A study to explore the effect of different doses of ACT-129968 in adult patients with partly controlled asthma.

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. - CONTROL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011975-60-SE

Enrollment

412

Registered

2009-09-16

Start date

2010-09-30

Completion date

Unknown

Last updated

2012-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic asthma MedDRA version: 14.1 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: ACT-129968 Product Code: ACT-129968 Pharmaceutical Form: Capsule, hard Current Sponsor code: ACT-129968 Concentration unit: mg milligram(s) Concentration type: equal Concentration number

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Males and females aged 18 to 65 years. - Signed informed consent prior to any study-mandated procedure. - Women of childbearing potential must use adequate contraception. - Presenting with a diagnosis of asthma according to Global Initiative for Asthma (GINA) Guidelines. - Partially controlled asthma while using only rescue medication as needed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 412 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Pregnant or lactating women. - Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced asthma. - History of life-threatening asthma at any time, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures. - Any asthma exacerbation requiring treatment with systemic corticosteroids within the last 3 months. - Any hospital admission for asthma within the last 6 months. - Anti-IgE therapy (at any time). - Ongoing or recent treatment with medication for allergic airway disease (either prescribed or over-the-counter [OTC]) other than an inhaled beta2 agonist used solely as reliever therapy on an ‘as-needed’ basis. - Smoking within the last year, or life-time consumption of 10 pack-years e.g., 20 cigarettes/day for 10 years. - Treatment with investigational asthma controller biological agents (recombinant proteins or monoclonal antibodies) within 6 months prior to start of study drug.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the efficacy of ACT-129968 versus placebo on lung function.;Secondary Objective: - To explore the efficacy of different doses of ACT-129968 on lung function and symptoms of asthma. - To assess the tolerability and safety of ACT-129968. - To assess the pharmacokinetics (PK) of ACT-129968.;Primary end point(s): The primary endpoint is the change from baseline in FEV1 percentage of predicted (FEV1%oP) normal value. ;Timepoint(s) of evaluation of this end point: at 12 weeks	—

Measure

Time frame

Main Objective: To demonstrate the efficacy of ACT-129968 versus placebo on lung function.;Secondary Objective: - To explore the efficacy of different doses of ACT-129968 on lung function and symptoms of asthma. - To assess the tolerability and safety of ACT-129968. - To assess the pharmacokinetics (PK) of ACT-129968.;Primary end point(s): The primary endpoint is the change from baseline in FEV1 percentage of predicted (FEV1%oP) normal value. ;Timepoint(s) of evaluation of this end point: at 12 weeks

—

Countries

Australia, Bulgaria, Germany, Hungary, Israel, Poland, Russian Federation, Serbia, Singapore, South Africa, Sweden, Ukraine, United States

Contacts

Public ContactGlobal Medical Information

Actelion Pharmaceuticals Ltd.

medinfo_ch@actelion.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026