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

• Status: Completed
• Trial end date: 2019-03-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal

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)2. Thrombocytopenia CTCAE v4.03 Grade 1: Platelets

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.