EUCTR2019-004905-29-ITActive, not recruitingPhase 1
A 12-week, multicenter, randomized, double-blind, parallel-arm, placebo-controlled study to assess the efficacy and safety of CSJ117, when added to existing asthma therapy in patients =18 years of age with severe uncontrolled asthma. - CCSJ117A12201C
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- OVARTIS PHARMA AG
- Enrollment
- 335
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Diagnosed asthma
- •2. Male and female patients aged >18 and <75 years
- •3. Patients who have been treated with medium or high dose ICS plus LABA with up to 2 additional controller
- •4. Morning pre-BD FEV1 value of = 40% and = 85% of the predicted normal
- •5. A positive reversibility test
- •6. ACQ-5 score of = 1.5 at screening and end of run-in visits.
- •7. History of 1 or 2 asthma exacerbations within the 12 months prior to Screening Visit that required treatment with systemic corticosteroids (tablets, suspension or injection).
- •8. Other protocol-defined inclusion criteria may apply
- •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 562
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 63
Exclusion Criteria
- •1. Patients who have a cigarette smoking history of greater than 10 pack years or current smokers.
- •2. Pregnant or nursing (lactating) women
- •3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using specified methods of
- •contraception during dosing of study drug and one week after last study drug treatment
- •4. Patients with a history of immunodeficiency disease or hepatitis B or hepatitis C or HIV.
- •5. Other protocol-defined exclusion criteria may apply
Investigators
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