Rhinoconjunctivitis
Conditions
Keywords
Cat Allergy, Rhinoconjunctivitis
Brief summary
Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects
Interventions
DRUGCat-PAD
DRUGPlacebo
Sponsors
inVentiv Health Clinical
Circassia Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Participants Overall study participants | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Study Participants |
|---|---|
| Age, Categorical <=18 years | 16 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment Poland | 16 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 16 | 12 / 16 |
| serious Total, serious adverse events | 0 / 16 | 2 / 16 |
Outcome results
Primary
Number of Subjects With AEs
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
Population: All subjects enrolled
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Number of Subjects With AEs | Adverse Events Placebo | 5 participants |
| Study Participants | Number of Subjects With AEs | Adverse Events Cat-PAD | 12 participants |