A Subject and Investigator Blinded, Randomized, Placebo-controlled, Repeat-dose, Multicenter Study to Investigate Efficacy, Safety, and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis

STATUS

Recruiting
End date

Dec 22, 2023
participants needed

66
sponsor

Novartis Pharmaceuticals

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Updated on 13 October 2022

See if I qualify

methotrexate

prednisone

hydroxychloroquine

azathioprine

pulmonary sarcoidosis

Summary

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.

Details

Condition	Pulmonary Sarcoidosis
Treatment	Placebo, CMK389
Clinical Study Identifier	NCT04064242
Sponsor	Novartis Pharmaceuticals
Last Modified on	13 October 2022

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Eligibility		Yes	No	Not Sure
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

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A Subject and Investigator Blinded, Randomized, Placebo-controlled, Repeat-dose, Multicenter Study to Investigate Efficacy, Safety, and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis