Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis

Study Overview
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Brief Summary
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This study will assess the efficacy and safety of different doses of ACT-129968 in adult patients with seasonal allergic rhinitis, due to mountain cedar pollen.

Official Title
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A Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group, Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: ACT-129968
* Drug: ACT-129968
* Drug: Cetirizine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged 18 to 70 years. Clinical history of symptomatic seasonal allergic rhinitis associated with mountain cedar pollen for the last two years. Adequate exposure to mountain cedar pollen. Positive skin prick test to mountain cedar allergen within 12 months of screening. Sufficient nasal symptom score during a run-in period. Exclusion Criteria: Non-allergic rhinitis. Bacterial or viral respiratory tract infection. Chronic respiratory disorders. Asthma requiring treatment other than inhaled short-acting Beta2-agonists. Ocular infections or surgery, nasal obstruction, nasal biopsy or surgery, sinus surgery or perforation. Smoking within the last year. Ongoing or recent treatment for seasonal allergic rhinitis. Initiation of allergen immunotherapy within 6 months of screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational drug - Dose 1<br> | Drug: ACT-129968<br>* ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily<br>|
| Experimental: Investigational drug - Dose 2<br> | Drug: ACT-129968<br>* ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily<br>|
| Experimental: Investigational drug - Dose 3<br> | Drug: ACT-129968<br>* ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily<br>|
| Experimental: Investigational Drug - Dose 4<br> | Drug: ACT-129968<br>* ACT-129968 (Dose 4) & matching placebo administered orally once daily<br>|
| Other: Active Matching Reference<br> | Drug: Cetirizine<br>* Ceterizine administered once daily<br>|
| Placebo Comparator: Matching Placebo<br> | Drug: ACT-129968<br>* ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily<br>Drug: ACT-129968<br>* ACT-129968 (Dose 4) & matching placebo administered orally once daily<br>Drug: Cetirizine<br>* Ceterizine administered once daily<br>Drug: Placebo<br>* Matching placebo administered twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo |  | Baseline to week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate a change in Daytime Nasal Symptom Score while taking either Dose 1, Dose 2, or Dose 4 of ACT-129968 verses placebo. |  | Baseline to week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seasonal allergic rhinitis, SAR, Allergic rhinitis, Allergies