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Clinical Trials/NCT04064242
NCT04064242CompletedPhase 2

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

Novartis Pharmaceuticals7 sites in 2 countries62 target enrollmentStarted: September 23, 2020Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
62
Locations
7
Primary Endpoint
Change in Percent Predicted FVC From Baseline to 16 Weeks of Treatment
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this proof of concept study was to determine whether CMK389 displays the safety and efficacy profile to support further development in chronic pulmonary sarcoidosis.

Detailed Description

This was a subject and investigator blinded, randomized, placebo-controlled, parallel-group, repeat-dose, multicenter, non-confirmatory study of CMK389 in chronic pulmonary sarcoidosis. This study investigated the safety and efficacy of 10 mg/kg CMK389 administered intravenously (i.v.) every 4 weeks for a total of 4 doses, versus placebo

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subjects must have a body mass index (BMI) at screening within the range of 18 - 46 kg/m
  • •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

Arms & Interventions

CMK389

Experimental

CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses

Intervention: CMK389 (Drug)

Placebo

Placebo Comparator

Placebo i.v. every 4 weeks for a total of 4 doses

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Change in Percent Predicted FVC From Baseline to 16 Weeks of Treatment

Time Frame: Baseline, Week 16

To assess the effect of CMK389 compared to placebo after 16 weeks of treatment on spirometry (Forced Vital Capacity). Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Percent predicted FVC is the percentage of the age, height and gender adjusted predicted value.

Secondary Outcomes

  • Number of Participants Who Had an Increase in Steroid Usage From Baseline to 16 Weeks of Treatment(Baseline, Week 16)
  • Number of Participants Who Deteriorate From Baseline to 16 Weeks of Treatment(Baseline, Week 16)
  • Percent Change in [18F]-FDG-PET/CT (SUVmax and SUVmean) From Baseline to 16 Weeks of Treatment(Baseline, Week 16)
  • The Observed Serum Concentration Following CMK389 Administration at End of Infusion(Post 1 hour: Day 1, Day 29, Day 57, Day 85)
  • Pre-dose Trough Concentration (Ctrough) of CMK389(Pre-dose: Day 1, Day 29, Day 57, Day 85)
  • Change in FEV1 From Baseline to 16 Weeks of Treatment(Baseline, Week 16)
  • Change in Diffusion Capacity of the Lung for Carbon Monoxide (DLCO) From Baseline to 16 Weeks of Treatment(Baseline, Week 16)
  • Change in 6-minute Walk Distance (6MWD) From Baseline to 16 Weeks of Treatment(Baseline, Week 16)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (7)

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