What side effects are associated with this type of intervention?

Common treatments for sarcoidosis that target inflammatory pathways include methotrexate, mycophenolate mofetil, and TNF-alpha inhibitors like infliximab and adalimumab. Methotrexate can cause liver toxicity, lung injury, nausea, alopecia, and skin rash. Mycophenolate mofetil may lead to gastrointestinal disturbances, infections, and hematologic abnormalities. TNF-alpha inhibitors are associated with increased risk of infections, potential reactivation of latent tuberculosis, and possible development of lymphoproliferative disorders.

What prior FDA approvals exist?

The FDA has approved several treatments for sarcoidosis that target inflammatory pathways. Glucocorticoids, such as prednisone, are commonly used to reduce inflammation and granuloma formation. Additionally, immunosuppressive agents like methotrexate and mycophenolate mofetil are used for patients who do not respond to glucocorticoids. Tumor necrosis factor (TNF) inhibitors, such as infliximab and adalimumab, have also been approved for refractory sarcoidosis, targeting TNF-alpha to reduce inflammation. These treatments aim to manage the chronic inflammatory response characteristic of sarcoidosis.

What other types of research exist?

Promising novel alternatives to CMK389 for treating chronic pulmonary sarcoidosis in 2024 include TNF inhibitors (e.g., infliximab), IL-17 inhibitors (e.g., secukinumab, ixekizumab), and JAK inhibitors (e.g., tofacitinib, upadacitinib). These agents target inflammatory pathways and may help reduce granuloma formation and inflammation.

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CMK389 for Sarcoidosis

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post 1 hour: day 1, day 29, day 57, day 85

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects for CMK389 aren't listed here, common risks may include immune system reactions, potential organ inflammation due to immunomodulatory therapy, infusion-related responses, and general discomforts like fatigue or nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post 1 hour: day 1, day 29, day 57, day 85

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post 1 hour: day 1, day 29, day 57, day 85

This trial's timeline: 3 weeks for screening, Varies for treatment, and post 1 hour: day 1, day 29, day 57, day 85 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Percent Predicted FVC From Baseline to 16 Weeks of Treatment

Secondary study objectives

Change in 6-minute Walk Distance (6MWD) From Baseline to 16 Weeks of Treatment

Change in Diffusion Capacity of the Lung for Carbon Monoxide (DLCO) From Baseline to 16 Weeks of Treatment

Change in FEV1 From Baseline to 16 Weeks of Treatment

+5 more

Side effects data

From 2023 Phase 2 trial • 62 Patients • NCT04064242

13%

Fatigue

13%

Arthralgia

11%

Dyspnoea

11%

COVID-19

10%

Upper respiratory tract infection

10%

Headache

10%

Cough

Nausea

Chest pain

Back pain

Dizziness

Urinary tract infection

Nasopharyngitis

Myalgia

Hypertension

Pulmonary sarcoidosis

Diarrhoea

Cutaneous sarcoidosis

Blood creatinine increased

Ligament sprain

Haematuria

Blood alkaline phosphatase increased

Lipase increased

Squamous cell carcinoma of skin

Head injury

100%

80%

60%

40%

20%

Study treatment Arm

Placebo i.v

Total

CMK389 10 mg/kg i.v

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CMK389Experimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CMK389

2021

Completed Phase 2

~140

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for sarcoidosis primarily target inflammatory pathways to reduce granuloma formation and inflammation. Glucocorticoids suppress the immune response to decrease inflammation. Immunosuppressive agents like methotrexate and mycophenolate mofetil inhibit immune cell proliferation, reducing granuloma formation. TNF inhibitors, such as infliximab, block tumor necrosis factor-alpha, a key cytokine in inflammation and granuloma maintenance. These treatments are essential for managing symptoms, preventing disease progression, and improving quality of life for sarcoidosis patients by addressing the underlying inflammatory processes.

Minocycline for the treatment of sarcoidosis: is the mechanism of action immunomodulating or antimicrobial effect?Corticosteroid therapy in pulmonary sarcoidosis: a systematic review.