Clinical Study to Explore the Efficacy of ACT-129968 in Patients With Partly Controlled Asthma

Study Overview
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Brief Summary
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This study will assess the efficacy and safety of ACT-129968 in subjects with partly controlled asthma on reliever therapy only.

Official Title
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A Multi-center, Double-blind, Placebo-controlled, Parallel-group Study to Establish Proof-of-concept and Explore the Efficacy of Different Doses of ACT-129968 in Adult Patients With Partly Controlled Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: Placebo
* Drug: Setipiprant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent prior to any study-mandated procedure Males and females age 18 to 65 years Women of childbearing potential must use adequate contraception Presenting with a diagnosis of asthma according to GINA Guidelines Pre-bronchodilator forced expiratory volume in one second (FEV1) < / = 85% of patient's predicted normal value Reversibility of airway obstruction of > / = 12% and > / = 200mL from pre-bronchodilator FEV1 ACQ score > / = 1.5 Exclusion Criteria: History of life-threatening asthma Any asthma exacerbation requiring treatment with systemic corticosteroids within the last 3 months Ongoing or recent treatment with medication for allergic airway disease Smoking within the last year, or life-time consumption > / = 10 pack-years (e.g., 20 cigarettes/day for 10 years) History of chronic pulmonary disease (other than asthma), such as chronic obstructive pulmonary disease (COPD), fibrosis, tuberculosis or sarcoidosis Pregnant or lactating women Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced asthma Any hospital admission for asthma within the last 6 months Anti-IgE therapy at any time check/update interventions by explicitely writing the experimental drug dosage in the interventions description Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Setipiprant - Dose 1<br>100 mg b.i.d. | Drug: Setipiprant<br>* ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily<br>* Other names: ACT-129968;|
| Experimental: Setipiprant - Dose 2<br>500 mg b.i.d. | Drug: Setipiprant<br>* ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily<br>* Other names: ACT-129968;|
| Experimental: Setipiprant - Dose 3<br>1,000 mg b.i.d | Drug: Setipiprant<br>* ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily<br>* Other names: ACT-129968;|
| Placebo Comparator: Matching Placebo<br>Oral placebo | Drug: Placebo<br>* Matching placebo administered orally twice daily<br>* Other names: matching placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo |  | Baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control |  | Baseline to 12 weeks |