AllergyPhase 2NCT00439621
Safety Study of Anti-IgE Immunotherapy in Allergic Patients
A Phase 2 study testing RP 01 in people with Allergy, run by Resistentia Pharmaceuticals AB at 2 sites in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Allergy
- What is being tested?
- RP 01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesNew Zealand
- Study dates
- Feb 2007to Aug 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Allergy to at least one aero allergen
- Increased serum IgE level
Who cannot join
- Diagnosis of asthma
- Recent use of systemic corticosteroids or immunosuppressive treatment
- Allergy vaccination therapy
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Safety and Tolerability Study of Repeated Doses of Anti-IgE Immunotherapy in Allergic Patients
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.
Read the detailed description
Immunotherapy is based on the principle of eliciting an immune reaction in order to block the negative effect of a specific disease-causing protein. The potential to treat diseases by means of immunotherapy instead of using conventional drugs represents an attractive opportunity in a number of chronic disease areas, including asthma and allergy. Resistentia's model to treat allergic diseases, and ultimately asthma, is to use the immune system to produce antibodies against the IgE molecules themselves. The resulting anti-IgE antibodies intercept and form complexes with the IgE molecules before they can bind to the mast cells and basophils and are thus able to block any allergen-triggered inflammatory reaction. The approach works in all types of IgE-mediated allergies independently of allergen, and also in patients sensitive to multiple allergens.
Comparisons: Three doses and two dosing regimes of RP01 will be compared as regards safety and effect.
- Conditions
- Allergy
- Being tested
- RP 01
- Keywords
- immunotherapy, allergy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP 01Biological
Active immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: RP 01 |
| 2 | Experimental | Not described Receives: Biological: RP 01 |
| 3 | Experimental | Not described Receives: Biological: RP 01 |
| 4 | Placebo comparator | Not described Receives: Biological: RP 01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: 0-12 months
Secondary outcomes (1)
Immune kinetic parameters
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionMar 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resistentia Pharmaceuticals AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Vidar Wendel-Hansen, MD, PhD, Study director, Resistentia Pharmaceuticals AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439621
- Sponsor's protocol ID
- 2006-24
- Status last verified
- Aug 2008
- First submitted
- 22 Feb 2007
- Last updated
- 18 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Safety and Tolerability Study of Repeated Doses of Anti-IgE Immunotherapy in Allergic Patients
- ClinicalTrials.gov ID
- NCT00439621
- Acronym / sponsor ID
- 2006-24
- Conditions
- Allergy
- Keywords
- immunotherapy, allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Resistentia Pharmaceuticals ABIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 23 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Immunotherapy is based on the principle of eliciting an immune reaction in order to block the negative effect of a specific disease-causing protein. The potential to treat diseases by means of immunotherapy instead of using conventional drugs represents an attractive opportunity in a number of chronic disease areas, including asthma and allergy. Resistentia's model to treat allergic diseases, and ultimately asthma, is to use the immune system to produce antibodies against the IgE molecules themselves. The resulting anti-IgE antibodies intercept and form complexes with the IgE molecules before they can bind to the mast cells and basophils and are thus able to block any allergen-triggered inflammatory reaction. The approach works in all types of IgE-mediated allergies independently of allergen, and also in patients sensitive to multiple allergens.
Comparisons: Three doses and two dosing regimes of RP01 will be compared as regards safety and effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: RP 01 |
| 2 | Experimental | Biological: RP 01 |
| 3 | Experimental | Biological: RP 01 |
| 4 | Placebo comparator | Biological: RP 01 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Allergy to at least one aero allergen
- Increased serum IgE level
Key exclusion criteria (3 listed)
- Diagnosis of asthma
- Recent use of systemic corticosteroids or immunosuppressive treatment
- Allergy vaccination therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RP 01Active immunotherapy | Biological | 1, 2, 3, 4 |
Primary outcome
Adverse Events
Time frame: 0-12 months
1 secondary outcome
Immune kinetic parameters
Time frame: 0-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vidar Wendel-Hansen, MD, PhD study director
Resistentia Pharmaceuticals AB
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RP 01 in people with Allergy, run by Resistentia Pharmaceuticals AB at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 0-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2008.