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

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 - CACZ885X2205

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46232

Enrollment

Registered

2017-09-21

Start date

2016-12-22

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonay sarcoidosis

Interventions

ACZ885 or placebo

ACZ885

efficacy

pulmonary sarcoidosis

safety

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Disease duration of *1 year - Clinically active disease demonstated 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

Exclusion criteria

Exclusion criteria: - Forced vital capacity (FVC)

Design outcomes

Primary

Measure	Time frame
FVC (forced vital capacity)	—

Secondary

Measure	Time frame
SUVmax (maximum standardized uptake value) in nodules Lung function tests HRCT 6MWT (6-minute walk test) distance PET scan Safety and tolerability of ACZ885	—

Countries

Germany, Netherlands, United States of America

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)