AllergyPhase 3RhapsodyNCT04881461
A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis
A Phase 3 study testing 5-grass mix SLIT-drops in people with Allergy, run by ALK-Abelló A/S at 48 sites in 6 countries.
Trial summary
This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, PGPS) The study will collect health-related quality of life data in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergy
- What is being tested?
- 5-grass mix SLIT-drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 445 participants
- Where
- 48 sitesin 6 countries
- Study dates
- 10 May 2021to 26 Sep 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 years on the day informed consent is obtained
- A clinical history of grass pollen-induced allergic rhinoconjunctivitis for two years or more with or without asthma
- A clinical history of severe allergic rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep) induced by grass pollen, which remain troublesome despite symptomatic treatment with antihistamines, nasal steroids or eye drops during the previous grass pollen season
- Positive specific immunoglobulin E (IgE) (defined as ≥class 2, ≥0.70 kU/l) against grass: Phleum pratense
- Positive skin prick test to Phleum pratense at screening
Who cannot join
- Has a clinically relevant history of symptomatic seasonal and/or perennial allergic rhinoconjunctivitis and/or asthma caused by an allergen other than grass pollen, to which the subject is exposed, which could potentially overlap with the efficacy assessment periods
- Within the last 3 months before the randomisation visit, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
- SLIT treatment with any grass pollen AIT for more than 1 month within the last 5 years. In addition, any SLIT treatment with grass pollen AIT within the previous 12 months
- SCIT treatment with any grass AIT reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with grass AIT within the previous 12 months
- Ongoing treatment with any allergy immunotherapy product
- Uncontrolled or severe asthma requiring daily use of more than 800 mcg budesonide or equivalent at screening
Trial locations and contacts
48 sites in 6 countries.
48 sites in 6 countries
Poland15 sites
Indywidualna Specjalistyczna Praktyka Lekarska Anna Latos
Kielce, 25-017
Grażyna Pulka Centrum Medyczne ALL-MED
Krakow, Lesser Poland Voivodeship, 30-033
Centrum Usług Medycznych Dyga-Med
Krakow, 31-033
Grażyna Jasieniak-Pinis ATOPIA NZOZ Poradnie Specjalistyczne
Krakow, 31-159
Barbara Rewerska Diamond Clinic
Krakow, 33-559
Specjalistyczna Przychodnia Alergologiczna Centrum Alergologii
Lublin, 20-552
Snzoz Alergologia Plus Ośrodek Diagnostyki i Terapii Uczuleń
Poznan, Greater Poland Voivodeship, 60-693
Centrum Alergologii T.Hofman Sp. Z o.o.
Poznan, 60-214
Snzoz Imedica
Poznan, 60-537
Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz
Rzeszów, 35051
Alergo-Med Specjalistycza Przychodnia Lekarska Sp. zo.o.
Tarnów, Maopolskie, 33-100
Gabinet Lekarski Bozena Kubicka-Kozik
Tomaszów Mazowiecki, 97-200
ALL-MED. Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy. Marek Jutel.
Wroclaw, 53-201
NZOZ Centrum Usług Medycznych Proximum Sp. z o.o.
Wroclaw, 53-428
Lekarze Specjaliści Malolepszy i Partnerzy
Wroclaw, 54-239
Czechia9 sites
Fakultni Nemocnice u Sv. Anny - FNUSA
Brno, 65691
Ambulance alergologie a klinicke imunologie - Ceske Budejovice
České Budějovice, 37001
Alergopraktik s.r.o.
Jablonec nad Nisou, 46601
Allergology Jihlava
Jihlava, 58601
Alergologicka Ambulance - Liberec
Liberec, 46001
Alergomyšl s.r.o
Litomyšl, 570 01
Acredula Benedicta s.r.o.
Pardubice, 53002
KASMED s.r.o.
Tábor, 39002
MUJ ALERGOLOG s.r.o.
Trutnov, 54101
France9 sites
Cabinet medical
Fenouillet, 31150
Cabinet medical
Hyères, 83400
Cabinet medical
Joué-lès-Tours, 37300
Hopital Privé de la Loire
Loiré, Saint-Étienne, 42100
Cabinet medical
Paris, 75012
Cabinet médical
Rezé, 44400
Cabinet medical
Saint-Quentin, 02100
Nouvel Hopital Civil
Strasbourg, 67091
CHU Hôpital Larrey
Toulouse, 31059
Lithuania8 sites
JSC Ausros Medicinos Centras
Kaunas, 49387
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, 50161
JSC Inlita, Klaipedos CTC
Klaipėda, 92231
JSC Seimos gydytojas
Vilnius, 01118
JSC Center of Innovative Allergology
Vilnius, 06256
JSC INLITA, Santaros CTC
Vilnius, 08406
Allergy Clinic JSC Perspektyvos
Vilnius, 08564
JSC Center for Diagnosis and Treatment of Allergic Diseases
Vilnius, LT-08109
Latvia6 sites
M & M Centrs LTD
Adazi, LV-2164
Balvu and Gulbenes hospital union
Balvi, LV-4501
Daugavpils Regional hospital, Outpatient clinic
Daugavpils, LV-5401
Vevere Viktorija - Doctor's Practice in Pneumology and Allergology
Rēzekne, LV-4601
Ozola Inese - Family doctor's practice
Riga, LV-1003
The Centre of Investigation and Treatment of Allergic Diseases
Riga, LV-1003
About this study
Official title: A Randomised, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of 5-grass Mix SLIT-drops in Adults With Grass Pollen-induced Rhinoconjunctivitis
This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, PGPS)
The study will collect health-related quality of life data in the groups treated with 5-grass mix SLIT-drops or with placebo during the first and second PGPS.
The trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.
Read the detailed description
This trial is a 2 year, parallel-group, double-blind, placebo-controlled phase III trial to evaluate efficacy and safety of the 5-grass mix SLIT-drops in adults with grass pollen-induced rhinoconjunctivitis with or without asthma. Approximately 440 adults will be enrolled in the trial and will receive the 5-grass mix SLIT-drops or placebo. The trial is conducted in several European countries.
- Conditions
- Allergy
- Being tested
- 5-grass mix SLIT-drops, Placebo
- Keywords
- Allergic rhinoconjunctivitis, Adults, Grass
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-grass mix SLIT-dropsDrug
Also called SLIToneULTRA
Sublingual allergy immunotherapy drops, for daily administration
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Glycerol, carbonate, sodium chloride One single-dose container (0.5 ml) once daily Receives: Drug: Placebo |
| 5-grass mix SLIT-drops | Experimental | Grass mix sublingual allergy immunotherapy drops One single-dose container (0.5 ml) once daily. 50 SRU/day for five consecutive days followed by 150 SRU/day for five additional consecutive days. Maintenance: 300 SRU/day from day 11. Receives: Drug: 5-grass mix SLIT-drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS)
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.
Measured: During the 2nd PGPS (14 days)
Secondary outcomes (15)
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Peak Grass Pollen Season (PGPS)
The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd PGPS.
Measured: During the 2nd PGPS (14 days)
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Peak Grass Pollen Season (PGPS)
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.
Measured: During the 1st PGPS (14 days)
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Peak Grass Pollen Season (PGPS)
The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st PGPS.
Measured: During the 1st PGPS (14 days)
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Entire Grass Pollen Season (EGPS)
The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st EGPS.
Measured: During the 1st EGPS (observed mean duration of approximately 8 weeks)
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Entire Grass Pollen Season (EGPS)
The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd EGPS.
Measured: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Entire Grass Pollen Season (EGPS)
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.
Measured: During the 1st EGPS (observed mean duration of approximately 8 weeks)
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Entire Grass Pollen Season (EGPS)
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.
Measured: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Peak Grass Pollen Season (PGPS)
The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.
Measured: During the 1st PGPS (14 days)
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Peak Grass Pollen Season (PGPS)
The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.
Measured: During the 2nd PGPS (14 days)
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Entire Grass Pollen Season (EGPS)
The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.
Measured: During the 1st EGPS (observed mean duration of approximately 8 weeks)
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Entire Grass Pollen Season (EGPS)
The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.
Measured: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Peak Grass Pollen Season (PGPS)
The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.
Measured: During the 1st PGPS (14 days)
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Peak Grass Pollen Season (PGPS)
The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale of 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.
Measured: During the 2nd PGPS (14 days)
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Entire Grass Pollen Season (EGPS)
The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication(on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.
Measured: During the 1st EGPS (observed mean duration of approximately 8 weeks)
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Entire Grass Pollen Season (EGPS)
The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.
Measured: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start10 May 2021
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Laurent Guilleminault, MD, Principal investigator, CHU Hôpital Larrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881461
- Sponsor's protocol ID
- SU-G-01
- Other IDs
- 2020-000455-12
- Acronym
- Rhapsody
- Status last verified
- Dec 2024
- First submitted
- 18 Mar 2021
- Last updated
- 16 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of 5-grass Mix SLIT-drops in Adults With Grass Pollen-induced Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT04881461
- Acronym / sponsor ID
- Rhapsody / SU-G-01
- Conditions
- Allergy
- Keywords
- Allergic rhinoconjunctivitis, Adults, Grass
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 10 May 2021 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Posted 16 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, PGPS)
The study will collect health-related quality of life data in the groups treated with 5-grass mix SLIT-drops or with placebo during the first and second PGPS.
The trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.
Detailed description
This trial is a 2 year, parallel-group, double-blind, placebo-controlled phase III trial to evaluate efficacy and safety of the 5-grass mix SLIT-drops in adults with grass pollen-induced rhinoconjunctivitis with or without asthma. Approximately 440 adults will be enrolled in the trial and will receive the 5-grass mix SLIT-drops or placebo. The trial is conducted in several European countries.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboGlycerol, carbonate, sodium chloride One single-dose container (0.5 ml) once daily |
| 5-grass mix SLIT-drops | Experimental | Drug: 5-grass mix SLIT-dropsGrass mix sublingual allergy immunotherapy drops One single-dose container (0.5 ml) once daily. 50 SRU/day for five consecutive days followed by 150 SRU/day for five additional consecutive days. Maintenance: 300 SRU/day from day 11. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged ≥18 years on the day informed consent is obtained
- A clinical history of grass pollen-induced allergic rhinoconjunctivitis for two years or more with or without asthma
- A clinical history of severe allergic rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep) induced by grass pollen, which remain troublesome despite symptomatic treatment with antihistamines, nasal steroids or eye drops during the previous grass pollen season
- Positive specific immunoglobulin E (IgE) (defined as ≥class 2, ≥0.70 kU/l) against grass: Phleum pratense
- Positive skin prick test to Phleum pratense at screening
Key exclusion criteria (6 listed)
- Has a clinically relevant history of symptomatic seasonal and/or perennial allergic rhinoconjunctivitis and/or asthma caused by an allergen other than grass pollen, to which the subject is exposed, which could potentially overlap with the efficacy assessment periods
- Within the last 3 months before the randomisation visit, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
- SLIT treatment with any grass pollen AIT for more than 1 month within the last 5 years. In addition, any SLIT treatment with grass pollen AIT within the previous 12 months
- SCIT treatment with any grass AIT reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with grass AIT within the previous 12 months
- Ongoing treatment with any allergy immunotherapy product
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 |
|---|---|---|
| 5-grass mix SLIT-dropsAlso: SLIToneULTRASublingual allergy immunotherapy drops, for daily administration | Drug | 5-grass mix SLIT-drops |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS)
Time frame: During the 2nd PGPS (14 days)
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.
15 secondary outcomes
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Peak Grass Pollen Season (PGPS)
Time frame: During the 2nd PGPS (14 days)
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Peak Grass Pollen Season (PGPS)
Time frame: During the 1st PGPS (14 days)
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Peak Grass Pollen Season (PGPS)
Time frame: During the 1st PGPS (14 days)
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Entire Grass Pollen Season (EGPS)
Time frame: During the 1st EGPS (observed mean duration of approximately 8 weeks)
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Entire Grass Pollen Season (EGPS)
Time frame: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Entire Grass Pollen Season (EGPS)
Time frame: During the 1st EGPS (observed mean duration of approximately 8 weeks)
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Entire Grass Pollen Season (EGPS)
Time frame: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Peak Grass Pollen Season (PGPS)
Time frame: During the 1st PGPS (14 days)
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Peak Grass Pollen Season (PGPS)
Time frame: During the 2nd PGPS (14 days)
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Entire Grass Pollen Season (EGPS)
Time frame: During the 1st EGPS (observed mean duration of approximately 8 weeks)
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Entire Grass Pollen Season (EGPS)
Time frame: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Peak Grass Pollen Season (PGPS)
Time frame: During the 1st PGPS (14 days)
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Peak Grass Pollen Season (PGPS)
Time frame: During the 2nd PGPS (14 days)
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Entire Grass Pollen Season (EGPS)
Time frame: During the 1st EGPS (observed mean duration of approximately 8 weeks)
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Entire Grass Pollen Season (EGPS)
Time frame: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Laurent Guilleminault, MD principal investigator
CHU Hôpital Larrey
48 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5-grass mix SLIT-drops in people with Allergy, run by ALK-Abelló A/S at 48 sites in 6 countries.
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 5 inclusion and 6 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Poland, Czechia, France, Lithuania, Latvia and 1 more country. 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?
Yes. Results are posted in the registry (first posted 16 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS) (time frame: During the 2nd PGPS (14 days)). 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 16 Dec 2024.