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Rhapsody: A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis

Sponsor
ALK-Abelló A/S (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04881461
Collaborator
Syneos Health (Other)
445
Enrollment
48
Locations
2
Arms
28.5
Anticipated Duration (Months)
9.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 5-grass mix SLIT-drops
  • Drug: Placebo
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
445 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 10, 2021
Anticipated Primary Completion Date :
Sep 23, 2023
Anticipated Study Completion Date :
Sep 23, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Average daily allergic rhinoconjunctivitis total combined score (TCS) during the 2nd PGPS (Peak Grass Pollen Season) [6 months]

      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.

    Secondary Outcome Measures

    1. Average score of weekly overall rhinitis quality of life questionnaire (RQLQ) during the 2nd PGPS (Peak Grass Pollen Season) [6 months]

      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.

    2. Average daily allergic rhinoconjunctivitis TCS during the 1st PGPS (Peak Grass Pollen Season) [6 months]

      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).

    3. Average score of weekly overall RQLQ during the 1st PGPS (Peak Grass Pollen Season) [6 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • ALK-Abelló A/S
    • Syneos Health

    Investigators

    • Principal Investigator: Laurent Guilleminault, MD, CHU Hôpital Larrey

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ALK-Abelló A/S
    ClinicalTrials.gov Identifier:
    NCT04881461
    Other Study ID Numbers:
    • SU-G-01
    • 2020-000455-12
    First Posted:
    May 11, 2021
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ALK-Abelló A/S
    Allergic rhinoconjunctivitis
    Adults
    Grass
    Additional relevant MeSH terms:
    Conjunctivitis

    Study Results

    No Results Posted as of Aug 15, 2022