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

• Register: EUCTR
• Last refreshed on: 14 September 2015
• Main ID: EUCTR2013-005333-21-NL
• Date of registration: 08/01/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Study of efficacy, safety and tolerability of ACZ885 (Canikumab) in patients with pulmonary sarcoidosis
• Scientific title: A multiple-dose, double-blind, placebo-controlled, parallel study to assess the efficacy, safety and tolerability of ACZ885 (Canikumab) in patients with pulmonary sarcoidosis
• Date of first enrolment: 30/06/2015
• Target sample size: 90
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005333-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Netherlands, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Pulmonary sarcoidosis
MedDRA version: 17.1 Level: PT Classification code 10037430 Term: Pulmonary sarcoidosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Trade Name: ILARIS
Product Name: Canakinumab
Product Code: ACZ885
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Canakinumab
CAS Number: 914613-48-2
Current Sponsor code: ACZ885
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 24 weeks

Primary end point(s): Percentage change from baseline in forced vital capacity (FVC)

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.
• To assess the safety and tolerability of ACZ885 in patients with sarcoidosis as measured by adverse events (AEs).

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 24 weeks

Secondary end point(s): • To determine the effect of ACZ885 versus placebo on the 6 minute walk test distance of patients with sarcoidosis
• To determine the effect of ACZ885 versus placebo on HRCT of patients with sarcoidosis.
• 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.

Secondary ID(s)

CACZ885X2202

Source(s) of Monetary Support

Novartis Pharma Services AG