Paediatric Safety Study in Cat-PAD
Study Details
Study Description
Brief Summary
Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Cat-PAD and Placebo |
Drug: Cat-PAD
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With AEs [up to 36 weeks after start of treatment]
To evaluate the safety and tolerability of Cat-PAD in paediatric subjects aged 5 to <12 years.
Eligibility Criteria
Criteria
-
Inclusion Criteria
-
Male or female, aged 5-12 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 relevant abnormalities detected on physical examination.
-
History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lodz | Poland | |||
| 2 | Tarnow | Poland | |||
| 3 | Warsaw | Poland |
Sponsors and Collaborators
- Circassia Limited
- inVentiv Health Clinical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP009
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo run-in Followed by Cat-PAD |
|---|---|
| Arm/Group Description | All participants; received two intradermal doses of placebo (saline) followed by eight intradermal administrations of Cat-PAD. |
| Period Title: Overall Study | |
| STARTED | 16 |
| Placebo run-in | 16 |
| Active Treatment | 13 |
| COMPLETED | 13 |
| NOT COMPLETED | 3 |
Baseline Characteristics
| Arm/Group Title | Study Participants |
|---|---|
| Arm/Group Description | Overall study participants |
| Overall Participants | 16 |
| Age (Count of Participants) | |
| <=18 years |
16
100%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
6
37.5%
|
| Male |
10
62.5%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
16
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| Poland |
16
100%
|
Outcome Measures
| Title | Number of Subjects With AEs |
|---|---|
| Description | To evaluate the safety and tolerability of Cat-PAD in paediatric subjects aged 5 to <12 years. |
| Time Frame | up to 36 weeks after start of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| All subjects enrolled |
| Arm/Group Title | Study Participants |
|---|---|
| Arm/Group Description | Overall study participants |
| Measure Participants | 16 |
| Adverse Events Placebo |
5
31.3%
|
| Adverse Events Cat-PAD |
12
75%
|
Adverse Events
| Time Frame | Overall study (up to 36 weeks after the start of treatment) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Placebo run-in | Cat-PAD | ||
| Arm/Group Description | Placebo run-in | Active treatment (Cat-PAD) | ||
All Cause Mortality |
||||
| Placebo run-in | Cat-PAD | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Placebo run-in | Cat-PAD | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/16 (0%) | 2/16 (12.5%) | ||
| Infections and infestations | ||||
| pneumonia | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Clavicle fracture | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Placebo run-in | Cat-PAD | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/16 (31.3%) | 12/16 (75%) | ||
| Gastrointestinal disorders | ||||
| Dyspepsia | 1/16 (6.3%) | 1 | 1/16 (6.3%) | 1 |
| Vomiting | 1/16 (6.3%) | 1 | 0/16 (0%) | 0 |
| Immune system disorders | ||||
| Allergy to animal | 0/16 (0%) | 0 | 1/16 (6.3%) | 2 |
| Infections and infestations | ||||
| Pharyngitis | 1/16 (6.3%) | 1 | 5/16 (31.3%) | 8 |
| Bronchitis | 0/16 (0%) | 0 | 2/16 (12.5%) | 2 |
| Laryngitis | 0/16 (0%) | 0 | 2/16 (12.5%) | 2 |
| Tonsillitis | 0/16 (0%) | 0 | 2/16 (12.5%) | 2 |
| Nasopharyngitis | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 |
| Otitis media | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 |
| Gastroenteritis viral | 1/16 (6.3%) | 1 | 0/16 (0%) | 0 |
| Pneumonia | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Clavicle fracture | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 |
| Nervous system disorders | ||||
| Headache | 0/16 (0%) | 0 | 1/16 (6.3%) | 7 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 1/16 (6.3%) | 1 | 1/16 (6.3%) | 1 |
| rhinorrhea | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
To avoid disclosures that may affect the proprietary rights of the Sponsor, the Investigator agrees to allow Circassia the opportunity to review all manuscripts and abstracts 60 days prior to submission for publication. Circassia reserves the right to include the report of this study in any regulatory documentation or submission or in any informational materials.
Results Point of Contact
| Name/Title | VP Clinical Operations |
|---|---|
| Organization | Circassia Ltd |
| Phone | +44 1864 405560 |
- CP009