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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.

NCT04064242
Phase

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.

Novartis Investigative Site, Birmingham, Alabama

Status

Active, not recruiting

Address

Novartis Investigative Site

Birmingham, Alabama, 35294-3300

Novartis Investigative Site, Denver, Colorado

Status

Recruiting

Address

Novartis Investigative Site

Denver, Colorado, 80206

Novartis Investigative Site, Gainesville, Florida

Status

Completed

Address

Novartis Investigative Site

Gainesville, Florida, 32610

Novartis Investigative Site, Chicago, Illinois

Status

Withdrawn

Address

Novartis Investigative Site

Chicago, Illinois, 60611

Novartis Investigative Site, Kansas City, Kansas

Status

Completed

Address

Novartis Investigative Site

Kansas City, Kansas, 66160-7330

Novartis Investigative Site, Baltimore, Maryland

Status

Completed

Address

Novartis Investigative Site

Baltimore, Maryland, 21224

Novartis Investigative Site, Detroit, Michigan

Status

Active, not recruiting

Address

Novartis Investigative Site

Detroit, Michigan, 48202 2689

Novartis Investigative Site, New York, New York

Status

Active, not recruiting

Address

Novartis Investigative Site

New York, New York, 10029

Novartis Investigative Site, Greenville, North Carolina

Status

Active, not recruiting

Address

Novartis Investigative Site

Greenville, North Carolina, 27858

Novartis Investigative Site, Cincinnati, Ohio

Status

Withdrawn

Address

Novartis Investigative Site

Cincinnati, Ohio, 45267

Novartis Investigative Site, Philadelphia, Pennsylvania

Status

Withdrawn

Address

Novartis Investigative Site

Philadelphia, Pennsylvania, 19107

Novartis Investigative Site, Pittsburgh, Pennsylvania

Status

Completed

Address

Novartis Investigative Site

Pittsburgh, Pennsylvania, 15213

International Sites

Novartis Investigative Site, Brno Bohunice, Czechia

Status

Active, not recruiting

Address

Novartis Investigative Site

Brno Bohunice, , 625 00

Novartis Investigative Site, Olomouc, Czechia

Status

Completed

Address

Novartis Investigative Site

Olomouc, , 779 00

Novartis Investigative Site, Aarhus N, Denmark

Status

Active, not recruiting

Address

Novartis Investigative Site

Aarhus N, , 8200

Novartis Investigative Site, Hellerup, Denmark

Status

Active, not recruiting

Address

Novartis Investigative Site

Hellerup, , 2900

Novartis Investigative Site, Odense C, Denmark

Status

Active, not recruiting

Address

Novartis Investigative Site

Odense C, , DK 5000

Novartis Investigative Site, Heidelberg, Baden-Württemberg, Germany

Status

Active, not recruiting

Address

Novartis Investigative Site

Heidelberg, Baden-Württemberg, 69126

Novartis Investigative Site, Berlin, Germany

Status

Withdrawn

Address

Novartis Investigative Site

Berlin, , 13353

Novartis Investigative Site, Essen, Germany

Status

Active, not recruiting

Address

Novartis Investigative Site

Essen, , 45147

Novartis Investigative Site, Frankfurt, Germany

Status

Completed

Address

Novartis Investigative Site

Frankfurt, , 60596

Novartis Investigative Site, Hamburg, Germany

Status

Active, not recruiting

Address

Novartis Investigative Site

Hamburg, , 20246

Novartis Investigative Site, Hannover, Germany

Status

Completed

Address

Novartis Investigative Site

Hannover, , 30625

Novartis Investigative Site, Bialystok, Poland

Status

Active, not recruiting

Address

Novartis Investigative Site

Bialystok, , 15-044

Novartis Investigative Site, Lodz, Poland

Status

Active, not recruiting

Address

Novartis Investigative Site

Lodz, , 90 153

Novartis Investigative Site, Warszawa, Poland

Status

Active, not recruiting

Address

Novartis Investigative Site

Warszawa, , 01-138

Novartis Investigative Site, Edinburgh, United Kingdom

Status

Completed

Address

Novartis Investigative Site

Edinburgh, , EH1 1BE

Novartis Investigative Site, London, United Kingdom

Status

Active, not recruiting

Address

Novartis Investigative Site

London, , SW3 6PH