Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04064242 |
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Recruitment Status :
Completed
First Posted : August 21, 2019
Last Update Posted : February 21, 2024
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 62 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 |
| Actual Primary Completion Date : | September 19, 2023 |
| Actual Study Completion Date : | December 12, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: CMK389
CMK389
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Drug: CMK389
single i.v. dose every 4 weeks |
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Placebo Comparator: Placebo
Placebo
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Drug: Placebo
single i.v. dose every 4 weeks |
Primary Outcome Measures :
- Forced Vital Capacity [ Time Frame: Baseline to Week 16 ]Change in forced vital capacity, % of predicted, between CMK389 and placebo.
Secondary Outcome Measures :
- 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.
- [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.
- Pulmonary physiology [ Time Frame: Baseline to Week 16 ]Change in forced expiratory volume in one second and diffusion capacity for carbon monoxide.
- Steroid use (mg days) [ Time Frame: Baseline to Week 16 ]Difference in steroid usage for each arm of the study.
- Exercise capacity [ Time Frame: Baseline to Week 16 ]Change in 6-minute walk distance.
- Pharmacokinetics of CMK389 maximum concentration (Cmax) [ Time Frame: Day 1 through Week 28 ]The observed maximum plasma concentration (Cmax/end of infusion) [mass / volume].
- 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
- 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
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
Locations
| United States, Alabama | |
| Univ of Alabama at Birmingham . | |
| Birmingham, Alabama, United States, 35294-3300 | |
| United States, Florida | |
| Univ of Florida College of Medicine x | |
| Gainesville, Florida, United States, 32610 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7330 | |
| United States, Maryland | |
| John Hopkins Asthma and Allergy Center | |
| Baltimore, Maryland, United States, 21224 | |
| United States, New York | |
| Icahn School Of Med At Mount Sinai . | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| East Carolina University . | |
| Greenville, North Carolina, United States, 27858 | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Czechia | |
| Novartis Investigative Site | |
| Brno Bohunice, Czechia, 625 00 | |
| Novartis Investigative Site | |
| Olomouc, Czechia, 779 00 | |
| Denmark | |
| Novartis Investigative Site | |
| Aarhus N, Denmark, 8200 | |
| Novartis Investigative Site | |
| Hellerup, Denmark, 2900 | |
| Novartis Investigative Site | |
| Odense C, Denmark, DK 5000 | |
| Germany | |
| Novartis Investigative Site | |
| Heidelberg, Baden-Württemberg, Germany, 69126 | |
| Novartis Investigative Site | |
| Essen, Germany, 45147 | |
| Novartis Investigative Site | |
| Frankfurt, Germany, 60596 | |
| Novartis Investigative Site | |
| Hamburg, Germany, 20246 | |
| Novartis Investigative Site | |
| Hannover, Germany, 30625 | |
| Poland | |
| Novartis Investigative Site | |
| Bialystok, Poland, 15-044 | |
| Novartis Investigative Site | |
| Lodz, Poland, 90 153 | |
| Novartis Investigative Site | |
| Warszawa, Poland, 01-138 | |
| United Kingdom | |
| Novartis Investigative Site | |
| Edinburgh, United Kingdom, EH1 1BE | |
| Novartis Investigative Site | |
| London, United Kingdom, SW3 6PH | |
Sponsors and Collaborators
Novartis Pharmaceuticals
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04064242 |
| Other Study ID Numbers: |
CCMK389X2201 |
| First Posted: | August 21, 2019 Key Record Dates |
| Last Update Posted: | February 21, 2024 |
| Last Verified: | February 2024 |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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chronic pulmonary sarcoidosis |
Additional relevant MeSH terms:
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Sarcoidosis, Pulmonary Sarcoidosis Lymphoproliferative Disorders Lymphatic Diseases Hypersensitivity, Delayed |
Hypersensitivity Immune System Diseases Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases |