Study of efficacy and safety of CSJ117 in patients with severe uncontrolled asthma

Phase 1

• Conditions: Asthma; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-004905-29-CZ
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-16
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 625

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 at least 1 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 12 weeks after last study drug treatment (end of follow up).
4. Patients with a history of immunodeficiency disease or hepatitis B or hepatitis C or HIV.
5. Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified