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-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-15
• Last Update Posted: 19 April 2022

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 at run-in or in up to two unscheduled
visits. If not demonstrated, historical information within 1 year prior to
screening may be used
6. ACQ-5 score of = 1.5 at screening and end of run-in visits.
7. 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, hepatitis B,
untreated and not cured 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