Type I-AllergyPhase 2NCT00666341
Dose-Response-Study With a Recombinant Cocktail of Phleum (rPhleum) Allergens
A Phase 2 study testing rPhleum in people with Type I-Allergy, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
Trial summary
Dose-response trial with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type I-Allergy
- What is being tested?
- rPhleum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to May 2010
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- main symptoms of allergic rhinitis/rhinoconjunctivitis with or without controlled asthma against grass pollen allergens
- positive SPT
- positive EAST
- positive specific provocation test
Who cannot join
- serious chronic diseases
- other perennial allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Placebo-controlled Dose-response Study for Evaluation of Safety and Efficacy of Immunotherapy With a Cocktail of Recombinant Major Allergens of Timothy Grass Pollen (Phleum Pratense) Adsorbed to Aluminium Hydroxide in Patients With IgE-mediated Allergic Rhinitis/Rhinoconjunctivitis With or Without Bronchial Asthma
Dose-response trial with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense)
- Conditions
- Type I-Allergy
- Being tested
- placebo, rPhleum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Also called Comparator
Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.
rPhleumBiological
Also called Specific Immunotherapy
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg)
rPhleumBiological
Also called Specific Immunotherapy
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)
rPhleumBiological
Also called Specific Immunotherapy
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)
rPhleumBiological
Also called Specific Immunotherapy
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4. Receives: Drug: placebo |
| 20 μg rPhleum Immunotherapy | Experimental | Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg) Receives: Biological: rPhleum |
| 40 μg rPhleum Immunotherapy | Experimental | Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg) Receives: Biological: rPhleum |
| 80 μg rPhleum Immunotherapy | Experimental | Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg) Receives: Biological: rPhleum |
| 120 μg rPhleum Immunotherapy | Experimental | Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg) Receives: Biological: rPhleum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic reaction (according to Tryba)
Number of patients with at least one systemic reaction (according to Tryba Grade 1-4) with possible, probable or definite relationship to the study medication determined at the end of the uptitration phase.
Measured: uptitration phase
Secondary outcomes (1)
Late Phase Reactions
Changes of the Late Phase Reactions in specific intracutaneous test with natural allergen before and at the end of the double-blind placebo controlled phase before grass pollen season.
Measured: before and at the end of the double-blind phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startSep 2007
- Primary completionJan 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I-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, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl Hörmann, MD, Study chair, Universitätsklinikum Mannheim GMBH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666341
- Sponsor's protocol ID
- AL0701rP
- Other IDs
- 2007-002808-18
- Status last verified
- Nov 2013
- First submitted
- 21 Apr 2008
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Placebo-controlled Dose-response Study for Evaluation of Safety and Efficacy of Immunotherapy With a Cocktail of Recombinant Major Allergens of Timothy Grass Pollen (Phleum Pratense) Adsorbed to Aluminium Hydroxide in Patients With IgE-mediated Allergic Rhinitis/Rhinoconjunctivitis With or Without Bronchial Asthma
- ClinicalTrials.gov ID
- NCT00666341
- Acronym / sponsor ID
- AL0701rP
- Conditions
- Type I-Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 24 Apr 2008 (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.
Dose-response trial with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboPlacebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4. |
| 20 μg rPhleum Immunotherapy | Experimental | Biological: rPhleumCocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg) |
| 40 μg rPhleum Immunotherapy | Experimental | Biological: rPhleumCocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg) |
| 80 μg rPhleum Immunotherapy | Experimental | Biological: rPhleumCocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg) |
| 120 μg rPhleum Immunotherapy | Experimental | Biological: rPhleumCocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- main symptoms of allergic rhinitis/rhinoconjunctivitis with or without controlled asthma against grass pollen allergens
- positive SPT
- positive EAST
- positive specific provocation test
Key exclusion criteria (2 listed)
- serious chronic diseases
- other perennial allergies
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 |
|---|---|---|
| placeboAlso: ComparatorPlacebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4. | Drug | Placebo |
| rPhleumAlso: Specific ImmunotherapyCocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg) | Biological | 20 μg rPhleum Immunotherapy |
| rPhleumAlso: Specific ImmunotherapyCocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg) | Biological | 40 μg rPhleum Immunotherapy |
| rPhleumAlso: Specific ImmunotherapyCocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg) | Biological | 80 μg rPhleum Immunotherapy |
| rPhleumAlso: Specific ImmunotherapyCocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg) | Biological | 120 μg rPhleum Immunotherapy |
Primary outcome
Systemic reaction (according to Tryba)
Time frame: uptitration phase
Number of patients with at least one systemic reaction (according to Tryba Grade 1-4) with possible, probable or definite relationship to the study medication determined at the end of the uptitration phase.
1 secondary outcome
Late Phase Reactions
Time frame: before and at the end of the double-blind phase
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 8 Nov 2013.
- Leader in specific allergy research and therapyLink provided by the sponsor.
- Click here for information about this trial in the European Clinical Trials RegisterLink provided by the sponsor.
Related trials for Type I-Allergy
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
RecruitingObservational study
Washed Microbiota Transplantation for Type 1 Diabetes Mellitus
Type 1 Diabetes
Active, not recruiting
The COCCOS Study: a Transition Program for Young Persons With Chronic Conditions
Type 1 Diabetes Mellitus, Obesity
RecruitingObservational study
Impaired Type I IFN Immunity Due to Autoantibodies or a Genetic Defect: a Prospective National Cohort
Immunology, Allergy
RecruitingPhase 2
METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)
Type 1 Diabetes (T1D), Metabolic Diseases
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.
Karl Hörmann, MD study chair
Universitätsklinikum Mannheim GMBH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rPhleum in people with Type I-Allergy, 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 4 inclusion and 2 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 8 Nov 2013. 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 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?
Systemic reaction (according to Tryba) (time frame: uptitration phase). 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 8 Nov 2013.