Phase 2
N=40
Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Patients With Pulmonary Sarcoidosis
Pulmonary Sarcoidosis
Bottom Line
View on ClinicalTrials.gov: NCT02888080 ↗Enrolled (actual)
40
Serious AEs
17.5%
Results posted
Mar 2020
Primary outcome: Primary: Change Between Baseline and Week 24 in Pulmonary Function as Measured by Spirometry — -1.90; 0.52 Percent Predicted Forced Vital Capacity
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ACZ885 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change Between Baseline and Week 24 in Pulmonary Function as Measured by Spirometry |
-1.90; 0.52 | — |
| SECONDARY Change Between Baseline and Week 12 in Pulmonary Tissue Inflammation (Lung Parenchyma) as Measured by SUVmax[F-18]FDG-PET/CT |
-4.48; 4.07 | — |
| SECONDARY Change Between Baseline and Week 12 in Nodular Uptake Regions as Measured by SUVmax[F-18]FDG-PET/CT |
-7.70; 1.03 | — |
| SECONDARY Change Between Baseline and Week 12 in in the Extrathoracic Region as Measured by SUVmax[F-18]FDG-PET/CT |
-21.4; 1.76 | — |
| SECONDARY Change From Baseline in Other Parameters of Pulmonary Function Testing (FEV 1, 3, 6 Seconds and Predicted) |
-0.06; 0.05; -0.08; 0.04; -0.08; 0.04 | — |
| SECONDARY Change From Baseline in High Resolution Computed Tomography (HRCT) Scoring |
0.11; 0.00; 0.14; -0.26; 0.12; -0.21 | — |
| SECONDARY Change From Baseline Distance Walked as Assessed by the 6-minute Walk Test |
453.65; 502.36; 471.57; 510.39; 479.40; 511.74 | — |
| SECONDARY Change From Baseline of Additional [F-18]FDG-PET Outcomes |
-12.1; -4.77; -6.39; -3.87; -9.75; -15.2 | — |
| SECONDARY Change From Baseline in Other Parameters of Pulmonary Function Testing : Diffusion Capacity of Lung for CO |
-0.85; -1.05 | — |
| SECONDARY Change From Baseline in Other Parameters of Pulmonary Function Testing : Percent Predicted DLco, FEV1/FVC, FEV3/FVC, Percent Predicted Forced Expiratory Flow (FEF) 25-75, RV/TLC (Residual Volume /Total Lung Capacity) |
-2.68; -2.71; 0.19; 0.73; -0.05; 0.21 | — |
Summary
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.
Eligibility Criteria
Key Inclusion Criteria
- Male and female subjects ages 18 to 80 years of age (both inclusive)
- Pulmonary sarcoidosis disease duration of ≥1 year
- Clinically active disease demonstrated either by a biopsy (any organ) or by bronchoalevolar lavage (lymphocytosis >15%, CD4+/CD8+ ration>3.5, CD103+/CD4+/CD4+ ratio 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 10exp9/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). If historical Tb result is available, Tb status needs to be confirmed pre-randomization as determined by screening laboratory measurements.
- 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.
Data sourced from ClinicalTrials.gov (NCT02888080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.