Clinical trial NCT04881461: A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Keywords: Allergic rhinoconjunctivitis
Adults
Grass
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2021-05-11
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS)
timeFrame: During the 2nd PGPS (14 days)
Secondary outcomes:
measure: Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Peak Grass Pollen Season (PGPS)
timeFrame: During the 2nd PGPS (14 days)
measure: Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Peak Grass Pollen Season (PGPS)
timeFrame: During the 1st PGPS (14 days)
measure: Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Peak Grass Pollen Season (PGPS)
timeFrame: During the 1st PGPS (14 days)
measure: Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Entire Grass Pollen Season (EGPS)
timeFrame: During the 1st EGPS (observed mean duration of approximately 8 weeks)
measure: Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Entire Grass Pollen Season (EGPS)
timeFrame: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
measure: Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Entire Grass Pollen Season (EGPS)
timeFrame: During the 1st EGPS (observed mean duration of approximately 8 weeks)
measure: Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Entire Grass Pollen Season (EGPS)
timeFrame: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
measure: Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Peak Grass Pollen Season (PGPS)
timeFrame: During the 1st PGPS (14 days)
measure: Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Peak Grass Pollen Season (PGPS)
timeFrame: During the 2nd PGPS (14 days)
measure: Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Entire Grass Pollen Season (EGPS)
timeFrame: During the 1st EGPS (observed mean duration of approximately 8 weeks)
measure: Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Entire Grass Pollen Season (EGPS)
timeFrame: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
measure: Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Peak Grass Pollen Season (PGPS)
timeFrame: During the 1st PGPS (14 days)
measure: Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Peak Grass Pollen Season (PGPS)
timeFrame: During the 2nd PGPS (14 days)
measure: Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Entire Grass Pollen Season (EGPS)
timeFrame: During the 1st EGPS (observed mean duration of approximately 8 weeks)
measure: Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Entire Grass Pollen Season (EGPS)
timeFrame: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Fakultni Nemocnice u Sv. Anny - FNUSA
city: Jablonec Nad Nisou
country: Czechia
facility: Alergopraktik s.r.o.
city: Jihlava
country: Czechia
facility: Allergology Jihlava
city: Liberec
country: Czechia
facility: Alergologicka Ambulance - Liberec
city: Litomyšl
country: Czechia
facility: Alergomyšl s.r.o
city: Pardubice
country: Czechia
facility: Acredula Benedicta s.r.o.
city: Trutnov
country: Czechia
facility: MUJ ALERGOLOG s.r.o.
city: Tábor
country: Czechia
facility: KASMED s.r.o.
city: České Budějovice
country: Czechia
facility: Ambulance alergologie a klinicke imunologie - Ceske Budejovice
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Loiré
country: France
facility: Hopital Privé de la Loire
state: Saint-Étienne
city: Fenouillet
country: France
facility: Cabinet medical
city: Hyeres
country: France
facility: Cabinet medical
city: Joué-lés-Tours
country: France
facility: Cabinet medical
city: Paris
country: France
facility: Cabinet medical
city: Rezé
country: France
facility: Cabinet médical
city: Saint-Quentin
country: France
facility: Cabinet medical
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
city: Toulouse
country: France
facility: CHU Hôpital Larrey
city: Balvi
country: Latvia
facility: Balvu and Gulbenes hospital union
city: Daugavpils
country: Latvia
facility: Daugavpils Regional hospital, Outpatient clinic
city: Riga
country: Latvia
facility: Ozola Inese - Family doctor's practice
city: Riga
country: Latvia
facility: The Centre of Investigation and Treatment of Allergic Diseases
city: Rēzekne
country: Latvia
facility: Vevere Viktorija - Doctor's Practice in Pneumology and Allergology
city: Ādaži
country: Latvia
facility: M & M Centrs LTD
city: Kaunas
country: Lithuania
facility: JSC Ausros Medicinos Centras
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos
city: Klaipėda
country: Lithuania
facility: JSC Inlita, Klaipedos CTC
city: Vilnius
country: Lithuania
facility: JSC Seimos gydytojas
city: Vilnius
country: Lithuania
facility: JSC Center of Innovative Allergology
city: Vilnius
country: Lithuania
facility: JSC INLITA, Santaros CTC
city: Vilnius
country: Lithuania
facility: Allergy Clinic JSC Perspektyvos
city: Vilnius
country: Lithuania
facility: JSC Center for Diagnosis and Treatment of Allergic Diseases
city: Kraków
country: Poland
facility: Grażyna Pulka Centrum Medyczne ALL-MED
state: Malopolskie
city: Tarnów
country: Poland
facility: Alergo-Med Specjalistycza Przychodnia Lekarska Sp. zo.o.
state: Maopolskie
city: Poznań
country: Poland
facility: Snzoz Alergologia Plus Ośrodek Diagnostyki i Terapii Uczuleń
state: Wielkopolskie
city: Kielce
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Anna Latos
city: Kraków
country: Poland
facility: Centrum Usług Medycznych Dyga-Med
city: Kraków
country: Poland
facility: Grażyna Jasieniak-Pinis ATOPIA NZOZ Poradnie Specjalistyczne
city: Kraków
country: Poland
facility: Barbara Rewerska Diamond Clinic
city: Lublin
country: Poland
facility: Specjalistyczna Przychodnia Alergologiczna Centrum Alergologii
city: Poznań
country: Poland
facility: Centrum Alergologii T.Hofman Sp. Z o.o.
city: Poznań
country: Poland
facility: Snzoz Imedica
city: Rzeszów
country: Poland
facility: Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz
city: Tomaszów Mazowiecki
country: Poland
facility: Gabinet Lekarski Bozena Kubicka-Kozik
city: Wrocław
country: Poland
facility: ALL-MED. Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy. Marek Jutel.
city: Wrocław
country: Poland
facility: NZOZ Centrum Usług Medycznych Proximum Sp. z o.o.
city: Wrocław
country: Poland
facility: Lekarze Specjaliści Malolepszy i Partnerzy
Study officials:
affiliation: CHU Hôpital Larrey
name: Laurent Guilleminault, MD
role: PRINCIPAL_INVESTIGATOR
References: