10001705 Term: Allergic asthma
Conditions
Interventions
Product Name: Cat-PAD
Product Code: MLA01 acetate
Pharmaceutical Form: Injection*
INN or Proposed INN: H-Cys-Pro-Ala-Val-Lys-Arg-Asp-Val-Asp-Leu-Phe-Leu-Thr-OH, acetate salt
Current Sponsor code: MLA0
Sponsors
Circassia Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Male or female, aged 18-65 years. 2. A reliable history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) or controlled asthma (GINA (2006) classification 1, see Appendix 3) on exposure to cats for at least 1 year. 3. Subjects who provide written informed consent. 4. Positive skin prick test to Leti cat allergen with a weal diameter at least 3mm larger than that produced by the negative control. 5. Late-Phase Allergic Skin Reaction (LPSR) to 0.010 HEP units Leti cat allergen eight hours after intradermal injection of greater than 25mm diameter response for the mean of both arms. 6. The subject must be willing and able to comply with the study requirements as described in this protocol (and its amendments, if any). 7. If the subject is female and of childbearing potential she must practice an acceptable form of contraception (oral contraceptives, injectable or implantable methods, intra-uterine devices, sexual abstinence or a vasectomised partner), and produce a negative urine pregnancy test on the Screening Visit. A female subject may be included without a negative urine pregnancy test if she can document that she is surgically sterile or at least 2 years post-menopausal. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Subjects with asthma falling under GINA(2006) classification 2 (partly controlled) and 3 (uncontrolled) (see Appendix 3). 2. A history of anaphylaxis to cat allergen. 3. Subjects with a cat specific IgE >100 kU/L. 4. Subjects with an FEV1 30mm. 6. Subjects who suffer from hay fever, and cannot complete the clinical study outside the pollen season. 7. Allergen immunotherapy during the last 5 years or Cat Dander immunotherapy ever. 8. Subjects who have completed or are undergoing ongoing treatment with anti-IgE-antibody. 9. Use of the following therapies for the periods specified prior to the screening visit will make the subject ineligible for the study: corticosteroids: (depot: 90 days; systemic: 30 days; dermatological, intranasal, inhalational: 15 days); cromones (14 days); antihistamines other than loratadine (nasal and long-acting oral: 10 days; short-acting oral, ocular: 7 days); leukotriene inhibitors (10 days); anticholinergics (7 days); alpha-adrenergic agonists (7 days); tricyclic antidepressants (14 days). If it becomes a medical necessity for a subject to use one of these contraindicated medications during the study this will become an individual stopping criteria. 10. Subjects who do not respond to loratadine. 11. The subject has unacceptable symptoms in the 3 days without loratadine prior to the screening visit. 12. Subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension). 13. Subjects being treated with beta-blockers. 14. Subjects who have completed or are undergoing ongoing treatment with tranquillizers or psychoactive drugs. 15. Have symptoms of a clinically relevant illness, including urticaria factitia, in the Investigator’s opinion, within 6 weeks prior to Screening Visit. 16. Female subjects who are pregnant, lactating or planning a pregnancy during the study. 17. Have any clinically relevant abnormalities detected on physical examination. 18. 12-lead ECG or vital signs (blood pressure, pulse rate, respiratory rate and oral temperature) that are outside normal limits, unless the abnormality is considered not to be of clinical relevance by the Investigator. 19. Laboratory values (haematology, biochemistry, urine tests) that are outside the normal ranges, unless the abnormality is considered not to be of clinical relevance by the Investigator. 20. Significant history of alcohol or drug abuse. 21. History of hepatitis B, hepatitis C or HIV. 22. Have previously been randomised into this study or have received Cat-PAD (or a prototype thereof) previously. 23. Have a history of severe drug allergy or anaphylactic reaction to food. 24. Planned travel outside the study area for a substantial portion of the study period. 25. Have received treatment with an investigational drug within 6 months prior to study screening or have participated in a study with a new formulation of a marketed drug one month prior to study screening. 26. Any subject deemed by the Investigator to have questionable reliability in their ability to comply with the protocol and provide accurate information. 27. Are unable to communicate or to understand the requirements of the study, or any psychiatric disorder, which would impair communication between the subject and the Investigator thereby interfering with the informed cons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of single, escalating dose, intradermal and subcutaneous injections of Cat-PAD in cat allergic subjects.;Secondary Objective: 1. To evaluate the relationship between the dose of Cat-PAD (given intradermally or subcutaneously) and the late-phase skin response (LPSR) to whole cat allergen in order to identify the optimal immunologically effective dose for subsequent studies. 2. To evaluate the dose response relationship of the effect of single intradermal and subcutaneous injections of Cat-PAD on the early phase skin response (EPSR) to whole cat allergen. ;Primary end point(s): PRIMARY EFFICACY ENDPOINT The mean diameter of the Late-Phase Skin Reaction (LPSR) 8 hours after intradermal challenge with whole cat allergen on Treatment Phase Visit 2 (Day 21) after Cat-PAD injection compared to the mean diameter of the LPSR at the Baseline Visit in per-protocol subjects. SAFETY ENDPOINTS Safety and tolerability will be assessed by the following: • Adverse events • Physical examination • Vital signs • Electrocardiogram • Laboratory values (haematology, serum biochemistry, urine tests) • Spirometry FEV1 • Subjective score of breathlessness • Subjective score of nasal symptoms • Local reactions at the injection site | — |
Countries
Germany
Outcome results
None listed