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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064242
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Sarcoidosis Drug: CMK389 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to one of two treatment arms, either CMK389 or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : April 14, 2023
Estimated Study Completion Date : July 6, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Arm Intervention/treatment
Experimental: CMK389
CMK389
Drug: CMK389
single i.v. dose every 4 weeks

Placebo Comparator: Placebo
Placebo
Drug: Placebo
single i.v. dose every 4 weeks




Primary Outcome Measures :
  1. Forced Vital Capacity [ Time Frame: Baseline to Week 16 ]
    Change in forced vital capacity, % of predicted, between CMK389 and placebo.


Secondary Outcome Measures :
  1. Composite index of pulmonary physiology and exercise capacity [ Time Frame: Baseline to Week 16 ]
    Relative reduction in forced volume capacity ≥ 10% or relative reduction in forced expiratory volume in one second ≥ 10% or relative reduction of diffusion capacity ≥ 15% or relative reduction of 6-minute walk distance ≥ 50 meters.

  2. [18F]-fluorodeoxyglucose positron emission tomography/computed tomography [ Time Frame: Baseline to Week 16 ]
    Change in imaging maximum standardized uptake value and mean standardized uptake value.

  3. Pulmonary physiology [ Time Frame: Baseline to Week 16 ]
    Change in forced expiratory volume in one second and diffusion capacity for carbon monoxide.

  4. Steroid use (mg days) [ Time Frame: Baseline to Week 16 ]
    Difference in steroid usage for each arm of the study.

  5. Exercise capacity [ Time Frame: Baseline to Week 16 ]
    Change in 6-minute walk distance.

  6. Pharmacokinetics of CMK389 maximum concentration (Cmax) [ Time Frame: Day 1 through Week 28 ]
    The observed maximum plasma concentration (Cmax/end of infusion) [mass / volume].

  7. Pharmacokinetics of CMK389 trough concentration (Ctrough) [ Time Frame: Day 1 through Week 28 ]
    The lowest concentration of drug (Ctrough) reached before the next dose is administered.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • A known diagnosis of cardiac sarcoidosis. Patients who were successfully treated in the past and are on a stable regimen for the treatment of cardiac sarcoidosis for > 6 months can enroll.
  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064242


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Alabama
Novartis Investigative Site Recruiting
Birmingham, Alabama, United States, 35294-3300
United States, Colorado
Novartis Investigative Site Recruiting
Denver, Colorado, United States, 80206
United States, Florida
Novartis Investigative Site Recruiting
Gainesville, Florida, United States, 32610
United States, Illinois
Novartis Investigative Site Recruiting
Chicago, Illinois, United States, 60611
United States, Kansas
Novartis Investigative Site Recruiting
Kansas City, Kansas, United States, 66160-7330
United States, Maryland
Novartis Investigative Site Recruiting
Baltimore, Maryland, United States, 21224
United States, New York
Novartis Investigative Site Recruiting
New York, New York, United States, 10029
United States, North Carolina
Novartis Investigative Site Recruiting
Greenville, North Carolina, United States, 27858
United States, Ohio
Novartis Investigative Site Withdrawn
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Novartis Investigative Site Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Czechia
Novartis Investigative Site Recruiting
Brno Bohunice, Czechia, 625 00
Novartis Investigative Site Recruiting
Olomouc, Czechia, 775 20
Denmark
Novartis Investigative Site Recruiting
Aarhus N, Denmark, 8200
Novartis Investigative Site Recruiting
Hellerup, Denmark, 2900
Novartis Investigative Site Recruiting
Odense C, Denmark, DK 5000
Germany
Novartis Investigative Site Recruiting
Heidelberg, Baden-Württemberg, Germany, 69126
Novartis Investigative Site Recruiting
Berlin, Germany, 13353
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Recruiting
Frankfurt, Germany, 60596
Novartis Investigative Site Recruiting
Hamburg, Germany, 20246
Novartis Investigative Site Recruiting
Hannover, Germany, 30625
Poland
Novartis Investigative Site Recruiting
Bialystok, Poland, 15-044
Novartis Investigative Site Recruiting
Lodz, Poland, 90 153
Novartis Investigative Site Recruiting
Warszawa, Poland, 01-138
United Kingdom
Novartis Investigative Site Recruiting
Edinburgh, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04064242    
Other Study ID Numbers: CCMK389X2201
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
chronic pulmonary sarcoidosis
Additional relevant MeSH terms:
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Sarcoidosis, Pulmonary
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases