Clinical Trial Details

NCT ID: NCT02888080
Date Last Changed: June 26, 2017

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Pulmonary Sarcoidosis

Research Study 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

Purpose

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.

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
18 to 80 Years
Overall Status
Recruiting
Lead Sponsor
Novartis Pharmaceuticals
Duration
19 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 80 Years

Key Inclusion Criteria:

  • Male and female subjects ages 18 to 80 years of age (both inclusive)

  • Pulmonary sarcoidosis disease duration of ≥1 year

  • Evidence of biopsy-proven, clinically active disease defined by having all of the following criteria:

  • MMRC dyspnea scale ≥1

  • Threshold FVC 50 - 80% of predicted

  • Evidence of parenchymal lung involvement by HRCT

Key Exclusion Criteria:

  • Treated pulmonary hypertension

  • Previous exposure to concomitant treatment within according to the following criteria:

  • Prednisone > 15 mg/day or changes in prednisone dose in the 8 weeks prior to screening

  • More than one immune-modulator (i.e., methotrexate, azathioprine, leflunomide, hydroxychloroquine) or changes in their dosing levels within 12 weeks of randomization.

  • 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:

  • Absolute neutrophil count (ANC) < LLN (1,500/μl)

  • Thrombocytopenia CTCAE v4.03 Grade 1: Platelets < LLN (75.0 x 109/L)

  • Any active or recurrent bacterial, fungal (with exception of onychomycosis) or viral infection

  • Presence of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C infections based on screening lab results

  • Presence of active or latent tuberculosis (TB) established during screening

  • 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.

Site Locations (7)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35294-0006 Novartis Investigative Site
United States New York Albany 12208 Novartis Investigative Site
Leahruth Saavedra, M.S.
518-262-0355
saavedl@mail.amc.edu
United States Ohio Cleveland 44195 Novartis Investigative Site
Daniel Culver, D.O.
CULVERD@ccf.org

Daniel Culver, D.O.
Principal Investigator
Germany Essen 45147 Novartis Investigative Site
Germany Hannover 30625 Novartis Investigative Site
Netherlands Nieuwegein 3435 CM Novartis Investigative Site
Netherlands Rotterdam 3015 CE Novartis Investigative Site

Contact

Novartis Pharmaceuticals
1-888-669-6682

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