A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis

NCT04881461 | Completed Phase 3 Results

• 2 other identifiers: SU-G-012020-000455-12
• Study Type: interventional
• Target: 445
• Locations: 6 countries
• Sites: 48

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.

Conditions

Allergy

Keywords

Allergic rhinoconjunctivitis; Adults; Grass

Outcome Measures

Primary Outcomes (1)

• Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS)

  The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.

  During the 2nd PGPS (14 days)

Secondary Outcomes (15)

• Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Peak Grass Pollen Season (PGPS)

  During the 2nd PGPS (14 days)

• Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Peak Grass Pollen Season (PGPS)

  During the 1st PGPS (14 days)

• Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Peak Grass Pollen Season (PGPS)

  During the 1st PGPS (14 days)

• Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Entire Grass Pollen Season (EGPS)

  During the 1st EGPS (observed mean duration of approximately 8 weeks)

• Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Entire Grass Pollen Season (EGPS)

  During the 2nd EGPS (observed mean duration of approximately 9 weeks)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

5-grass mix SLIT-drops

EXPERIMENTAL

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

Interventions

5-grass mix SLIT-drops DRUG

Sublingual allergy immunotherapy drops, for daily administration

Also known as: SLIToneULTRA

5-grass mix SLIT-drops

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ALK-Abelló A/S: lead
• Syneos Health: collaborator

Study Sites (48)

Fakultni Nemocnice u Sv. Anny - FNUSA

Brno, 65691, Czechia

Location

Ambulance alergologie a klinicke imunologie - Ceske Budejovice

České Budějovice, 37001, Czechia

Location

Alergopraktik s.r.o.

Jablonec nad Nisou, 46601, Czechia

Location

Allergology Jihlava

Jihlava, 58601, Czechia

Location

Alergologicka Ambulance - Liberec

Liberec, 46001, Czechia

Location

Alergomyšl s.r.o

Litomyšl, 570 01, Czechia

Location

Acredula Benedicta s.r.o.

Pardubice, 53002, Czechia

Location

KASMED s.r.o.

Tábor, 39002, Czechia

Location

MUJ ALERGOLOG s.r.o.

Trutnov, 54101, Czechia

Location

North Estonia Medical Centre Foundation

Tallinn, 13419, Estonia

Location

Hopital Privé de la Loire

Loiré, Saint-Étienne, 42100, France

Location

Cabinet medical

Fenouillet, 31150, France

Location

Cabinet medical

Hyères, 83400, France

Location

Cabinet medical

Joué-lès-Tours, 37300, France

Location

Cabinet medical

Paris, 75012, France

Location

Cabinet médical

Rezé, 44400, France

Location

Cabinet medical

Saint-Quentin, 02100, France

Location

Nouvel Hopital Civil

Strasbourg, 67091, France

Location

CHU Hôpital Larrey

Toulouse, 31059, France

Location

M & M Centrs LTD

Ādaži, LV-2164, Latvia

Location

Balvu and Gulbenes hospital union

Balvi, LV-4501, Latvia

Location

Daugavpils Regional hospital, Outpatient clinic

Daugavpils, LV-5401, Latvia

Location

Vevere Viktorija - Doctor's Practice in Pneumology and Allergology

Rēzekne, LV-4601, Latvia

Location

Ozola Inese - Family doctor's practice

Riga, LV-1003, Latvia

Location

The Centre of Investigation and Treatment of Allergic Diseases

Riga, LV-1003, Latvia

Location

JSC Ausros Medicinos Centras

Kaunas, 49387, Lithuania

Location

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, 50161, Lithuania

Location

JSC Inlita, Klaipedos CTC

Klaipėda, 92231, Lithuania

Location

JSC Seimos gydytojas

Vilnius, 01118, Lithuania

Location

JSC Center of Innovative Allergology

Vilnius, 06256, Lithuania

Location

JSC INLITA, Santaros CTC

Vilnius, 08406, Lithuania

Location

Allergy Clinic JSC Perspektyvos

Vilnius, 08564, Lithuania

Location

JSC Center for Diagnosis and Treatment of Allergic Diseases

Vilnius, LT-08109, Lithuania

Location

Snzoz Alergologia Plus Ośrodek Diagnostyki i Terapii Uczuleń

Poznan, Greater Poland Voivodeship, 60-693, Poland

Location

Grażyna Pulka Centrum Medyczne ALL-MED

Krakow, Lesser Poland Voivodeship, 30-033, Poland

Location

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

Tarnów, Maopolskie, 33-100, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Anna Latos

Kielce, 25-017, Poland

Location

Centrum Usług Medycznych Dyga-Med

Krakow, 31-033, Poland

Location

Grażyna Jasieniak-Pinis ATOPIA NZOZ Poradnie Specjalistyczne

Krakow, 31-159, Poland

Location

Barbara Rewerska Diamond Clinic

Krakow, 33-559, Poland

Location

Specjalistyczna Przychodnia Alergologiczna Centrum Alergologii

Lublin, 20-552, Poland

Location

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

Poznan, 60-214, Poland

Location

Snzoz Imedica

Poznan, 60-537, Poland

Location

Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz

Rzeszów, 35051, Poland

Location

Gabinet Lekarski Bozena Kubicka-Kozik

Tomaszów Mazowiecki, 97-200, Poland

Location

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

Wroclaw, 53-201, Poland

Location

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

Wroclaw, 53-428, Poland

Location

Lekarze Specjaliści Malolepszy i Partnerzy

Wroclaw, 54-239, Poland

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Senior Director, Clinical Data Science, Global Clinical Development
• Organization: ALK-Abelló A/S

clinicaltrials@alk.net

+4545747576

Study Officials

• Laurent Guilleminault, MD

  CHU Hôpital Larrey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: May 11, 2021
• Study Start: May 10, 2021
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: December 16, 2024
• Results First Posted: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

LI (8); PL (15); ES (1); CZ (9); FR (9); LA (6)