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A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis (Rhapsody)

Primary Purpose

Allergy

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
5-grass mix SLIT-drops
Placebo
Sponsored by
ALK-Abelló A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergy focused on measuring Allergic rhinoconjunctivitis, Adults, Grass

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female aged ≥18 years on the day informed consent is obtained
  2. A clinical history of grass pollen-induced allergic rhinoconjunctivitis for two years or more with or without asthma
  3. 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
  4. Positive specific immunoglobulin E (IgE) (defined as ≥class 2, ≥0.70 kU/l) against grass: Phleum pratense
  5. Positive skin prick test to Phleum pratense at screening

Exclusion Criteria:

  1. 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
  2. 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
  3. 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
  4. 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
  5. Ongoing treatment with any allergy immunotherapy product
  6. Uncontrolled or severe asthma requiring daily use of more than 800 mcg budesonide or equivalent at screening

Sites / Locations

  • Fakultni Nemocnice u Sv. Anny - FNUSA
  • Alergopraktik s.r.o.
  • Allergology Jihlava
  • Alergologicka Ambulance - Liberec
  • Alergomyšl s.r.o
  • Acredula Benedicta s.r.o.
  • MUJ ALERGOLOG s.r.o.
  • KASMED s.r.o.
  • Ambulance alergologie a klinicke imunologie - Ceske Budejovice
  • North Estonia Medical Centre Foundation
  • Hopital Privé de la Loire
  • Cabinet medical
  • Cabinet medical
  • Cabinet medical
  • Cabinet medical
  • Cabinet médical
  • Cabinet medical
  • Nouvel Hopital Civil
  • CHU Hôpital Larrey
  • Balvu and Gulbenes hospital union
  • Daugavpils Regional hospital, Outpatient clinic
  • Ozola Inese - Family doctor's practice
  • The Centre of Investigation and Treatment of Allergic Diseases
  • Vevere Viktorija - Doctor's Practice in Pneumology and Allergology
  • M & M Centrs LTD
  • JSC Ausros Medicinos Centras
  • Hospital of Lithuanian University of Health Sciences Kauno klinikos
  • JSC Inlita, Klaipedos CTC
  • JSC Seimos gydytojas
  • JSC Center of Innovative Allergology
  • JSC INLITA, Santaros CTC
  • Allergy Clinic JSC Perspektyvos
  • JSC Center for Diagnosis and Treatment of Allergic Diseases
  • Grażyna Pulka Centrum Medyczne ALL-MED
  • Alergo-Med Specjalistycza Przychodnia Lekarska Sp. zo.o.
  • Snzoz Alergologia Plus Ośrodek Diagnostyki i Terapii Uczuleń
  • Indywidualna Specjalistyczna Praktyka Lekarska Anna Latos
  • Centrum Usług Medycznych Dyga-Med
  • Grażyna Jasieniak-Pinis ATOPIA NZOZ Poradnie Specjalistyczne
  • Barbara Rewerska Diamond Clinic
  • Specjalistyczna Przychodnia Alergologiczna Centrum Alergologii
  • Centrum Alergologii T.Hofman Sp. Z o.o.
  • Snzoz Imedica
  • Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz
  • Gabinet Lekarski Bozena Kubicka-Kozik
  • ALL-MED. Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy. Marek Jutel.
  • NZOZ Centrum Usług Medycznych Proximum Sp. z o.o.
  • Lekarze Specjaliści Malolepszy i Partnerzy

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

5-grass mix SLIT-drops

Arm Description

Glycerol, carbonate, sodium chloride One single-dose container (0.5 ml) once daily

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.

Outcomes

Primary Outcome Measures

Average daily allergic rhinoconjunctivitis total combined score (TCS) during the 2nd PGPS (Peak Grass Pollen Season)
TCS is the sum of the allergic rhinoconjunctivitis DSS and the allergic rhinoconjunctivitis DMS. DSS, corresponds to a sum of 6 individual symptom scores: runny nose, nasal congestion (blocked nose), sneezing, itchy nose, itchy eyes (gritty feeling, red eyes), and watery eyes. Each symptom will be scored with the following values: no symptoms (0 points), mild symptoms (1 point), moderate symptoms (2 points), or severe symptoms (3 points). Thus, the maximum daily symptom score will be 18. DMS, is based on use according to the need of the symptom relieving medications used. Each dose of medication has a score between 1.5 and 6 (tablet score of 6, nasal spray score of 2 and eye drops score of 1.5 per eye). Maximum daily score is 6, 8 and 6 respectively and the maximum daily score is 20. The higher scores the more symptoms.

Secondary Outcome Measures

Average score of weekly overall rhinitis quality of life questionnaire (RQLQ) during the 2nd PGPS (Peak Grass Pollen Season)
Rhinitis Quality of Life questionnaire. RQLQ questionnaire contains 28 questions that are scored in 7-point scale (0 = not impaired at all; 6 = severely impaired). Questions are divided in 7 domains (activity limitations). The overall RQLQ score a mean of 27 questions. The higher scores the more symptoms.
Average daily allergic rhinoconjunctivitis TCS during the 1st PGPS (Peak Grass Pollen Season)
TCS is the sum of the allergic rhinoconjunctivitis DSS and the allergic rhinoconjunctivitis DMS. DSS, corresponds to a sum of 6 individual symptom scores: runny nose, nasal congestion (blocked nose), sneezing, itchy nose, itchy eyes (gritty feeling, red eyes), and watery eyes. Each symptom will be scored with the following values: no symptoms (0 points), mild symptoms (1 point), moderate symptoms (2 points), or severe symptoms (3 points). Thus, the maximum daily symptom score will be 18. DMS will be based on use according to the need of the rescue medications - scores between 0-20 (The higher values the more rescue medication needed).
Average score of weekly overall RQLQ during the 1st PGPS (Peak Grass Pollen Season)
Rhinitis Quality of Life questionnaire. RQLQ questionnaire contains 28 questions that are scored in 7-point scale (0 = not impaired at all; 6 = severely impaired). Questions are divided in 7 domains (activity limitations). The overall RQLQ score a mean of 27 questions. The higher scores the more symptoms.

Full Information

First Posted
March 18, 2021
Last Updated
August 12, 2022
Sponsor
ALK-Abelló A/S
Collaborators
Syneos Health
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1. Study Identification

Unique Protocol Identification Number
NCT04881461
Brief Title
A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis
Acronym
Rhapsody
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
September 23, 2023 (Anticipated)
Study Completion Date
September 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALK-Abelló A/S
Collaborators
Syneos Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy
Keywords
Allergic rhinoconjunctivitis, Adults, Grass

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
445 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Glycerol, carbonate, sodium chloride One single-dose container (0.5 ml) once daily
Arm Title
5-grass mix SLIT-drops
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
5-grass mix SLIT-drops
Other Intervention Name(s)
SLIToneULTRA
Intervention Description
Sublingual allergy immunotherapy drops, for daily administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Average daily allergic rhinoconjunctivitis total combined score (TCS) during the 2nd PGPS (Peak Grass Pollen Season)
Description
TCS is the sum of the allergic rhinoconjunctivitis DSS and the allergic rhinoconjunctivitis DMS. DSS, corresponds to a sum of 6 individual symptom scores: runny nose, nasal congestion (blocked nose), sneezing, itchy nose, itchy eyes (gritty feeling, red eyes), and watery eyes. Each symptom will be scored with the following values: no symptoms (0 points), mild symptoms (1 point), moderate symptoms (2 points), or severe symptoms (3 points). Thus, the maximum daily symptom score will be 18. DMS, is based on use according to the need of the symptom relieving medications used. Each dose of medication has a score between 1.5 and 6 (tablet score of 6, nasal spray score of 2 and eye drops score of 1.5 per eye). Maximum daily score is 6, 8 and 6 respectively and the maximum daily score is 20. The higher scores the more symptoms.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Average score of weekly overall rhinitis quality of life questionnaire (RQLQ) during the 2nd PGPS (Peak Grass Pollen Season)
Description
Rhinitis Quality of Life questionnaire. RQLQ questionnaire contains 28 questions that are scored in 7-point scale (0 = not impaired at all; 6 = severely impaired). Questions are divided in 7 domains (activity limitations). The overall RQLQ score a mean of 27 questions. The higher scores the more symptoms.
Time Frame
6 months
Title
Average daily allergic rhinoconjunctivitis TCS during the 1st PGPS (Peak Grass Pollen Season)
Description
TCS is the sum of the allergic rhinoconjunctivitis DSS and the allergic rhinoconjunctivitis DMS. DSS, corresponds to a sum of 6 individual symptom scores: runny nose, nasal congestion (blocked nose), sneezing, itchy nose, itchy eyes (gritty feeling, red eyes), and watery eyes. Each symptom will be scored with the following values: no symptoms (0 points), mild symptoms (1 point), moderate symptoms (2 points), or severe symptoms (3 points). Thus, the maximum daily symptom score will be 18. DMS will be based on use according to the need of the rescue medications - scores between 0-20 (The higher values the more rescue medication needed).
Time Frame
6 months
Title
Average score of weekly overall RQLQ during the 1st PGPS (Peak Grass Pollen Season)
Description
Rhinitis Quality of Life questionnaire. RQLQ questionnaire contains 28 questions that are scored in 7-point scale (0 = not impaired at all; 6 = severely impaired). Questions are divided in 7 domains (activity limitations). The overall RQLQ score a mean of 27 questions. The higher scores the more symptoms.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Guilleminault, MD
Organizational Affiliation
CHU Hôpital Larrey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fakultni Nemocnice u Sv. Anny - FNUSA
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
Alergopraktik s.r.o.
City
Jablonec Nad Nisou
ZIP/Postal Code
46601
Country
Czechia
Facility Name
Allergology Jihlava
City
Jihlava
ZIP/Postal Code
58601
Country
Czechia
Facility Name
Alergologicka Ambulance - Liberec
City
Liberec
ZIP/Postal Code
46001
Country
Czechia
Facility Name
Alergomyšl s.r.o
City
Litomyšl
ZIP/Postal Code
570 01
Country
Czechia
Facility Name
Acredula Benedicta s.r.o.
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Facility Name
MUJ ALERGOLOG s.r.o.
City
Trutnov
ZIP/Postal Code
54101
Country
Czechia
Facility Name
KASMED s.r.o.
City
Tábor
ZIP/Postal Code
39002
Country
Czechia
Facility Name
Ambulance alergologie a klinicke imunologie - Ceske Budejovice
City
České Budějovice
ZIP/Postal Code
37001
Country
Czechia
Facility Name
North Estonia Medical Centre Foundation
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Hopital Privé de la Loire
City
Loiré
State/Province
Saint-Étienne
ZIP/Postal Code
42100
Country
France
Facility Name
Cabinet medical
City
Fenouillet
ZIP/Postal Code
31150
Country
France
Facility Name
Cabinet medical
City
Hyeres
ZIP/Postal Code
83400
Country
France
Facility Name
Cabinet medical
City
Joué-lés-Tours
ZIP/Postal Code
37300
Country
France
Facility Name
Cabinet medical
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Cabinet médical
City
Rezé
ZIP/Postal Code
44400
Country
France
Facility Name
Cabinet medical
City
Saint-Quentin
ZIP/Postal Code
02100
Country
France
Facility Name
Nouvel Hopital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHU Hôpital Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Balvu and Gulbenes hospital union
City
Balvi
ZIP/Postal Code
LV-4501
Country
Latvia
Facility Name
Daugavpils Regional hospital, Outpatient clinic
City
Daugavpils
ZIP/Postal Code
LV-5401
Country
Latvia
Facility Name
Ozola Inese - Family doctor's practice
City
Riga
ZIP/Postal Code
LV-1003
Country
Latvia
Facility Name
The Centre of Investigation and Treatment of Allergic Diseases
City
Riga
ZIP/Postal Code
LV-1003
Country
Latvia
Facility Name
Vevere Viktorija - Doctor's Practice in Pneumology and Allergology
City
Rēzekne
ZIP/Postal Code
LV-4601
Country
Latvia
Facility Name
M & M Centrs LTD
City
Ādaži
ZIP/Postal Code
LV-2164
Country
Latvia
Facility Name
JSC Ausros Medicinos Centras
City
Kaunas
ZIP/Postal Code
49387
Country
Lithuania
Facility Name
Hospital of Lithuanian University of Health Sciences Kauno klinikos
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
JSC Inlita, Klaipedos CTC
City
Klaipėda
ZIP/Postal Code
92231
Country
Lithuania
Facility Name
JSC Seimos gydytojas
City
Vilnius
ZIP/Postal Code
01118
Country
Lithuania
Facility Name
JSC Center of Innovative Allergology
City
Vilnius
ZIP/Postal Code
06256
Country
Lithuania
Facility Name
JSC INLITA, Santaros CTC
City
Vilnius
ZIP/Postal Code
08406
Country
Lithuania
Facility Name
Allergy Clinic JSC Perspektyvos
City
Vilnius
ZIP/Postal Code
08564
Country
Lithuania
Facility Name
JSC Center for Diagnosis and Treatment of Allergic Diseases
City
Vilnius
ZIP/Postal Code
LT-08109
Country
Lithuania
Facility Name
Grażyna Pulka Centrum Medyczne ALL-MED
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
30-033
Country
Poland
Facility Name
Alergo-Med Specjalistycza Przychodnia Lekarska Sp. zo.o.
City
Tarnów
State/Province
Maopolskie
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Snzoz Alergologia Plus Ośrodek Diagnostyki i Terapii Uczuleń
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska Anna Latos
City
Kielce
ZIP/Postal Code
25-017
Country
Poland
Facility Name
Centrum Usług Medycznych Dyga-Med
City
Kraków
ZIP/Postal Code
31-033
Country
Poland
Facility Name
Grażyna Jasieniak-Pinis ATOPIA NZOZ Poradnie Specjalistyczne
City
Kraków
ZIP/Postal Code
31-159
Country
Poland
Facility Name
Barbara Rewerska Diamond Clinic
City
Kraków
ZIP/Postal Code
33-559
Country
Poland
Facility Name
Specjalistyczna Przychodnia Alergologiczna Centrum Alergologii
City
Lublin
ZIP/Postal Code
20-552
Country
Poland
Facility Name
Centrum Alergologii T.Hofman Sp. Z o.o.
City
Poznań
ZIP/Postal Code
60-214
Country
Poland
Facility Name
Snzoz Imedica
City
Poznań
ZIP/Postal Code
60-537
Country
Poland
Facility Name
Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz
City
Rzeszów
ZIP/Postal Code
35051
Country
Poland
Facility Name
Gabinet Lekarski Bozena Kubicka-Kozik
City
Tomaszów Mazowiecki
ZIP/Postal Code
97-200
Country
Poland
Facility Name
ALL-MED. Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy. Marek Jutel.
City
Wrocław
ZIP/Postal Code
53-201
Country
Poland
Facility Name
NZOZ Centrum Usług Medycznych Proximum Sp. z o.o.
City
Wrocław
ZIP/Postal Code
53-428
Country
Poland
Facility Name
Lekarze Specjaliści Malolepszy i Partnerzy
City
Wrocław
ZIP/Postal Code
54-239
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis

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