CMK389 for Sarcoidosis

Recruiting at 28 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

62 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called CMK389 to see if it is safe and effective. The drug is aimed at helping people with chronic pulmonary sarcoidosis, a long-term lung condition. Researchers want to find out if this new treatment can improve their symptoms.

Will I have to stop taking my current medications?

The trial requires that you continue taking prednisone and possibly methotrexate or azathioprine if you have been on them for at least 6 months. However, you must stop taking certain medications like leflunomide, cyclophosphamide, and others listed in the exclusion criteria at least 12 weeks before screening.

How is the drug CMK389 different from other sarcoidosis treatments?

CMK389 is unique because it is part of a new wave of drugs being tested specifically for sarcoidosis, unlike most current treatments which are often used off-label and not rigorously studied for this condition. This trial represents an effort to find more effective and targeted therapies beyond the standard corticosteroids, which can have significant side effects. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults with biopsy-proven chronic pulmonary sarcoidosis diagnosed over a year ago, who have been on low-dose prednisone or equivalent and possibly methotrexate or azathioprine for at least 6 months. They should have limited lung fibrosis, a BMI of 18-46 kg/m2, and be capable of performing reliable pulmonary function tests.

Inclusion Criteria

You were diagnosed with pulmonary sarcoidosis from a lung biopsy more than 1 year ago.

You have been taking 5-15 mg of prednisone or a similar medication every day for at least 6 months before the screening.

You have less than 20% fibrosis in your lungs, as confirmed by a special type of X-ray called HRCT.

Exclusion Criteria

You have had pancreatitis in the past.

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

You have a type of lung problem called pulmonary hypertension that needs medicine to treat.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CMK389 10 mg/kg or placebo intravenously every 4 weeks for a total of 4 doses

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CMK389
• Placebo

Trial Overview The study is testing the safety and effectiveness of CMK389 compared to a placebo in treating chronic pulmonary sarcoidosis. Participants will either receive CMK389 or an inactive substance without knowing which one they are getting.

Participant Groups

Group I: CMK389 Experimental Treatment 1 Intervention

CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses

Group II: Placebo Placebo Group 1 Intervention

Placebo i.v. every 4 weeks for a total of 4 doses

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

Over 50% of sarcoidosis patients require treatment, but current medications are often prescribed off-label due to a lack of rigorous studies, leading to reliance on corticosteroids that can have significant side effects.

There is renewed interest in developing new drugs for sarcoidosis, with several active randomized controlled trials aimed at assessing the safety and efficacy of these new treatments, highlighting the need to address challenges in drug development for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sarcoidosis: Updates on therapeutic drug trials and novel treatment approaches. Obi, ON., Saketkoo, LA., Russell, AM., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Sarcoidosis: Updates on therapeutic drug trials and novel treatment approaches. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Modulatory role of macrophage migration inhibitory factor on cytokines and clinical features of sarcoidosis. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

[New Pathogenetic Concepts and Early Pharmacological Studies in Sarcoidosis]. [2017]

4. Australia pubmed.ncbi.nlm.nih.gov

Sarcoidosis: a state of the art review from the Thoracic Society of Australia and New Zealand. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Sarcoidosis extent relates to molecular variability. [2018]