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

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.

Study Overview

• Status: Completed
• Conditions: Allergy
• Intervention / Treatment: Drug: Placebo; Drug: 5-grass mix SLIT-drops

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 Type: Interventional
• Enrollment (Actual): 445
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 65691
    • Fakultni Nemocnice u Sv. Anny - FNUSA
  • Jablonec Nad Nisou, Czechia, 46601
    • Alergopraktik s.r.o.
  • Jihlava, Czechia, 58601
    • Allergology Jihlava
  • Liberec, Czechia, 46001
    • Alergologicka Ambulance - Liberec
  • Litomyšl, Czechia, 570 01
    • Alergomyšl s.r.o
  • Pardubice, Czechia, 53002
    • Acredula Benedicta s.r.o.
  • Trutnov, Czechia, 54101
    • MUJ ALERGOLOG s.r.o.
  • Tábor, Czechia, 39002
    • KASMED s.r.o.
  • České Budějovice, Czechia, 37001
    • Ambulance alergologie a klinicke imunologie - Ceske Budejovice
• Estonia
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation
• France
  • Fenouillet, France, 31150
    • Cabinet Médical
  • Hyeres, France, 83400
    • Cabinet Médical
  • Joué-lés-Tours, France, 37300
    • Cabinet Médical
  • Paris, France, 75012
    • Cabinet Médical
  • Rezé, France, 44400
    • Cabinet Médical
  • Saint-Quentin, France, 02100
    • Cabinet Médical
  • Strasbourg, France, 67091
    • Nouvel Hopital Civil
  • Toulouse, France, 31059
    • CHU Hôpital Larrey
  • Saint-Étienne
    • Loiré, Saint-Étienne, France, 42100
      • Hôpital privé de la Loire
• Latvia
  • Balvi, Latvia, LV-4501
    • Balvu and Gulbenes hospital union
  • Daugavpils, Latvia, LV-5401
    • Daugavpils Regional Hospital, Outpatient Clinic
  • Riga, Latvia, LV-1003
    • Ozola Inese - Family doctor's practice
  • Riga, Latvia, LV-1003
    • The Centre of Investigation and Treatment of Allergic Diseases
  • Rēzekne, Latvia, LV-4601
    • Vevere Viktorija - Doctor's Practice in Pneumology and Allergology
  • Ādaži, Latvia, LV-2164
    • M & M Centrs Ltd
• Lithuania
  • Kaunas, Lithuania, 50161
    • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
  • Kaunas, Lithuania, 49387
    • JSC Ausros Medicinos Centras
  • Klaipėda, Lithuania, 92231
    • JSC Inlita, Klaipedos CTC
  • Vilnius, Lithuania, 01118
    • JSC Seimos gydytojas
  • Vilnius, Lithuania, 06256
    • JSC Center of Innovative Allergology
  • Vilnius, Lithuania, 08406
    • JSC INLITA, Santaros CTC
  • Vilnius, Lithuania, 08564
    • Allergy Clinic JSC Perspektyvos
  • Vilnius, Lithuania, LT-08109
    • JSC Center for Diagnosis and Treatment of Allergic Diseases
• Poland
  • Kielce, Poland, 25-017
    • Indywidualna Specjalistyczna Praktyka Lekarska Anna Latos
  • Kraków, Poland, 31-033
    • Centrum Usług Medycznych Dyga-Med
  • Kraków, Poland, 31-159
    • Grażyna Jasieniak-Pinis ATOPIA NZOZ Poradnie Specjalistyczne
  • Kraków, Poland, 33-559
    • Barbara Rewerska Diamond Clinic
  • Lublin, Poland, 20-552
    • Specjalistyczna Przychodnia Alergologiczna Centrum Alergologii
  • Poznań, Poland, 60-537
    • Snzoz Imedica
  • Poznań, Poland, 60-214
    • Centrum Alergologii T.Hofman Sp. Z o.o.
  • Rzeszów, Poland, 35051
    • Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz
  • Tomaszów Mazowiecki, Poland, 97-200
    • Gabinet Lekarski Bozena Kubicka-Kozik
  • Wrocław, Poland, 53-201
    • ALL-MED. Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy. Marek Jutel.
  • Wrocław, Poland, 53-428
    • NZOZ Centrum Usług Medycznych Proximum Sp. z o.o.
  • Wrocław, Poland, 54-239
    • Lekarze Specjaliści Malolepszy i Partnerzy
  • Malopolskie
    • Kraków, Malopolskie, Poland, 30-033
      • Grażyna Pulka Centrum Medyczne ALL-MED
  • Maopolskie
    • Tarnów, Maopolskie, Poland, 33-100
      • Alergo-Med Specjalistycza Przychodnia Lekarska Sp. zo.o.
  • Wielkopolskie
    • Poznań, Wielkopolskie, Poland, 60-693
      • Snzoz Alergologia Plus Ośrodek Diagnostyki i Terapii Uczuleń

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Glycerol, carbonate, sodium chloride One single-dose container (0.5 ml) once daily	Drug: Placebo; Placebo
Experimental: 5-grass mix SLIT-drops; 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.	Drug: 5-grass mix SLIT-drops; Sublingual allergy immunotherapy drops, for daily administration; Other Names: SLIToneULTRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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).	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: ALK-Abelló A/S
• Collaborators: Syneos Health
• Investigators: Principal Investigator: Laurent Guilleminault, MD, CHU Hôpital Larrey

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): September 26, 2023
• Study Completion (Actual): September 26, 2023

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Adults; Allergic rhinoconjunctivitis; Grass
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Conjunctivitis
• Other Study ID Numbers: SU-G-01; 2020-000455-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No