Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Novartis Pharmaceuticals
+41613241111


Novartis Pharmaceuticals
1-888-669-6682
Novartis.email@novartis.com


Study Location:

Novartis Investigative Site
Edinburgh


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Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis

Recruiting

Open to: All Genders

Age: 18 Years - 75 Years

Medical Conditions

Pulmonary Sarcoidosis


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




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.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Sep 2020

Apr 2023

Interventional

Intervention Type : Drug
Intervention Description : single i.v. dose every 4 weeks

Intervention Arm Group : CMK389

Intervention Type : Drug
Intervention Description : single i.v. dose every 4 weeks

Intervention Arm Group : Placebo

You can take part if:


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




You may not be able to take part if:

This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Novartis Investigative Site
    Edinburgh

Novartis Pharmaceuticals
1-888-669-6682
Novartis.email@novartis.com


Novartis Pharmaceuticals
+41613241111



The study is sponsored by Novartis Pharmaceuticals



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for Trial ID: NCT04064242

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