CMK389 for Sarcoidosis

No longer recruiting at 30 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must be taking: Prednisone, Methotrexate, Azathioprine

Must not be taking: Leflunomide, Cyclophosphamide, Mycophenolate, others

Disqualifiers: Pulmonary hypertension, Cardiac sarcoidosis, Neurosarcoidosis, others

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

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called CMK389, an experimental therapy, to determine its safety and effectiveness for individuals with chronic pulmonary sarcoidosis, a condition characterized by ongoing lung inflammation. Participants will receive either CMK389 or a placebo, administered through an IV every four weeks for four doses. Suitable candidates have had a lung biopsy confirming sarcoidosis for over a year, have been on prednisone for at least six months, and are also taking specific medications like methotrexate. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CMK389 is being tested for safety in treating the chronic lung disease sarcoidosis. Studies have examined its effects on patients, and results suggest that CMK389 is generally safe, with most patients not experiencing serious side effects. Some individuals might encounter mild side effects, but these are usually manageable.

CMK389 is currently in a Phase 2 trial, which focuses on assessing the treatment's safety and effectiveness. Although CMK389 has shown promise in earlier trials, further research is necessary to fully understand its safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for sarcoidosis?

Unlike the standard treatments for sarcoidosis, which often include corticosteroids and immunosuppressants, CMK389 works differently by targeting specific pathways involved in inflammation. Researchers are excited about CMK389 because it is administered intravenously and has the potential to offer a more targeted approach, potentially reducing the side effects associated with broad immunosuppression. This novel mechanism of action could provide a more effective and safer alternative for patients struggling with the chronic inflammation characteristic of sarcoidosis.

What evidence suggests that CMK389 might be an effective treatment for sarcoidosis?

Studies have shown that CMK389 works by blocking a specific protein in the immune system, potentially playing a role in chronic pulmonary sarcoidosis, a condition that causes lung inflammation. In early research, patients who received CMK389 experienced some improvement in their symptoms compared to those who received a placebo. In this trial, participants will receive either CMK389 or a placebo. These results suggest that CMK389 could be promising for treating this lung condition by affecting the immune response. However, further research is needed to confirm these findings. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04064242

NCT04064242 | Study of Efficacy, Safety and Tolerability of ... 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 ...

2. novctrd.com novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2426

Clinical Trial Results Summary CMK389 is a trial drug designed to block a protein in the immune system that may play a role in chronic pulmonary sarcoidosis. A placebo looks like the trial ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9596775/

Sarcoidosis: Updates on therapeutic drug trials and novel ... Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis. (2022). Available online at: https://www.clinicaltrials ...

4. ctv.veeva.com ctv.veeva.com/study/study-of-efficacy-safety-and-tolerability-of-cmk389-in-patients-with-chronic-pulmonary-sarcoidosis

Study of Efficacy, Safety and Tolerability of CMK389 in ... The purpose of this proof of concept study was to determine whether CMK389 displays the safety and efficacy profile to support further ...

5. novctrd.com novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18216

Sponsor Generic Drug Name Trial Indication(s) Protocol ... The primary objective of the trial was to assess the efficacy of CMK389 in participants with chronic pulmonary sarcoidosis. The secondary objectives of the ...

6. sigma.larvol.com sigma.larvol.com/product.php?e1=740670&tab=newstrac

CMK389 News For most patients receiving SACT, PORTs are more effective and safer than both Hickman and PICCs. Our findings suggest that most patients receiving SACT for ...