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A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis (Rhapsody)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04881461
Recruitment Status : Recruiting
First Posted : May 11, 2021
Last Update Posted : November 12, 2021
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
ALK-Abelló A/S

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
Allergy 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 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
Estimated Primary Completion Date : September 23, 2023
Estimated Study Completion Date : September 23, 2023

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 Name: SLIToneULTRA




Primary Outcome Measures :
  1. Average daily allergic rhinoconjunctivitis total combined score (TCS) during the 2nd PGPS (Peak Grass Pollen Season) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04881461


Contacts
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Contact: Clinical Project Manager +4545747576 clinicaltrials@alk.net

Locations
Show Show 45 study locations
Sponsors and Collaborators
ALK-Abelló A/S
Syneos Health
Investigators
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Principal Investigator: Laurent Guilleminault, MD CHU Hôpital Larrey
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Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT04881461    
Other Study ID Numbers: SU-G-01
2020-000455-12 ( EudraCT Number )
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: November 12, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Conjunctivitis
Conjunctival Diseases
Eye Diseases