Novartis has partnered with the Foundation for Sarcoidosis Research for an exciting clinical trial. The purpose of this trial is to investigate a potential new drug, CMK389, which hopes to improve the ability of the lungs to work for patients with chronic pulmonary sarcoidosis.
Eligible participants in this study will either receive the study drug or a placebo through intravenous infusion (i.e. administered into a vein) every 4 weeks. A total of 4 doses will be given. A placebo looks just like the study drug but does not contain any active medication. As a double-blind study, neither participants nor investigators will know which patients receive CMK389 and which receive the placebo.
Run-in (3 visits over 6 weeks):
Eligible participants will stop using methotrexate and/or azathioprine. Two weeks after stopping use of these medications, participants will receive a full safety assessment.
- If there are no safety concerns, the participant will begin a steroid medication (prednisone or equivalent) titration. This means that the dose of your steroid medication will be slowly reduced.
- If there are safety concerns, the participant will not be able to participate in the study
Treatment (5 visits over 16 weeks):
Participant clinical status will be assessed to ensure safety in receiving study treatment. Eligible participants will be randomly assigned to receive either CMK389 or a placebo. Participants will be monitored during monthly visits for any adverse events (undesirable effects).
Safety Follow-Up (3 visits over 12 weeks)
This follow-up will consist of a physical exam, assessment of adverse events, and various lab samples. During this time, sarcoidosis treatment may be guided by the study doctor or resume with the patient’s own physician. If needed, the patient’s doctor can choose to change the patient’s steroid dosage and/or reintroduce methotrexate and/or azathioprine.
Extended Follow-Up (For Women of Childbearing Potential Only) (6 urine pregnancy tests at home over 24 weeks)
Women of Childbearing Potential will be followed-up with for an additional 24 weeks (40 weeks total after last treatment) in order to monitor any case of pregnancy.
What do Clinical Status Evaluations Typically Consist of?
A typical evaluation will include a 6-minute walk test, spirometry assessment, and a questionnaire. These tests serve as a way to ensure participant safety as well as mark clinical status.
What are Placebos Used for?
Placebos are necessary for ensuring that any treatment effects seen during the study are truly due to the study drug and not an external factor.
Why are Participants Randomly Selected for the Study Drug?
Randomization is used to avoid bias when assigning participants to their treatment group.
Why is this study double blinded?
Similar to randomization, blinding helps avoid (conscious and unconscious) biases that could potentially arise when aware of treatment assignments.
Who can participate in this study?
Potential participants should fulfill the following criteria:
- Be between the ages of 18 and 65 years
- Have a body mass index (BMI) within the range of 18-34 kg/m2
- Have biopsy proven pulmonary sarcoidosis diagnosed at least a year ago
- Be receiving 5-15 mg/day of prednisone (or equivalent steroid medications) for the last 6 months
- Be receiving methotrexate or azathioprine for the last 6 months
Potential participants who fulfill any of the following criteria may not be able to participate:
- Diagnosis of pulmonary hypertension
- Known diagnosis of cardiac sarcoidosis
- Known diagnosis of neurosarcoidosis
- Prior treatment with rituximab (Truxima®, Rituxan®), canakinumab (Ilaris®), anakinra (Kineret®), and tocilizumab (Actemra®)
- Current smokers, defined as inhaled use of tobacco products
- University of Florida
- Additional locations may be added
For more information on this study, eligibility requirements click here.
Find out if you qualify by taking this short survey: https://ct.gomohealth.care/Enrollment/sarc