NCT02888080

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2016

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 19, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

March 16, 2020

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

2.2 years

First QC Date

August 16, 2016

Results QC Date

March 2, 2020

Last Update Submit

September 30, 2021

Conditions

Pulmonary Sarcoidosis

Keywords

pulmonary sarcoidosissarcoidosiscanakinumabautoimmune diseasesgranulomasinflammationlung function testingimmunosuppressive agentsinterleukininterleukin-1Beta[F-18]FDG-PET/CTrespiratorypulmonarysteroidscorticosteroidslung diseases

Outcome Measures

Primary Outcomes (1)

  • Change Between Baseline and Week 24 in Pulmonary Function as Measured by Spirometry

    To compare the effect of ACZ885 versus placebo in the change between baseline and week 24 in pulmonary function as measured by spirometry (Predicted Forced Vital Capacity).

    Baseline, Week 24

Secondary Outcomes (9)

  • Change Between Baseline and Week 12 in Pulmonary Tissue Inflammation (Lung Parenchyma) as Measured by SUVmax[F-18]FDG-PET/CT

    Baseline, Week 12

  • Change Between Baseline and Week 12 in Nodular Uptake Regions as Measured by SUVmax[F-18]FDG-PET/CT

    Baseline, Week 12

  • Change Between Baseline and Week 12 in in the Extrathoracic Region as Measured by SUVmax[F-18]FDG-PET/CT

    Baseline, Week 12

  • Change From Baseline in Other Parameters of Pulmonary Function Testing (FEV 1, 3, 6 Seconds and Predicted)

    Baseline, week 24

  • Change From Baseline in High Resolution Computed Tomography (HRCT) Scoring

    Baseline, Week 24

  • +4 more secondary outcomes

Study Arms (2)

ACZ885

EXPERIMENTAL

ACZ885 (300 mg/2 mL) will be administered subcutaneously to assigned study subjects once monthly for 6 months.

Drug: ACZ885

Placebo

PLACEBO COMPARATOR

Placebo (0 mg/2 mL) will be administered subcutaneously to assigned study subjects once monthly for 6 months.

Drug: Placebo

Interventions

ACZ885DRUG

ACZ885 will be administered subcutaneously to assigned study subjects once monthly for 6 months.

Also known as: Canakinumab
ACZ885
PlaceboDRUG

Placebo will be administered subcutaneously to assigned study subjects once monthly for 6 months.

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \<0.2). 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 (e.g. CT, MRI or x-ray)

You may not qualify if:

  • Treated pulmonary hypertension
  • Previous exposure to concomitant treatment according to the following criteria:
  • Prednisone \>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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Novartis Investigative Site

Birmingham, Alabama, 35294-0006, United States

Location

Novartis Investigative Site

Albany, New York, 12208, United States

Location

Novartis Investigative Site

Cleveland, Ohio, 44195, United States

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Frankfurt, 60596, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Nieuwegein, 3435 CM, Netherlands

Location

Novartis Investigative Site

Rotterdam, 3015 CE, Netherlands

Location

Related Links

MeSH Terms

Conditions

Sarcoidosis, PulmonarySarcoidosisAutoimmune DiseasesGranulomaInflammationLung Diseases

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialRespiratory Tract DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
novartis.email@novartis.com
862-778-8300

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

September 2, 2016

Study Start

December 19, 2016

Primary Completion

March 4, 2019

Study Completion

March 4, 2019

Last Updated

October 4, 2021

Results First Posted

March 16, 2020

Record last verified: 2021-09

Locations

NL(2)US(3)DE(3)