A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis

Allergy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04881461
• Other study ID #: SU-G-01
• Secondary ID: 2020-000455-12
• Status: Completed
• Phase: Phase 3
• Start date: May 10, 2021
• Est. completion date: September 26, 2023

Study information

• Verified date: February 2024
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: September 26, 2023
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergy
• Conjunctivitis

Intervention

Drug:
• 5-grass mix SLIT-drops
Sublingual allergy immunotherapy drops, for daily administration
• Placebo
Placebo

Locations

Country	Name	City	State
Czechia	Fakultni Nemocnice u Sv. Anny - FNUSA	Brno
Czechia	Ambulance alergologie a klinicke imunologie - Ceske Budejovice	Ceské Budejovice
Czechia	Alergopraktik s.r.o.	Jablonec Nad Nisou
Czechia	Allergology Jihlava	Jihlava
Czechia	Alergologicka Ambulance - Liberec	Liberec
Czechia	Alergomyšl s.r.o	Litomyšl
Czechia	Acredula Benedicta s.r.o.	Pardubice
Czechia	KASMED s.r.o.	Tábor
Czechia	MUJ ALERGOLOG s.r.o.	Trutnov
Estonia	North Estonia Medical Centre Foundation	Tallinn
France	Cabinet medical	Fenouillet
France	Cabinet medical	Hyeres
France	Cabinet medical	Joué-lés-Tours
France	Hopital Privé de la Loire	Loiré	Saint-Étienne
France	Cabinet medical	Paris
France	Cabinet médical	Rezé
France	Cabinet medical	Saint-Quentin
France	Nouvel Hopital Civil	Strasbourg
France	CHU Hôpital Larrey	Toulouse
Latvia	M & M Centrs LTD	Adaži
Latvia	Balvu and Gulbenes hospital union	Balvi
Latvia	Daugavpils Regional hospital, Outpatient clinic	Daugavpils
Latvia	Vevere Viktorija - Doctor's Practice in Pneumology and Allergology	Rezekne
Latvia	Ozola Inese - Family doctor's practice	Riga
Latvia	The Centre of Investigation and Treatment of Allergic Diseases	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kauno klinikos	Kaunas
Lithuania	JSC Ausros Medicinos Centras	Kaunas
Lithuania	JSC Inlita, Klaipedos CTC	Klaipeda
Lithuania	Allergy Clinic JSC Perspektyvos	Vilnius
Lithuania	JSC Center for Diagnosis and Treatment of Allergic Diseases	Vilnius
Lithuania	JSC Center of Innovative Allergology	Vilnius
Lithuania	JSC INLITA, Santaros CTC	Vilnius
Lithuania	JSC Seimos gydytojas	Vilnius
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Anna Latos	Kielce
Poland	Barbara Rewerska Diamond Clinic	Kraków
Poland	Centrum Uslug Medycznych Dyga-Med	Kraków
Poland	Grazyna Jasieniak-Pinis ATOPIA NZOZ Poradnie Specjalistyczne	Kraków
Poland	Grazyna Pulka Centrum Medyczne ALL-MED	Kraków	Malopolskie
Poland	Specjalistyczna Przychodnia Alergologiczna Centrum Alergologii	Lublin
Poland	Centrum Alergologii T.Hofman Sp. Z o.o.	Poznan
Poland	Snzoz Alergologia Plus Osrodek Diagnostyki i Terapii Uczulen	Poznan	Wielkopolskie
Poland	Snzoz Imedica	Poznan
Poland	Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz	Rzeszów
Poland	Alergo-Med Specjalistycza Przychodnia Lekarska Sp. zo.o.	Tarnów	Maopolskie
Poland	Gabinet Lekarski Bozena Kubicka-Kozik	Tomaszów Mazowiecki
Poland	ALL-MED. Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy. Marek Jutel.	Wroclaw
Poland	Lekarze Specjalisci Malolepszy i Partnerzy	Wroclaw
Poland	NZOZ Centrum Uslug Medycznych Proximum Sp. z o.o.	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
ALK-Abelló A/S	Syneos Health

Countries where clinical trial is conducted

Czechia,  Estonia,  France,  Latvia,  Lithuania,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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