A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis

NCT ID: NCT04881461

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 445 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-10
• Study Completion Date: 2023-09-26

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.

Conditions

Allergy

Keywords

Allergic rhinoconjunctivitis; Adults; Grass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

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.

Group Type: EXPERIMENTAL

5-grass mix SLIT-drops

Intervention Type: DRUG

Sublingual allergy immunotherapy drops, for daily administration

Interventions

5-grass mix SLIT-drops

Sublingual allergy immunotherapy drops, for daily administration

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

SLIToneULTRA

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syneos Health

OTHER

Sponsor Role: collaborator

ALK-Abelló A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Guilleminault, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Hôpital Larrey

Locations

Fakultni Nemocnice u Sv. Anny - FNUSA

Brno, , Czechia

Ambulance alergologie a klinicke imunologie - Ceske Budejovice

České Budějovice, , 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, , Czechia

North Estonia Medical Centre Foundation

Tallinn, , Estonia

Hopital Privé de la Loire

Loiré, Saint-Étienne, France

Cabinet medical

Fenouillet, , France

Cabinet medical

Hyères, , France

Cabinet medical

Joué-lès-Tours, , France

Cabinet medical

Paris, , France

Cabinet médical

Rezé, , France

Cabinet medical

Saint-Quentin, , France

Nouvel Hopital Civil

Strasbourg, , France

CHU Hôpital Larrey

Toulouse, , France

M & M Centrs LTD

Ādaži, , Latvia

Balvu and Gulbenes hospital union

Balvi, , Latvia

Daugavpils Regional hospital, Outpatient clinic

Daugavpils, , Latvia

Vevere Viktorija - Doctor's Practice in Pneumology and Allergology

Rēzekne, , Latvia

Ozola Inese - Family doctor's practice

Riga, , Latvia

The Centre of Investigation and Treatment of Allergic Diseases

Riga, , Latvia

JSC Ausros Medicinos Centras

Kaunas, , Lithuania

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, , Lithuania

JSC Inlita, Klaipedos CTC

Klaipėda, , Lithuania

JSC Seimos gydytojas

Vilnius, , Lithuania

JSC Center of Innovative Allergology

Vilnius, , Lithuania

JSC INLITA, Santaros CTC

Vilnius, , Lithuania

Allergy Clinic JSC Perspektyvos

Vilnius, , Lithuania

JSC Center for Diagnosis and Treatment of Allergic Diseases

Vilnius, , Lithuania

Snzoz Alergologia Plus Ośrodek Diagnostyki i Terapii Uczuleń

Poznan, Greater Poland Voivodeship, Poland

Grażyna Pulka Centrum Medyczne ALL-MED

Krakow, Lesser Poland Voivodeship, Poland

Alergo-Med Specjalistycza Przychodnia Lekarska Sp. zo.o.

Tarnów, Maopolskie, Poland

Indywidualna Specjalistyczna Praktyka Lekarska Anna Latos

Kielce, , Poland

Centrum Usług Medycznych Dyga-Med

Krakow, , Poland

Grażyna Jasieniak-Pinis ATOPIA NZOZ Poradnie Specjalistyczne

Krakow, , Poland

Barbara Rewerska Diamond Clinic

Krakow, , Poland

Specjalistyczna Przychodnia Alergologiczna Centrum Alergologii

Lublin, , Poland

Centrum Alergologii T.Hofman Sp. Z o.o.

Poznan, , Poland

Snzoz Imedica

Poznan, , Poland

Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz

Rzeszów, , Poland

Gabinet Lekarski Bozena Kubicka-Kozik

Tomaszów Mazowiecki, , Poland

ALL-MED. Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy. Marek Jutel.

Wroclaw, , Poland

NZOZ Centrum Usług Medycznych Proximum Sp. z o.o.

Wroclaw, , Poland

Lekarze Specjaliści Malolepszy i Partnerzy

Wroclaw, , Poland

Countries

Czechia; Estonia; France; Latvia; Lithuania; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-000455-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SU-G-01

Identifier Type: -

Identifier Source: org_study_id