NCT00439621

Brief Summary

The purpose of the study is to evaluate safety and efficacy of three doses and two dosing regimens of RP01 as an anti-IgE immunotherapy in allergic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

February 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 18, 2008

Status Verified

August 1, 2008

Enrollment Period

1.1 years

First QC Date

February 22, 2007

Last Update Submit

August 13, 2008

Conditions

Allergy

Keywords

immunotherapyallergy

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    0-12 months

Secondary Outcomes (1)

  • Immune kinetic parameters

    0-12 months

Study Arms (4)

1

EXPERIMENTAL
Biological: RP 01

2

EXPERIMENTAL
Biological: RP 01

3

EXPERIMENTAL
Biological: RP 01

4

PLACEBO COMPARATOR
Biological: RP 01

Interventions

RP 01BIOLOGICAL

Active immunotherapy

1234

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Allergy to at least one aero allergen
  • Increased serum IgE level

You may not qualify if:

  • Diagnosis of asthma
  • Recent use of systemic corticosteroids or immunosuppressive treatment
  • Allergy vaccination therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

P3 Research

Tauranga, New Zealand

Location

P3 Research

Wellington, New Zealand

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Vidar Wendel-Hansen, MD, PhD

    Resistentia Pharmaceuticals AB

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 22, 2007

First Posted

February 23, 2007

Study Start

February 1, 2007

Primary Completion

March 1, 2008

Study Completion

August 1, 2008

Last Updated

August 18, 2008

Record last verified: 2008-08

Locations

NZ(2)