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

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2016-001255-49-DE
• Date of registration: 11/07/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Study of efficacy, safety and tolerability of ACZ885 (Canakinumab) in patients with pulmonary sarcoidosis
• Scientific 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
• Date of first enrolment: 15/08/2016
• Target sample size: 38
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001255-49
• 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany, 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
Clinically active disease demonstrated either by a biopsy (any organ) or by bronchoalveolar lavage, patients must also
have all of the following criteria:
- MMRC dyspnea scale =1
- Threshold FVC 50 - 90% of predicted
- Evidence of parenchymal lung involvement by HRCT at screening or by historical radiological evidence
- Male and female subjects ages 18 to 80 years of age weighting at least 50 kg
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 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion criteria:
- 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) - Thrombocytopenia CTCAE v4.03 Grade 1: Platelets - Any active or recurrent bacterial, fungal (with exception of onychomycosis) or viral infection
- Presence of human immunodeficiency virus (HIV)infection, active hepatitis B or hepatitis C infections
- 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: 20.0 Level: PT Classification code 10037430 Term: Pulmonary sarcoidosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

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

Primary Outcome(s)

Secondary Objective: - To determine the effect of ACZ885 on decreasing the maximum standardized uptake value (SUVmax) [F-18]FDGPET in nodules (nodular uptake regions)
- To determine the effect of ACZ885 versus placebo on other
parameters of pulmonary function testing (i.e., absolute
FVC, FEV1, FEV1/FVC, FEV3,FEF25-75, FEV3/FVC, 1- (FEV3/FVC), TLC, RV, RV/TLC, DLco and postbronchodilator FEV1/reversibility)
- To determine the effect of ACZ885 versus placebo on HRCT of patients with sarcoidosis as measured by side-by-side comparison by blinded reviewers and HRCT scoring
- To determine the effect of ACZ885 versus placebo on the 6-
minute walk test (6MWT) distance of patients with sarcoidosis
- To determine the effect of ACZ885 on additional [F-18]FDG-PET outcomes (i.e., SUVmean, SUVpeak and volume of the lesions)
- To assess the safety and tolerability of ACZ885 in patients with sarcoidosis as measured by adverse events (AEs)

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

Primary end point(s): Change from baseline in percent predicted forced vital
capacity (FVC)

Main Objective: - To compare the effect of ACZ885 versus placebo on the clinical disease activity of sarcoidosis patients as measured by the change from baseline in the percent predicted forced vital capacity (FVC)

Secondary Outcome(s)

Secondary end point(s): - Percent change from initial scan in [F-18]FDG-PET
- Lung function testing results(I i.e., absolute FVC, FEV1, FEV1/FVC, FEV3,FEF25-75, FEV3/FVC, 1- (FEV3/FVC), TLC, RV, RV/TLC, DLco and postbronchodilator FEV1/reversibility)
-HRCT results compared to HRCT initial scan measured by blinded
reviewers and HRCT scoring
- 6MWT results compared to baseline
- Percent change from initial scan in additional [F-18]FDG PET outcomes
- Adverse events in patients taking ACZ885 compared to placebo

Timepoint(s) of evaluation of this end point: 12 or/and 24 weeks

Secondary ID(s)

CACZ885X2205

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date:
Contact: