Cat AllergyPhase 1/2NCT00685711
Safety of Cat-PAD in Cat Allergic Subjects
A Phase 1/2 study testing Cat-PAD in people with Cat Allergy, run by Circassia Limited at 1 site in Germany.
Trial summary
Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cat Allergy
- What is being tested?
- Cat-PAD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Jul 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A reliable history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) or controlled asthma (GINA (2006) classification 1) on exposure to cats for at least 1 year.
- 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 on single arm.
Who cannot join
- Subjects with asthma falling under GINA(2006) classification 2 (partly controlled) and 3 (uncontrolled).
- A history of anaphylaxis to cat allergen.
- Subjects with a cat specific IgE >100 kU/L.
- Subjects with an FEV1 <80% of normal.
- Subjects with an acute phase skin response to cat allergen with a weal diameter > 30mm.
- Subjects who suffer from hay fever, and cannot complete the clinical study outside the pollen season.
Show all 10Show fewer
- Allergen immunotherapy during the last 5 years or Cat Dander immunotherapy ever.
- 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.
- Subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
- Subjects being treated with beta-blockers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Escalating Single Intradermal or Subcutaneous Dose Study in Cat Allergic Subjects to Assess the Safety of Cat-PAD.
Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy. This study will investigate the safety of Cat-PAD administered as increasing single doses.
Read the detailed description
This study is designed as a two centre, randomised, placebo-controlled, escalating single dose study in up to 88 cat allergic subjects. Cohorts of 8 subjects will be enrolled. Each cohort will undergo screening 14-28 days before treatment and a baseline challenge for EPSR and LPSR to cat allergen injected into the arm 7 days before treatment. On the treatment day, subjects will be injected either intradermally (into the skin) or subcutaneously (under the skin) with a single dose of Cat-PAD or placebo and safety observations made for 8 h. After 21 days, subjects will again have cat allergen injected into the arm and the EPSR and LPSR will be recorded. The dose of Cat-PAD will be increased in successive cohorts, provided that the previous dose tested was well tolerated.
- Conditions
- Cat Allergy
- Being tested
- Cat-PAD
- Keywords
- Cat allergy, Immunotherapy, Cat-PAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cat-PADBiological
single, escalating dose intradermal and subcutaneous injections of Cat-PAD
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo intradermal n = 2 with each dose level of Cat-PAD. Receives: Biological: Cat-PAD |
| 2 | Experimental | Intradermal injection of increasing single doses of Cat-PAD (0.03, 0.3, 3, 12 nmol) n = 6 per dose level. Based on review of blinded LPSR, an additional dose of Cat-PAD between 0.03 and 12 nmol may be administered to an additional cohort of 6 subjects. Receives: Biological: Cat-PAD |
| 3 | Placebo comparator | Placebo subcutaneous n = 2 with each dose level of Cat-PAD. Receives: Biological: Cat-PAD |
| 4 | Experimental | Subcutaneous injection of increasing single doses of Cat-PAD (0.03, 0.3, 3, 12, 20 nmol) n = 6 per dose level. Based on review of blinded LPSR, an additional dose of Cat-PAD between 0.03 and 20 nmol may be administered to an additional cohort of 6 subjects. Receives: Biological: Cat-PAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of Cat-PAD
Measured: 0, 7, 21 days
Secondary outcomes (1)
Late-Phase Skin Reaction (LPSR) 8 hours after intradermal challenge with whole cat allergen.
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cat AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Margitta Worm, MD Professor, Principal investigator, Allergy-Centre-Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685711
- Sponsor's protocol ID
- CP001
- Status last verified
- Aug 2008
- First submitted
- 20 May 2008
- Last updated
- 6 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Escalating Single Intradermal or Subcutaneous Dose Study in Cat Allergic Subjects to Assess the Safety of Cat-PAD.
- ClinicalTrials.gov ID
- NCT00685711
- Acronym / sponsor ID
- CP001
- Conditions
- Cat Allergy
- Keywords
- Cat allergy, Immunotherapy, Cat-PAD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 28 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy. This study will investigate the safety of Cat-PAD administered as increasing single doses.
Detailed description
This study is designed as a two centre, randomised, placebo-controlled, escalating single dose study in up to 88 cat allergic subjects. Cohorts of 8 subjects will be enrolled. Each cohort will undergo screening 14-28 days before treatment and a baseline challenge for EPSR and LPSR to cat allergen injected into the arm 7 days before treatment. On the treatment day, subjects will be injected either intradermally (into the skin) or subcutaneously (under the skin) with a single dose of Cat-PAD or placebo and safety observations made for 8 h. After 21 days, subjects will again have cat allergen injected into the arm and the EPSR and LPSR will be recorded. The dose of Cat-PAD will be increased in successive cohorts, provided that the previous dose tested was well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Biological: Cat-PADPlacebo intradermal n = 2 with each dose level of Cat-PAD. |
| 2 | Experimental | Biological: Cat-PADIntradermal injection of increasing single doses of Cat-PAD (0.03, 0.3, 3, 12 nmol) n = 6 per dose level. Based on review of blinded LPSR, an additional dose of Cat-PAD between 0.03 and 12 nmol may be administered to an additional cohort of 6 subjects. |
| 3 | Placebo comparator | Biological: Cat-PADPlacebo subcutaneous n = 2 with each dose level of Cat-PAD. |
| 4 | Experimental | Biological: Cat-PADSubcutaneous injection of increasing single doses of Cat-PAD (0.03, 0.3, 3, 12, 20 nmol) n = 6 per dose level. Based on review of blinded LPSR, an additional dose of Cat-PAD between 0.03 and 20 nmol may be administered to an additional cohort of 6 subjects. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A reliable history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) or controlled asthma (GINA (2006) classification 1) on exposure to cats for at least 1 year.
- 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 on single arm.
Key exclusion criteria (10 listed)
- Subjects with asthma falling under GINA(2006) classification 2 (partly controlled) and 3 (uncontrolled).
- A history of anaphylaxis to cat allergen.
- Subjects with a cat specific IgE >100 kU/L.
- Subjects with an FEV1 <80% of normal.
- Subjects with an acute phase skin response to cat allergen with a weal diameter > 30mm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cat-PADsingle, escalating dose intradermal and subcutaneous injections of Cat-PAD | Biological | 1, 2, 3, 4 |
Primary outcome
Safety and tolerability of Cat-PAD
Time frame: 0, 7, 21 days
1 secondary outcome
Late-Phase Skin Reaction (LPSR) 8 hours after intradermal challenge with whole cat allergen.
Time frame: Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margitta Worm, MD Professor principal investigator
Allergy-Centre-Charité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cat-PAD in people with Cat Allergy, run by Circassia Limited at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of Cat-PAD (time frame: 0, 7, 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2008.