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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04882124




Registration number
NCT04882124
Ethics application status
Date submitted
28/04/2021
Date registered
11/05/2021

Titles & IDs
Public title
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD
Scientific title
A 12-week Randomized, participant-and Investigator-blinded, Placebo-controlled, Parallel Group Study to Explore the Efficacy, Pharmacodynamics, Safety, and Pharmacokinetics of Two Doses of Inhaled CSJ117 in Adults With Chronic Obstructive Pulmonary Disease (COPD)
Secondary ID [1] 0 0
CCSJ117B12201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CSJ117
Treatment: Drugs - Placebo

Experimental: CSJ117 8mg - Intervention: Drug: CSJ117

Experimental: CSJ117 4mg - Intervention: Drug: CSJ117

Placebo comparator: CSJ117 Placebo - Intervention: Drug: Placebo


Treatment: Drugs: CSJ117
CSJ117 (4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device.

Treatment: Drugs: Placebo
Placebo inhaled once daily for 12 weeks. Delivered via Concept1 device
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in E-RS score
Timepoint [1] 0 0
Baseline, 12 weeks
Secondary outcome [1] 0 0
Change from baseline in CAT score
Timepoint [1] 0 0
Baseline, 12 weeks
Secondary outcome [2] 0 0
Change from baseline in SGRQ-C score
Timepoint [2] 0 0
Baseline, 12 weeks
Secondary outcome [3] 0 0
Response in E-RS in total score decrease from baseline
Timepoint [3] 0 0
Baseline, 12 weeks
Secondary outcome [4] 0 0
Response in CAT in total score decrease from baseline
Timepoint [4] 0 0
Baseline, 12 weeks
Secondary outcome [5] 0 0
Response in SGRQ-C in total score decrease from baseline
Timepoint [5] 0 0
Baseline, 12 weeks
Secondary outcome [6] 0 0
Change from baseline in trough FEV1 after 2, 6, and 12 weeks of treatment
Timepoint [6] 0 0
Baseline, 2, 6 and 12 weeks
Secondary outcome [7] 0 0
Puffs of rescue medication per day
Timepoint [7] 0 0
12 weeks
Secondary outcome [8] 0 0
Time to COPD exacerbations via EXACT
Timepoint [8] 0 0
12 weeks
Secondary outcome [9] 0 0
Rate and severity of COPD exacerbations via EXACT
Timepoint [9] 0 0
12 weeks
Secondary outcome [10] 0 0
Time to COPD exacerbations via HCRU
Timepoint [10] 0 0
12 weeks
Secondary outcome [11] 0 0
Rate and severity of COPD exacerbations via HCRU
Timepoint [11] 0 0
12 weeks
Secondary outcome [12] 0 0
Pre-dose trough concentration (Ctrough) of CSJ117
Timepoint [12] 0 0
12 weeks
Secondary outcome [13] 0 0
Accumulation ratio (Racc) of CSJ117
Timepoint [13] 0 0
12 weeks
Secondary outcome [14] 0 0
Measuring anti-drug antibodies
Timepoint [14] 0 0
12 weeks

Eligibility
Key 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
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/09/2022
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Novartis Investigative Site - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Louisiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Czechia
State/province [6] 0 0
Czech Republic
Country [7] 0 0
Hungary
State/province [7] 0 0
Balassagyarmat
Country [8] 0 0
Hungary
State/province [8] 0 0
Godollo
Country [9] 0 0
Hungary
State/province [9] 0 0
Szeged
Country [10] 0 0
Japan
State/province [10] 0 0
Aichi
Country [11] 0 0
Japan
State/province [11] 0 0
Ibaraki

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04882124