NCT01921257

Brief Summary

Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 17, 2018

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

2.3 years

First QC Date

July 17, 2013

Results QC Date

March 19, 2018

Last Update Submit

May 11, 2018

Conditions

Rhinoconjunctivitis

Keywords

Cat AllergyRhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With AEs

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

    up to 36 weeks after start of treatment

Study Arms (1)

Treatment

EXPERIMENTAL

Cat-PAD and Placebo

Drug: Cat-PADDrug: Placebo

Interventions

Cat-PADDRUG
Treatment
PlaceboDRUG
Treatment

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Tarnów, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Results Point of Contact

Title
VP Clinical Operations
Organization
Circassia Ltd
+44 1864 405560

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2013

First Posted

August 13, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 14, 2018

Results First Posted

April 17, 2018

Record last verified: 2018-05

Locations

PL(3)