Study of effect of CSJ117 on symptoms, pharmacodynamics and safety in patients with COPD

Phase 1

Conditions: Chronic Obstructive Pulmonary Disease
MedDRA version: 21.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2021-000692-36-DE

Lead Sponsor: ovartis Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 300

Inclusion Criteria

--Male and female COPD patients aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
--Current or ex-smokers who have a smoking history of at least 10 pack years
--Patients who have been treated with a triple combination of LABA/LAMA/ICS for the last 3 months prior to screening
--Patients with a documented diagnosis of COPD for at least 1 year prior to screening visit

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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

--Patients with a past or current medical history of asthma
--Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection in the 4 weeks prior to screening, or hospitalization between screening and prior to treatment.
--Use of other investigational drugs (approved or unapproved) within 30 days or 5 half-lives prior to screening, or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics),
whichever is longer; or longer if required by local regulations
--Pregnant or nursing (lactating) women, and women of childbearing potential not willing to use acceptable effective methods of contraception during study participation
-Patients with a body mass index (BMI) of more than 40 kg/m2

Other protocol-defined exclusion criteria may apply

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of CSJ117 on disease/symptom burden after 12 weeks of treatment;Secondary Objective: --To assess the effect of CSJ117 on disease/symptom burden<br>--To assess the number and percentage of patients who respond to treatment with CSJ117 with respect to improvement of symptoms<br>--To assess the effect of CSJ117 on lung function<br>--To assess the effect of CSJ117 on use of rescue medication (SABA)<br>--To assess the effect of CSJ117 on COPD exacerbations<br>--To characterize the systemic PK profile of CSJ117 after administration of multiple inhaled doses<br>--To assess the immunogenicity of multiple dose administrations of CSJ117 over 12 weeks<br>--To assess the safety of two doses of CSJ117 once daily, compared with placebo, with respect to (serious) adverse events (AE), electrocardiograms (ECGs), vital signs and laboratory tests<br>;Primary end point(s): Change from baseline in E-RS score;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): --Change from baseline in CAT<br>--Change from baseline in SGRQ-C<br>--Response in E-RS in total score decrease from baseline<br>--Response in CAT in total score decrease from baseline<br>--Response in SGRQ-C in total score decrease from baseline<br>--Change from baseline in lung function as assessed in spirometry<br>--Puffs of rescue medication per day<br>--Time to COPD exacerbations via EXACT<br>--Rate and severity of COPD exacerbations via EXACT<br>--Time to COPD exacerbations via HCRU<br>--Rate and severity of COPD exacerbations via HCRU<br>--Pre-dose trough concentration (Ctrough) of CSJ117<br>--Accumulation ratio (Racc) of CSJ117<br>--Measuring anti-drug antibodies;Timepoint(s) of evaluation of this end point: 12 weeks

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