RhinoconjunctivitisPhase 3NCT01353755
2nd Pivotal Study rPhleum - Adults and Adolescents With Rhinoconjunctivitis +/-Controlled Asthma
A Phase 3 study testing Grass pollen specific immunotherapy and Placabo in people with Rhinoconjunctivitis and Allergic Asthma, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
Trial summary
To evaluate efficacy and tolerability of specific subcutaneous immunotherapy with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) in subjects with rhinoconjunctivitis caused by grass pollen with/without controlled asthma. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Rhinoconjunctivitis, Allergic Asthma
- What is being tested?
- Grass pollen specific immunotherapy and Placabo
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Sep 2014
- Phase
- Phase 3
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has the subject given informed consent according to local requirements before any trial-related activities?
- Is the subject a legally competent male or female outpatient?
- Is the subject aged 12 - 65 year?
- Does the subject suffer from IgE-mediated seasonal allergic rhinoconjunctivitis with or without asthma (controlled, acc. to GINA 2006) caused by grass pollen documented by
- skin prick test wheal for grass pollen ≥ 5mm in diameter and
- histamine (1,0% histamindihydrochloride ) wheal ≥ 3mm and
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- NaCl control reaction < 3mm and
- EAST result (inhouse Allergopharma) ≥ 1.5kU/L to grass pollens and
- proven clinical relevance of grass pollen allergy by positive conjunctival provocation testing with grass pollen allergens and
- main discomfort in the respective months.
- Does the subject with bronchial asthma at entry have a confirmed diagnosis of asthma and does his asthma has been classified as "controlled" according to GINA guidelines (version 2006) with PEF or FEV1at least 80% of predicted normal?
- Has the subject been treated with anti-allergic medications for at least 2 years prior to enrolment? (Subjects with perennial and continuously treated asthma have to be excluded, see "exclusion criteria" below.)
- For female patients: Does the subject use effective contraception and does she have a negative pregnancy test result? (Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectibles, combined or oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. No pharmacological interactions are known for hormonal contraceptives and specific immunotherapeutic preparations.)
- Does the subject suffer from rhinoconjunctivitis symptoms documented in the subjects diary during the baseline season?
- Does the subject have demonstrated a symptom-score of at least 4 per day during the week following the peak pollen count in the baseline season?
Who cannot join
- Is the subject unable to understand and comply with the requirements of the trial, as judged by the investigator?
- Is the subject currently participating in any other trial or has the subject participated in any other trial within 30 days before inclusion in this trial?
- Is/was the subject involved in the planning and conduct of the trial?
- Is the subject an employee of Allergopharma Joachim Ganzer KG or of one of the trial sites?
- Is the subject in any relationship of dependence with the sponsor and/or with the investigator?
- Has the subject been previously enrolled or randomised to treatment in the present trial?
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- Is the subject mentally disabled?
- Is the subject institutionalised due to an official or judicial order?
- Does the subject have a positive pregnancy test before the baseline phase?
- Does the subject use an unacceptable and unreliable contraceptive method during the trial, as judged by the investigator?
- Is the subject pregnant or within the lactation period?
- Is the subject seeking to become pregnant?
- Has the subject undergone previous specific immunotherapy with grass pollen allergens in any formulation?
- Is the subject currently undergoing any sort of immunotherapy?
- Has the subject ever undergone specific immunotherapy with unknown allergen or an unsuccessful immunotherapy?
- For allergens which interfere with the grass pollen season for all participating countries
- Does the subject suffer from any clinically relevant perennial allergies (e.g. cat, mite) and clinical relevance can not be excluded?
- Does the subject show a total IgE of > 2000kU/l?
- Does the subject suffer from clinically relevant rhino-conjunctival or respiratory symptoms related to other reasons?
- Has the subject a PEF or FEV1 < 80% of predicted normal (ECSC)?
- Has the subject uncontrolled or partly controlled asthma according to GINA guidelines (version 2006)?
- Does the subject suffer from perennial and continuously treated asthma?
- Does the subject suffer from rhinoconjunctival atopy symptoms for 20 years or longer?
- Does the subject suffer from severe acute or chronic diseases (e.g. Diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys)?
- Does the subject suffer from autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies?
- Does the subject suffer from severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)?
- Does the subject suffer from recurrent seizures?
- Does the subject suffer from irreversible secondary alterations of the reactive organ (e.g., emphysema, bronchiectasis etc.)?
- Has the subject any physiological and laboratory variables within/outside normal limits and as reported to be greater than Grade 1 changes according to the FDA Guidance for Industry?
- Is the subject treated with beta-blockers (locally and systemically)?
- Has the subject any contraindication for use of adrenalin (e.g., acute or chronic symptomatic coronary heart disease, severe hypertension)?
- Has the subject completed or has an ongoing treatment with anti-IgEantibody?
- Has the subject completed or has an ongoing long-term treatment with tranquilizer or other psychoactive drugs?
- Is the subject treated for allergy or asthma according to severity of symptoms?
- Is the subject using any prophylactic and any treatment with antiallergic medication in fixed (constant) dosage during the treatment phase of the trial?
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Double Blind Placebo Controlled Pivotal Study to Evaluate Efficacy and Safety of rPhleum in Adult and Adolescent Patients Suffering From Rhinoconjunctivitis +/- Controlled Asthma
To evaluate efficacy and tolerability of specific subcutaneous immunotherapy with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) in subjects with rhinoconjunctivitis caused by grass pollen with/without controlled asthma.
- Conditions
- Rhinoconjunctivitis, Allergic Asthma
- Being tested
- Grass pollen specific immunotherapy, Placabo
- Keywords
- specific immunotherapy, SIT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grass pollen specific immunotherapyDrug
- Strength 1 (0.78μg/mL)
- Strength 2 (6.25μg/mL)
- Strength 3 (50μg/mL)
- Strength 4 (200μg/mL)
The subcutaneous injections will be administered at intervals of 7 (+ 7 days)during up-titration. For maintenance the injection intervals are prolonged to 4 weeks (+2). The double blind treatment period is 2 years, followed by 1 year open-label treatment for patients previously treated with verum and 3 years open-label treatment for patients previously recieved placebo.
PlacaboDrug
Placebo will be administered in the same way as the test product. Placebo will be identical in terms of appearance to the IMP.
| Study group | Role | What they receive |
|---|---|---|
| recombinant Phleum (rPhleum) allergen cocktail | Experimental | The recombinant Phleum (rPhleum) allergen cocktail is prepared by mixing equivalent volumes of each single allergen adsorbate. The recombinant Phleum (rPhleum) allergen cocktail contains Phleum pratense (Phl p) allergens: Type 1, 2, 5 and 6 at equimolar quatities. The total protein concentration in the highest strength is 200μg protein per 1mL aluminium hydroxide suspension. Receives: Drug: Grass pollen specific immunotherapy |
| Placebo | Placebo comparator | Placebo will be administered in the same way as the test product. Placebo will be identical in terms of appearance to the IMP. Receives: Drug: Placabo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhinoconjunctivitis Symptom-Medication-Score
Change of the AUC of the RC-SMS from the baseline season to the season after 2 years of treatment
Measured: 2 years
Secondary outcomes (1)
adverse events
Safety of treatment during the entire trial period will be assessed by clinical laboratory, vital signs and adverse events displayed by MedDRA SOC and Preferred Term.
Measured: entire trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startOct 2009
- Primary completionAug 2012
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinoconjunctivitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Hunzelmann, Prof. Dr., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353755
- Sponsor's protocol ID
- AL0906rP
- Other IDs
- 2009-011504-36, 2009
- Status last verified
- Nov 2014
- First submitted
- 13 May 2011
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Double Blind Placebo Controlled Pivotal Study to Evaluate Efficacy and Safety of rPhleum in Adult and Adolescent Patients Suffering From Rhinoconjunctivitis +/- Controlled Asthma
- ClinicalTrials.gov ID
- NCT01353755
- Acronym / sponsor ID
- AL0906rP
- Conditions
- Rhinoconjunctivitis, Allergic Asthma
- Keywords
- specific immunotherapy, SIT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 16 May 2011 (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.
To evaluate efficacy and tolerability of specific subcutaneous immunotherapy with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) in subjects with rhinoconjunctivitis caused by grass pollen with/without controlled asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| recombinant Phleum (rPhleum) allergen cocktail | Experimental | Drug: Grass pollen specific immunotherapyThe recombinant Phleum (rPhleum) allergen cocktail is prepared by mixing equivalent volumes of each single allergen adsorbate. The recombinant Phleum (rPhleum) allergen cocktail contains Phleum pratense (Phl p) allergens: Type 1, 2, 5 and 6 at equimolar quatities. The total protein concentration in the highest strength is 200μg protein per 1mL aluminium hydroxide suspension. |
| Placebo | Placebo comparator | Drug: PlacaboPlacebo will be administered in the same way as the test product. Placebo will be identical in terms of appearance to the IMP. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Has the subject given informed consent according to local requirements before any trial-related activities?
- Is the subject a legally competent male or female outpatient?
- Is the subject aged 12 - 65 year?
- Does the subject suffer from IgE-mediated seasonal allergic rhinoconjunctivitis with or without asthma (controlled, acc. to GINA 2006) caused by grass pollen documented by
- Has the subject been treated with anti-allergic medications for at least 2 years prior to enrolment? (Subjects with perennial and continuously treated asthma have to be excluded, see "exclusion criteria" below.)
Key exclusion criteria (35 listed)
- Is the subject unable to understand and comply with the requirements of the trial, as judged by the investigator?
- Is the subject currently participating in any other trial or has the subject participated in any other trial within 30 days before inclusion in this trial?
- Is/was the subject involved in the planning and conduct of the trial?
- Is the subject an employee of Allergopharma Joachim Ganzer KG or of one of the trial sites?
- Is the subject in any relationship of dependence with the sponsor and/or with the investigator?
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 |
|---|---|---|
| Grass pollen specific immunotherapy* Strength 1 (0.78μg/mL) * Strength 2 (6.25μg/mL) * Strength 3 (50μg/mL) * Strength 4 (200μg/mL) The subcutaneous injections will be administered at intervals of 7 (+ 7 days)during up-titration. For maintenance the injection intervals are prolonged to 4 weeks (+2). The double blind treatment period is 2 years, followed by 1 year open-label treatment for patients previously treated with verum and 3 years open-label treatment for patients previously recieved placebo. | Drug | recombinant Phleum (rPhleum) allergen cocktail |
| PlacaboPlacebo will be administered in the same way as the test product. Placebo will be identical in terms of appearance to the IMP. | Drug | Placebo |
Primary outcome
Rhinoconjunctivitis Symptom-Medication-Score
Time frame: 2 years
Change of the AUC of the RC-SMS from the baseline season to the season after 2 years of treatment
1 secondary outcome
adverse events
Time frame: entire trial
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 13 Nov 2014.
- Click here for information about this trial in the European Clinical Trials RegisterLink provided by the sponsor.
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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.
Nicolas Hunzelmann, Prof. Dr. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Grass pollen specific immunotherapy and Placabo in people with Rhinoconjunctivitis and Allergic Asthma, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
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 15 inclusion and 35 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 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Rhinoconjunctivitis Symptom-Medication-Score (time frame: 2 years). 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 13 Nov 2014.