Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis
A Subject and Investigator Blinded, Randomized, Placebo-controlled, Repeat-dose, Multicenter Study to Investigate Efficacy, Safety, and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis
1 other identifier
interventional
62
6 countries
22
Brief Summary
The purpose of this proof of concept study was to determine whether CMK389 displays the safety and efficacy profile to support further development in chronic pulmonary sarcoidosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2020
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2019
CompletedFirst Posted
Study publicly available on registry
August 21, 2019
CompletedStudy Start
First participant enrolled
September 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2023
CompletedResults Posted
Study results publicly available
October 2, 2024
CompletedApril 13, 2025
April 1, 2025
3 years
August 20, 2019
September 9, 2024
April 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Percent Predicted FVC From Baseline to 16 Weeks of Treatment
To assess the effect of CMK389 compared to placebo after 16 weeks of treatment on spirometry (Forced Vital Capacity). Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Percent predicted FVC is the percentage of the age, height and gender adjusted predicted value.
Baseline, Week 16
Secondary Outcomes (8)
Number of Participants Who Had an Increase in Steroid Usage From Baseline to 16 Weeks of Treatment
Baseline, Week 16
Number of Participants Who Deteriorate From Baseline to 16 Weeks of Treatment
Baseline, Week 16
Percent Change in [18F]-FDG-PET/CT (SUVmax and SUVmean) From Baseline to 16 Weeks of Treatment
Baseline, Week 16
The Observed Serum Concentration Following CMK389 Administration at End of Infusion
Post 1 hour: Day 1, Day 29, Day 57, Day 85
Pre-dose Trough Concentration (Ctrough) of CMK389
Pre-dose: Day 1, Day 29, Day 57, Day 85
- +3 more secondary outcomes
Study Arms (2)
CMK389
EXPERIMENTALCMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses
Placebo
PLACEBO COMPARATORPlacebo i.v. every 4 weeks for a total of 4 doses
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must have a body mass index (BMI) at screening within the range of 18 - 46 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2
- Biopsy proven pulmonary sarcoidosis diagnosed \> 1 year prior to screening
- Scadding stage II, III or IV as determined by the most recent chest x-ray obtained within 12 months prior to screening or at screening (confirmed by the Investigator)
- HRCT extent of fibrosis \<20% (confirmed by the central imaging reader) at screening
- Treatment with 5-15 mg/day prednisone (or prednisone oral equivalents) for ≥ 6 months prior to screening.
- Co-medication with methotrexate or azathioprine for ≥ 6 months prior to screening (Note: hydroxychloroquine is allowed as background therapy but not required)
- Able to perform reliable, reproducible pulmonary function test maneuvers per American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
You may not qualify if:
- Diagnosis of significant pulmonary hypertension (WHO group 5) requiring pharmacological treatment
- Active cardiac sarcoidosis requiring treatment. Inactive cardiac sarcoidosis or stable cardiac sarcoidosis not requiring treatment are permissible.
- A known diagnosis of neurosarcoidosis
- Forced vital capacity (FVC) \<50% of predicted at screening (central read)
- Modified British Medical Research Council (mMRC) dyspnea scale ≥ 3 at screening
- Concomitant treatment with leflunomide, cyclophosphamide, mycophenolate, infliximab, etanercept, adalimumab, golimumab, ustekinumab, roflumilast, pentoxifylline, and abatacept within 12 weeks of screening
- Prior treatment with rituximab, canakinumab, anakinra, and tocilizumab
- Current use of any inhaled substance, including but not limited to tobacco, marijuana products and use of electronic cigarette or vaping device, and excluding inhalers or nebulizers prescribed for pulmonary sarcoidosis
- Any conditions or significant medical problems which in the opinion of the investigator and in consultation with the sponsor, immunocompromises the patient and/or places the patient at unacceptable risk for immunomodulatory therapy
- Contraindication to FDG-PET scan investigations such as severe claustrophobia or uncontrolled diabetes
- History or current diagnosis of ECG abnormalities not due to Cardiac Sarcoidosis and indicating significant risk of safety for patients participating in the study
- A diagnosis of Lofgren's syndrome
- A history of pancreatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Novartis Investigative Site
Birmingham, Alabama, 35294-3300, United States
Univ of Florida College of Medicine x
Gainesville, Florida, 32610, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7330, United States
John Hopkins Asthma And Alrgy Cntr
Baltimore, Maryland, 21224, United States
Icahn School Of Med At Mount Sinai .
New York, New York, 10029, United States
East Carolina University .
Greenville, North Carolina, 27858, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Novartis Investigative Site
Brno, 625 00, Czechia
Novartis Investigative Site
Olomouc, 779 00, Czechia
Novartis Investigative Site
Aarhus N, 8200, Denmark
Novartis Investigative Site
Hellerup, 2900, Denmark
Novartis Investigative Site
Odense C, DK 5000, Denmark
Novartis Investigative Site
Heidelberg, Baden-Wurttemberg, 69126, Germany
Novartis Investigative Site
Essen, 45147, Germany
Novartis Investigative Site
Frankfurt, 60596, Germany
Novartis Investigative Site
Hamburg, 20246, Germany
Novartis Investigative Site
Hanover, 30625, Germany
Novartis Investigative Site
Bialystok, 15-044, Poland
Novartis Investigative Site
Lodz, 90 153, Poland
Novartis Investigative Site
Warsaw, 01-138, Poland
Novartis Investigative Site
Edinburgh, EH1 1BE, United Kingdom
Novartis Investigative Site
London, SW3 6PH, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2019
First Posted
August 21, 2019
Study Start
September 23, 2020
Primary Completion
September 19, 2023
Study Completion
December 12, 2023
Last Updated
April 13, 2025
Results First Posted
October 2, 2024
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
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.