Trial · NCT02888080

Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Patients With Pulmonary Sarcoidosis

NCT02888080, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2020-03-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Patients With Pulmonary Sarcoidosis. Trials, record NCT02888080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02888080

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Patients With Pulmonary Sarcoidosis
NCT number: NCT02888080
Status: Completed
Phases: Phase 2
Enrollment: 40 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Pulmonary Sarcoidosis
Interventions: ACZ885, Placebo
First posted: 2016-09-02
Last updated: 2021-10-04
Results first posted: 2020-03-16

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change Between Baseline and Week 24 in Pulmonary Function as Measured by Spirometry	Baseline, Week 24	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).
Secondary	Change Between Baseline and Week 12 in Pulmonary Tissue Inflammation (Lung Parenchyma) as Measured by SUVmax[F-18]FDG-PET/CT	Baseline, Week 12	To determine the effect of ACZ885 on the change of pulmonary tissue inflammation as measured by SUVmax\[F-18\]FDG-PET/CT from baseline after 12 weeks of treatment compared to placebo.
Secondary	Change Between Baseline and Week 12 in Nodular Uptake Regions as Measured by SUVmax[F-18]FDG-PET/CT	Baseline, Week 12	To determine the effect of ACZ885 on decreasing the maximum standardized uptake value (SUVmax) \[F-18\]FDG-PET in nodules (nodular uptake regions) after 12 weeks of treatment, compared to placebo.
Secondary	Change Between Baseline and Week 12 in in the Extrathoracic Region as Measured by SUVmax[F-18]FDG-PET/CT	Baseline, Week 12	To determine the effect of ACZ885 on decreasing the maximum standardized uptake value (SUVmax) \[F-18\]FDG-PET in in the extrathoracic Region after 12 weeks of treatment, compared to placebo.
Secondary	Change From Baseline in Other Parameters of Pulmonary Function Testing (FEV 1, 3, 6 Seconds and Predicted)	Baseline, week 24	To determine the effect of ACZ885 versus placebo on other parameters of pulmonary function testing in patients with sarcoidosis at 24 weeks compared to baseline. Forced Expiratory Volume (FEV) in 1, 3, 6 seconds, predicted and forced expiratory flow 25-75%. Results expressed in change from baseline
Secondary	Change From Baseline in High Resolution Computed Tomography (HRCT) Scoring	Baseline, Week 24	To determine the effect of ACZ885 versus placebo on HRCT of patients with sarcoidosis at 24 weeks compared to initial HRCT scan as measured by side-by-side comparison by blinded reviewers and HRCT scoring. HRCT score : sum of total parameters scores, each measured in different lung zones (right upper lobe; left upper lobe; right middle lobe; right lower lobe; left lower lobe). The extent of the disease is assessed for each zone to the nearest 10% of parenchymal surface: 0 (no disease) to 10 (91-100% disease).
Secondary	Change From Baseline Distance Walked as Assessed by the 6-minute Walk Test	Baseline, Week 12, and Week 24	To determine the effect of ACZ885 versus placebo on the 6-minute walk test distance of patients with sarcoidosis at 12 and 24 weeks compared to baseline
Secondary	Change From Baseline of Additional [F-18]FDG-PET Outcomes	Baseline, Week 12	To determine the effect of ACZ885 on additional \[F-18\]FDG-PET outcomes after 12 weeks of treatment compared to placebo. SUVmean: Mean standard uptake value for activity in the focal region volume SUVpeak: Mean standardized uptake value of a sphere (a diamater of approximately 1.2cm - to produce a 1-cm3-volume spherical Region of Interest (ROI) that has the highest average SUV with the lesion volume
Secondary	Change From Baseline in Other Parameters of Pulmonary Function Testing : Diffusion Capacity of Lung for CO	Baseline, week 24	To determine the effect of ACZ885 versus placebo on other parameters of pulmonary function testing in patients with sarcoidosis at 24 weeks compared to baseline.
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)	Baseline, week 24	To determine the effect of ACZ885 versus placebo on other parameters of pulmonary function testing in patients with sarcoidosis at 24 weeks compared to baseline. Percent Predicted DLco (Diffusion Capacity of Lung for CO), FEV1/FVC, FEV3/FVC (forced expiratory volume in 1 or 3 seconds /forced vital capacity), percent Predicted FEF25-75, RV/TLC

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change Between Baseline and Week 24 in Pulmonary Function as Measured by Spirometry	Baseline, Week 24	Pharmacodynamic Analysis Set, with measure	Percent Predicted Forced Vital Capacity	MEAN
SECONDARY	Change Between Baseline and Week 12 in Pulmonary Tissue Inflammation (Lung Parenchyma) as Measured by SUVmax[F-18]FDG-PET/CT	Baseline, Week 12	Pharmacodynamic Analysis Set, with measure	percentage (Mean % Change In SUVmax)	MEAN
SECONDARY	Change Between Baseline and Week 12 in Nodular Uptake Regions as Measured by SUVmax[F-18]FDG-PET/CT	Baseline, Week 12	Pharmacodynamic Analysis Set, with measure	percentage (Mean % Change In SUVmax)	MEAN
SECONDARY	Change Between Baseline and Week 12 in in the Extrathoracic Region as Measured by SUVmax[F-18]FDG-PET/CT	Baseline, Week 12	Pharmacodynamic Analysis Set, with measure	percentage (Mean % Change In SUVmax)	MEAN
SECONDARY	Change From Baseline in Other Parameters of Pulmonary Function Testing (FEV 1, 3, 6 Seconds and Predicted)	Baseline, week 24	Pharmacodynamic Analysis Set, with measure	Liter/second	MEDIAN
SECONDARY	Change From Baseline in High Resolution Computed Tomography (HRCT) Scoring	Baseline, Week 24	Pharmacodynamic Analysis Set, with measure	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline Distance Walked as Assessed by the 6-minute Walk Test	Baseline, Week 12, and Week 24	Pharmacodynamic Analysis Set, with measure	meter	MEAN
SECONDARY	Change From Baseline of Additional [F-18]FDG-PET Outcomes	Baseline, Week 12	Pharmacodynamic Analysis Set, with measure	Percentage of Change In SUVmean	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Other Parameters of Pulmonary Function Testing : Diffusion Capacity of Lung for CO	Baseline, week 24	Pharmacodynamic Analysis Set, with measure	mL/min/mmHg	MEAN
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)	Baseline, week 24	Pharmacodynamic Analysis Set, with measure	percentage	MEAN

Source ClinicalTrials.gov

Results by group54

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change Between Baseline and Week 24 in Pulmonary Function as Measured by Spirometry	ACZ885		-1.90	Standard Deviation 3.91	Percent Predicted Forced Vital Capacity
Change Between Baseline and Week 24 in Pulmonary Function as Measured by Spirometry	Placebo		0.52	Standard Deviation 3.37	Percent Predicted Forced Vital Capacity
Change Between Baseline and Week 12 in Pulmonary Tissue Inflammation (Lung Parenchyma) as Measured by SUVmax[F-18]FDG-PET/CT	ACZ885		-4.48	Standard Deviation 37.45	percentage (Mean % Change In SUVmax)
Change Between Baseline and Week 12 in Pulmonary Tissue Inflammation (Lung Parenchyma) as Measured by SUVmax[F-18]FDG-PET/CT	Placebo		4.07	Standard Deviation 26.61	percentage (Mean % Change In SUVmax)
Change Between Baseline and Week 12 in Nodular Uptake Regions as Measured by SUVmax[F-18]FDG-PET/CT	ACZ885		-7.70	Standard Deviation 35.77	percentage (Mean % Change In SUVmax)
Change Between Baseline and Week 12 in Nodular Uptake Regions as Measured by SUVmax[F-18]FDG-PET/CT	Placebo		1.03	Standard Deviation 41.10	percentage (Mean % Change In SUVmax)
Change Between Baseline and Week 12 in in the Extrathoracic Region as Measured by SUVmax[F-18]FDG-PET/CT	ACZ885		-21.4	Standard Deviation 13.15	percentage (Mean % Change In SUVmax)
Change Between Baseline and Week 12 in in the Extrathoracic Region as Measured by SUVmax[F-18]FDG-PET/CT	Placebo		1.76	Standard Deviation 39.60	percentage (Mean % Change In SUVmax)
Change From Baseline in Other Parameters of Pulmonary Function Testing (FEV 1, 3, 6 Seconds and Predicted)	ACZ885	FEV in 1 Second	-0.06	90% Confidence Interval -0.12 to 0.01	Liter/second
Change From Baseline in Other Parameters of Pulmonary Function Testing (FEV 1, 3, 6 Seconds and Predicted)	Placebo	FEV in 1 Second	0.05	90% Confidence Interval -0.202 to 0.12	Liter/second

1 to 10 of 54Source ClinicalTrials.gov

See all 54 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	ACZ885	20
Overall Study	STARTED	Placebo	20
Overall Study	COMPLETED	ACZ885	18
Overall Study	COMPLETED	Placebo	15
Overall Study	NOT COMPLETED	ACZ885	2
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events48

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Ear pain	Ear and labyrinth disorders	ACZ885 300 mg	2	20
other	Ear pain	Ear and labyrinth disorders	Placebo	0	20
other	Diarrhoea	Gastrointestinal disorders	ACZ885 300 mg	2	20
other	Diarrhoea	Gastrointestinal disorders	Placebo	2	20
other	Nausea	Gastrointestinal disorders	ACZ885 300 mg	2	20
other	Nausea	Gastrointestinal disorders	Placebo	1	20
other	Vomiting	Gastrointestinal disorders	ACZ885 300 mg	2	20
other	Vomiting	Gastrointestinal disorders	Placebo	1	20
other	Fatigue	General disorders	ACZ885 300 mg	6	20
other	Fatigue	General disorders	Placebo	5	20

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ACZ885 300 mg	0	20
Total, all-cause mortality	Placebo	0	20
Total, other adverse events	ACZ885 300 mg	15	20
Total, other adverse events	Placebo	14	20
Total, serious adverse events	ACZ885 300 mg	3	20
Total, serious adverse events	Placebo	4	20

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
ACZ885 300 mg vs Placebo: deaths from any cause	Trial comparisons
ACZ885 300 mg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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