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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 day 1 through week 28
Awards & highlights
Study Summary
This trial will test whether a new drug is safe and effective for people with a lung disease called sarcoidosis.
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.Check my eligibility
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.See study design
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 ~ day 1 through week 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through week 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Forced Vital Capacity
Secondary outcome measures
Composite index of pulmonary physiology and exercise capacity
Exercise capacity
Pharmacokinetics of CMK389 maximum concentration (Cmax)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CMK389Experimental Treatment1 Intervention
CMK389
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CMK389
2021
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,325 Total Patients Enrolled
1 Trials studying Sarcoidosis
40 Patients Enrolled for Sarcoidosis
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Eligibility Criteria:
This trial includes the following eligibility 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.You have been taking methotrexate or azathioprine for more than 6 months before the screening.You can do a lung function test accurately following specific guidelines.You have had pancreatitis in the past.You have a type of lung problem called pulmonary hypertension that needs medicine to treat.If you have a heart condition called cardiac sarcoidosis that needs treatment, you cannot participate. If it's not active or stable and doesn't need treatment, you can join the study.You have been diagnosed with neurosarcoidosis.Your body mass index (BMI) must be between 18 and 46.You have severe difficulty breathing, rated as 3 or higher on the breathing difficulty scale.You have taken certain medications within the 12 weeks before screening.You cannot have a FDG-PET scan due to severe fear of enclosed spaces or uncontrolled diabetes.Your body mass index (BMI) must be between 18 and 46. You can calculate your BMI by dividing your weight in kilograms by the square of your height in meters.You have a history of heart electrical activity problems that could be risky for participating in the study.You have been diagnosed with Lofgren's syndrome.Your most recent chest x-ray taken within the last year or during screening shows specific stages of a lung condition called Scadding.You have been taking between 5 to 15 milligrams of prednisone or a similar medication every day for at least 6 months before being screened for the study.You have received treatment with rituximab, canakinumab, anakinra, or tocilizumab before.You are currently using any inhaled substances like tobacco, marijuana products, or vaping devices, except for prescribed inhalers or nebulizers for pulmonary sarcoidosis.Your lung function is less than half of what is expected for someone of your age and size.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: CMK389
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many applicants are currently being considered for inclusion in this trial?
"Affirmative. The information found on clinicaltrials.gov indicates that enrollment for this study is still open, having first been posted on September 23rd 2020 and most recently updated November 2nd 2022. 66 individuals need to be recruited from 11 different sites."
Answered by AI
What are the qualifications essential to participate in this trial?
"Eligible individuals who hope to join this clinical trial must have a diagnosis of sarcoidosis and pulmonary, while also falling within the age bracket of 18 and 75. Sixty-six people will be accepted in total."
Answered by AI
Is there still a possibility to join this exploration?
"This clinical trial is still open to applicants, as indicated by the information posted on clinicaltrials.gov. The study initially went up for review on September 23rd 2020 and was last modified November 2nd 2022."
Answered by AI
Are individuals aged 50 and above being considered as participants in this clinical trial?
"This medical trial is searching for participants aged between 18 and 75."
Answered by AI
How many centers are currently conducting this experiment?
"At the moment, this medical study is running at 11 sites. These include Philadelphia, Denver and Chicago in addition to 8 other cities. To avoid any unnecessary travel strains, it may be beneficial for participants to choose a site that's closest to them."
Answered by AI
What hazards may be associated with CMK389 for individuals?
"CMK389's safety was graded at 2 on our scale, as this Phase 2 trial has amassed some data to support its secure usage yet lacks any evidence of efficacy."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
Georgia
How old are they?
18 - 65
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
How responsive is this trial?
Most responsive sites:
- Novartis Investigative Site: < 48 hours
Typically responds via
Email
Average response time
- < 2 Days
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