RhinoconjunctivitisPhase 3AMETHYSTNCT00671268
Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma
A Phase 3 study testing AL0704rP in people with Rhinoconjunctivitis, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
Trial summary
Efficacy and Safety from a high-dosed subcutaneous recombinant preparation Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rhinoconjunctivitis
- What is being tested?
- AL0704rP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2008to Mar 2013
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Allergic rhinoconjunctivitis attributable to grass pollen
- Positive SPT
- Positive EAST
- Positive provocation test
Who cannot join
- serious disease
- other perennial allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre, Multinational Randomised DBPC Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma
Efficacy and Safety from a high-dosed subcutaneous recombinant preparation
- Conditions
- Rhinoconjunctivitis
- Being tested
- AL0704rP, Placebo
- Keywords
- Grass pollen allergy, specific immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL0704rPBiological
Also called "na"
strict subcutaneous
PlaceboBiological
Also called "na"
strict subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | strict subcutaneous Receives: Biological: AL0704rP |
| 2 | Placebo comparator | strict subcutaneous Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Symptom and Medication score
Measured: during the baseline and the following two pollen seasons
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2012
- Study completionMar 2013
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margitta Worm, Professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671268
- Sponsor's protocol ID
- AL0704rP
- Other IDs
- 2007-003208-37
- Acronym
- AMETHYST
- Status last verified
- Nov 2013
- First submitted
- 23 Apr 2008
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
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
- Multicentre, Multinational Randomised DBPC Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma
- ClinicalTrials.gov ID
- NCT00671268
- Acronym / sponsor ID
- AMETHYST / AL0704rP
- Conditions
- Rhinoconjunctivitis
- Keywords
- Grass pollen allergy, specific immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 May 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.
Efficacy and Safety from a high-dosed subcutaneous recombinant preparation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: AL0704rPstrict subcutaneous |
| 2 | Placebo comparator | Biological: Placebostrict subcutaneous |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Allergic rhinoconjunctivitis attributable to grass pollen
- Positive SPT
- Positive EAST
- Positive provocation test
Key exclusion criteria (2 listed)
- serious disease
- 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 |
|---|---|---|
| AL0704rPAlso: "na"strict subcutaneous | Biological | 1 |
| PlaceboAlso: "na"strict subcutaneous | Biological | 2 |
Primary outcome
Change of Symptom and Medication score
Time frame: during the baseline and the following two pollen seasons
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.
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Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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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.
Margitta Worm, Professor 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 AL0704rP in people with Rhinoconjunctivitis, 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 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?
Change of Symptom and Medication score (time frame: during the baseline and the following two pollen seasons). 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; AzTrials last refreshed its copy on 8 Nov 2026.