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Keep this study
Lead
Novartis Pharmaceuticals
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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:
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.
Clareo Health | Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Patients With Pulmonary Sarcoidosis
