Study of efficacy, safety and tolerability of ACZ885 (Canikumab) in patients with pulmonary sarcoidosis

• Conditions: Pulmonary sarcoidosis; MedDRA version: 17.1Level: PTClassification code 10037430Term: Pulmonary sarcoidosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-005333-21-NL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-08
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Disease duration of = 1 year
• Evidence of clinically active disease defined by having all of the following criteria:
• MMRC dyspnea questionnaire score = 1
• Threshold FVC = 80%
• Evidence of parenchymal disease on HRCT
• Positive [F-18]FDG-PET/CT signal (parenchymal and/or lymph node) on first 24 patients, for the remaining patients, HRCT will be used to confirm the positive parenchymal or lymph node involvement
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

•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 immunocompromises the patient and/ or places the patient at unacceptable risk for immunomodulatory therapy, such as:
•Absolute neutrophil count (ANC) •Platelets •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 result
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effect of ACZ885 versus placebo on the clinical disease activity of sarcoidosis patients ;Secondary Objective: • To evaluate the effect of ACZ885 versus placebo on inflammation in sarcoidosis patients.<br>• To assess the safety and tolerability of ACZ885 in patients with sarcoidosis as measured by adverse events (AEs).;Primary end point(s): Percentage change from baseline in forced vital capacity (FVC);Timepoint(s) of evaluation of this end point: 24 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • To determine the effect of ACZ885 versus placebo on the 6 minute walk test distance of patients with sarcoidosis <br>• To determine the effect of ACZ885 versus placebo on HRCT of patients with sarcoidosis.<br>• To determine the effect of ACZ885 versus placebo on other parameters of pulmonary function testing (i.e., FEV1, FEV1/FVC, FEV25-75, TLC, RV, RV/TLC and DLco) in patients with sarcoidosis.;Timepoint(s) of evaluation of this end point: 24 weeks