For Healthcare Professionals

Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis


About the study

The purpose of this proof of concept study is to determine whether CMK389 displays the safety and efficacy profile to support further development in chronic pulmonary sarcoidosis.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. 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
  2. Biopsy proven pulmonary sarcoidosis diagnosed > 1 year prior to screening
  3. 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)
  4. HRCT extent of fibrosis <20% (confirmed by the central imaging reader) at screening
  5. Treatment with 5-15 mg/day prednisone (or prednisone oral equivalents) for ≥ 6 months prior to screening.
  6. Co-medication with methotrexate or azathioprine for ≥ 6 months prior to screening (Note: hydroxychloroquine is allowed as background therapy but not required)
  7. Able to perform reliable, reproducible pulmonary function test maneuvers per American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines


Exclusion Criteria:

  1. Diagnosis of significant pulmonary hypertension (WHO group 5) requiring pharmacological treatment
  2. Active cardiac sarcoidosis requiring treatment. Inactive cardiac sarcoidosis or stable cardiac sarcoidosis not requiring treatment are permissible.
  3. A known diagnosis of neurosarcoidosis
  4. Forced vital capacity (FVC) <50% of predicted at screening (central read)
  5. Modified British Medical Research Council (mMRC) dyspnea scale ≥ 3 at screening
  6. Concomitant treatment with leflunomide, cyclophosphamide, mycophenolate, infliximab, etanercept, adalimumab, golimumab, ustekinumab, roflumilast, pentoxifylline, and abatacept within 12 weeks of screening
  7. Prior treatment with rituximab, canakinumab, anakinra, and tocilizumab
  8. 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
  9. 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
  10. Contraindication to FDG-PET scan investigations such as severe claustrophobia or uncontrolled diabetes
  11. History or current diagnosis of ECG abnormalities not due to Cardiac Sarcoidosis and indicating significant risk of safety for patients participating in the study
  12. A diagnosis of Lofgren's syndrome
  13. A history of pancreatitis

Other protocol-defined inclusion/exclusion criteria may apply

pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Pulmonary Sarcoidosis

Age (in years)

18 - 75


Phase 2

Participants needed


Est. Completion Date

Jan 19, 2024

Treatment type



Novartis identifier


Study number


Understanding Clinical Trials

Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?


Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.