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Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Patients With Pulmonary Sarcoidosis

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ClinicalTrials.gov Identifier: NCT02888080
Recruitment Status : Active, not recruiting
First Posted : September 2, 2016
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is to assess if ACZ885 will improve lung function in association with reduction of tissue inflammation in patients with chronic sarcoidosis.

Condition or disease Intervention/treatment Phase
Pulmonary Sarcoidosis Drug: ACZ885 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple-dose, Subject and Investigator Blinded, Placebo-controlled, Parallel Design Study to Assess the Efficacy, Safety and Tolerability of ACZ885(Canakinumab) in Patients With Pulmonary Sarcoidosis
Actual Study Start Date : December 19, 2016
Estimated Primary Completion Date : March 4, 2019
Estimated Study Completion Date : March 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis
Drug Information available for: Canakinumab

Arm Intervention/treatment
Experimental: ACZ885
ACZ885 (300 mg/2 mL) will be administered subcutaneously to assigned study subjects once monthly for 6 months.
Drug: ACZ885
ACZ885 will be administered subcutaneously to assigned study subjects once monthly for 6 months.
Other Name: Canakinumab

Placebo Comparator: Placebo
Placebo (0 mg/2 mL) will be administered subcutaneously to assigned study subjects once monthly for 6 months.
Drug: Placebo
Placebo will be administered subcutaneously to assigned study subjects once monthly for 6 months.




Primary Outcome Measures :
  1. Change between baseline and week 24 in pulmonary function as measured by spirometry [ Time Frame: Baseline and Week 24 ]
    To compare the effect of ACZ885 versus placebo in the change between baseline and week 24 in pulmonary function as measured by spirometry.


Secondary Outcome Measures :
  1. Change between baseline and week 12 in pulmonary tissue inflammation as measured by [F-18]FDG-PET/CT [ Time Frame: Baseline and Week 12 ]
    To determine the effect of ACZ885 on the change of pulmonary tissue inflammation as measured by [F-18]FDG-PET/CT from baseline after 12 weeks of treatment compared to placebo.

  2. Change from baseline in other parameters of pulmonary function testing [ Time Frame: Baseline and Week 24 ]
    To determine the effect of ACZ885 versus placebo on other parameters of pulmonary function testing in patients with sarcoidosis at 24 weeks compared to baseline.

  3. Change from baseline in High Resolution Computed Tomography (HRCT) scoring [ Time Frame: Baseline and Week 24 ]
    To determine the effect of ACZ885 versus placebo on HRCT of patients with sarcoidosis at 24 weeks compared to initial HRCT scan as measured by side-by-side comparison by blinded reviewers and HRCT scoring.

  4. Change from baseline distance walked as assessed by the 6-minute walk test [ Time Frame: Baseline, Week 12, and Week 24 ]
    To determine the effect of ACZ885 versus placebo on the 6-minute walk test distance of patients with sarcoidosis at 12 and 24 weeks compared to baseline

  5. Change from baseline of additional [F-18]FDG-PET outcomes [ Time Frame: Baseline and Week 12 ]
    To determine the effect of ACZ885 on additional [F-18]FDG-PET outcomes after 12 weeks of treatment compared to placebo.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male and female subjects ages 18 to 80 years of age (both inclusive)
  • Pulmonary sarcoidosis disease duration of ≥1 year
  • Clinically active disease demonstrated either by a biopsy (any organ) or by bronchoalevolar lavage (lymphocytosis >15%, CD4+/CD8+ ration>3.5, CD103+/CD4+/CD4+ ratio <0.2). Patients must also have all of the following criteria:

    1. MMRC dyspnea scale ≥1
    2. Threshold FVC 50 - 90% of predicted
    3. Evidence of parenchymal lung involvement by HRCT at screening or by historical radiological evidence (e.g. CT, MRI or x-ray)

Key Exclusion Criteria:

  • Treated pulmonary hypertension
  • Previous exposure to concomitant treatment according to the following criteria:

    1. Prednisone >15 mg/day or changes in prednisone dose in the 8 weeks prior to screening
    2. More than one immune-modulator (i.e., methotrexate, azathioprine, leflunomide, hydroxychloroquine) or changes in their dosing levels within 12 weeks of randomization.
    3. Mycophenolate use within 12 weeks of randomization
  • Prior treatment with any biologic drug targeting the immune system within 180 days of randomization or history of any previous use of rituximab
  • History of bleeding disorder
  • Forced vital capacity (FVC) <50% of predicted
  • Extra-pulmonary sarcoidosis as primary treatment indication (e.g., involving brain, heart, eye and renal disease with significant hypercalcemia)
  • Any conditions or significant medical problems which in the opinion of the investigator immune-compromise the patient and/or places the patient at unacceptable risk for immunomodulatory therapy, such as:

    1. Absolute neutrophil count (ANC) <LLN (1,500/μl)
    2. Thrombocytopenia CTCAE v4.03 Grade 1: Platelets <LLN (75.0 x 109/L)
    3. Any active or recurrent bacterial, fungal (with exception of onychomycosis) or viral infection
    4. Presence of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C infections based on screening lab results
    5. Presence of active or latent tuberculosis (TB). If historical Tb result is available, Tb status needs to be confirmed pre-randomization as determined by screening laboratory measurements.
    6. Clinical evidence or history of multiple sclerosis or other demyelinating diseases, or Felty's syndrome
  • Live vaccinations within 3 months prior to the start of the trial
  • Current severe progressive or uncontrolled disease which in the judgment of the clinical investigator renders the patient unsuitable for the trial
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception defined in the protocol for the study.

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): NCT02888080


Locations
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United States, Alabama
Novartis Investigative Site
Birmingham, Alabama, United States, 35294-0006
United States, New York
Novartis Investigative Site
Albany, New York, United States, 12208
United States, Ohio
Novartis Investigative Site
Cleveland, Ohio, United States, 44195
Germany
Novartis Investigative Site
Essen, Germany, 45147
Novartis Investigative Site
Frankfurt, Germany, 60596
Novartis Investigative Site
Hannover, Germany, 30625
Netherlands
Novartis Investigative Site
Nieuwegein, Netherlands, 3435 CM
Novartis Investigative Site
Rotterdam, Netherlands, 3015 CE
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02888080     History of Changes
Other Study ID Numbers: CACZ885X2205
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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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 ):
pulmonary sarcoidosis
sarcoidosis
canakinumab
autoimmune diseases
granulomas
inflammation
lung function testing
immunosuppressive agents
interleukin
interleukin-1Beta
[F-18]FDG-PET/CT
respiratory
pulmonary
steroids
corticosteroids
lung diseases

Additional relevant MeSH terms:
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Sarcoidosis
Sarcoidosis, Pulmonary
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs