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Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis
Study Purpose
The purpose of this proof of concept study is to determine whether CMK389 displays the safety
and efficacy profile to support further development in chronic pulmonary sarcoidosis.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
18 Years - 75 Years
Gender
All
More Inclusion & Exclusion Criteria
Inclusion Criteria:
- Subjects must have a body mass index (BMI) at screening within the range of 18 - 46
kg/m2.
BMI = Body weight (kg) / [Height (m)]2.
- Biopsy proven pulmonary sarcoidosis diagnosed > 1 year prior to screening.
- Scadding stage II, III or IV as determined by the most recent chest x-ray obtained
within 12 months prior to screening or at screening (confirmed by the Investigator)
- HRCT extent of fibrosis <20% (confirmed by the central imaging reader) at screening.
- Treatment with 5-15 mg/day prednisone (or prednisone oral equivalents) for ≥ 6 months
prior to screening.
- Co-medication with methotrexate or azathioprine for ≥ 6 months prior to screening
(Note: hydroxychloroquine is allowed as background therapy but not required)
- Able to perform reliable, reproducible pulmonary function test maneuvers per American
Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Exclusion Criteria:
- Diagnosis of significant pulmonary hypertension (WHO group 5) requiring
pharmacological treatment.
- Active cardiac sarcoidosis requiring treatment.
Inactive cardiac sarcoidosis or stable
cardiac sarcoidosis not requiring treatment are permissible.
- A known diagnosis of neurosarcoidosis.
- Forced vital capacity (FVC) <50% of predicted at screening (central read)
- Modified British Medical Research Council (mMRC) dyspnea scale ≥ 3 at screening.
- Concomitant treatment with leflunomide, cyclophosphamide, mycophenolate, infliximab,
etanercept, adalimumab, golimumab, ustekinumab, roflumilast, pentoxifylline, and
abatacept within 12 weeks of screening.
- Prior treatment with rituximab, canakinumab, anakinra, and tocilizumab.
- Current use of any inhaled substance, including but not limited to tobacco, marijuana
products and use of electronic cigarette or vaping device, and excluding inhalers or
nebulizers prescribed for pulmonary sarcoidosis.
- 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.
- Contraindication to FDG-PET scan investigations such as severe claustrophobia or
uncontrolled diabetes.
- History or current diagnosis of ECG abnormalities not due to Cardiac Sarcoidosis and
indicating significant risk of safety for patients participating in the study.
- A diagnosis of Lofgren's syndrome.
- A history of pancreatitis.
Other protocol-defined inclusion/exclusion criteria may apply
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Novartis Pharmaceuticals
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
N/A
Principal Investigator Affiliation
N/A
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
Czechia, Denmark, Germany, Poland, United Kingdom, United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Sarcoidosis
Arms & Interventions
Arms
Experimental: CMK389
CMK389
Placebo Comparator: Placebo
Placebo
Interventions
Drug: - CMK389
single i.v. dose every 4 weeks
Drug: - Placebo
single i.v. dose every 4 weeks
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.