Trial Outcomes & Findings for Paediatric Safety Study in Cat-PAD (NCT NCT01921257)

Last Updated: 2018-05-14

Results Overview

To evaluate the safety and tolerability of Cat-PAD in paediatric subjects aged 5 to \<12 years.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

up to 36 weeks after start of treatment

Results posted on

2018-05-14

Participant milestones
Measure	Placebo run-in Followed by Cat-PAD All participants; received two intradermal doses of placebo (saline) followed by eight intradermal administrations of Cat-PAD.
Overall Study STARTED	16
Overall Study Placebo run-in	16
Overall Study Active Treatment	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	Placebo run-in Followed by Cat-PAD All participants; received two intradermal doses of placebo (saline) followed by eight intradermal administrations of Cat-PAD.
Overall Study Adverse Event	1
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	1

Paediatric Safety Study in Cat-PAD

Baseline characteristics by cohort
Measure	Study Participants n=16 Participants Overall study participants
Age, Categorical <=18 years	16 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Poland	16 Participants n=5 Participants

Timeframe: up to 36 weeks after start of treatment

Population: All subjects enrolled

To evaluate the safety and tolerability of Cat-PAD in paediatric subjects aged 5 to \<12 years.

Outcome measures
Measure	Study Participants n=16 Participants Overall study participants
Number of Subjects With AEs Adverse Events Cat-PAD	12 participants
Number of Subjects With AEs Adverse Events Placebo	5 participants

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events
Measure	Placebo run-in n=16 participants at risk Placebo run-in	Cat-PAD n=16 participants at risk Active treatment (Cat-PAD)
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/16 • Overall study (up to 36 weeks after the start of treatment)	6.2% 1/16 • Number of events 1 • Overall study (up to 36 weeks after the start of treatment)
Infections and infestations pneumonia	0.00% 0/16 • Overall study (up to 36 weeks after the start of treatment)	6.2% 1/16 • Number of events 1 • Overall study (up to 36 weeks after the start of treatment)

Circassia Ltd

Phone: +44 1864 405560

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER