Pulmonary SarcoidosisPhase 2NCT02888080
Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Patients With Pulmonary Sarcoidosis
A Phase 2 study testing ACZ885 in people with Pulmonary Sarcoidosis, run by Novartis Pharmaceuticals at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Sarcoidosis
- What is being tested?
- ACZ885
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 19 Dec 2016to 4 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States3 sites
Novartis Investigative Site
Albany, New York, 12208
Novartis Investigative Site
Birmingham, Alabama, 35294-0006
Novartis Investigative Site
Cleveland, Ohio, 44195
Germany3 sites
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Hanover, 30625
Netherlands2 sites
Novartis Investigative Site
Nieuwegein, 3435 CM
Novartis Investigative Site
Rotterdam, 3015 CE
About this study
Official 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
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.
- Conditions
- Pulmonary Sarcoidosis
- Being tested
- ACZ885, Placebo
- Keywords
- pulmonary sarcoidosis, sarcoidosis, canakinumab, autoimmune diseases, granulomas, inflammation, lung function testing, immunosuppressive agents, interleukin, interleukin-1Beta, [F-18]FDG-PET/CT, respiratory, pulmonary, steroids, corticosteroids, lung diseases
- Medical subject headings
- Sarcoidosis, Pulmonary, Sarcoidosis, Autoimmune Diseases, Granuloma, Inflammation, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACZ885Drug
Also called Canakinumab
ACZ885 will be administered subcutaneously to assigned study subjects once monthly for 6 months.
PlaceboDrug
Placebo will be administered subcutaneously to assigned study subjects once monthly for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| ACZ885 | Experimental | ACZ885 (300 mg/2 mL) will be administered subcutaneously to assigned study subjects once monthly for 6 months. Receives: Drug: ACZ885 |
| Placebo | Placebo comparator | Placebo (0 mg/2 mL) will be administered subcutaneously to assigned study subjects once monthly for 6 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: Baseline, Week 12
Change Between Baseline and Week 12 in Nodular Uptake Regions as Measured by SUVmax[F-18]FDG-PET/CT
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.
Measured: Baseline, Week 12
Change Between Baseline and Week 12 in in the Extrathoracic Region as Measured by SUVmax[F-18]FDG-PET/CT
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.
Measured: Baseline, Week 12
Change From Baseline in Other Parameters of Pulmonary Function Testing (FEV 1, 3, 6 Seconds and Predicted)
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
Measured: Baseline, week 24
Change From Baseline in High Resolution Computed Tomography (HRCT) Scoring
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).
Measured: Baseline, Week 24
Change From Baseline Distance Walked as Assessed by the 6-minute Walk Test
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
Measured: Baseline, Week 12, and Week 24
Change From Baseline of Additional [F-18]FDG-PET Outcomes
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
Measured: Baseline, Week 12
Change From Baseline in Other Parameters of Pulmonary Function Testing : Diffusion Capacity of Lung for CO
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.
Measured: Baseline, week 24
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)
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
Measured: Baseline, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study start19 Dec 2016
- Primary completion4 Mar 2019
- Study completion4 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary SarcoidosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888080
- Sponsor's protocol ID
- CACZ885X2205
- Status last verified
- Sep 2021
- First submitted
- 16 Aug 2016
- Last updated
- 4 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02888080
- Acronym / sponsor ID
- CACZ885X2205
- Conditions
- Pulmonary Sarcoidosis
- Keywords
- pulmonary sarcoidosis, sarcoidosis, canakinumab, autoimmune diseases, granulomas, inflammation, lung function testing, immunosuppressive agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 4 Mar 2019 (actual)
- Study completion
- 4 Mar 2019 (actual)
- First posted
- 2 Sep 2016 (estimated)
- Results
- Posted 16 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACZ885 | Experimental | Drug: ACZ885ACZ885 (300 mg/2 mL) will be administered subcutaneously to assigned study subjects once monthly for 6 months. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (0 mg/2 mL) will be administered subcutaneously to assigned study subjects once monthly for 6 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (19 listed)
- Treated pulmonary hypertension
- Previous exposure to concomitant treatment according to the following criteria:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACZ885Also: CanakinumabACZ885 will be administered subcutaneously to assigned study subjects once monthly for 6 months. | Drug | ACZ885 |
| PlaceboPlacebo will be administered subcutaneously to assigned study subjects once monthly for 6 months. | Drug | Placebo |
Primary outcome
Change Between Baseline and Week 24 in Pulmonary Function as Measured by Spirometry
Time frame: 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).
9 secondary outcomes
Change Between Baseline and Week 12 in Pulmonary Tissue Inflammation (Lung Parenchyma) as Measured by SUVmax[F-18]FDG-PET/CT
Time frame: Baseline, Week 12
Change Between Baseline and Week 12 in Nodular Uptake Regions as Measured by SUVmax[F-18]FDG-PET/CT
Time frame: Baseline, Week 12
Change Between Baseline and Week 12 in in the Extrathoracic Region as Measured by SUVmax[F-18]FDG-PET/CT
Time frame: Baseline, Week 12
Change From Baseline in Other Parameters of Pulmonary Function Testing (FEV 1, 3, 6 Seconds and Predicted)
Time frame: Baseline, week 24
Change From Baseline in High Resolution Computed Tomography (HRCT) Scoring
Time frame: Baseline, Week 24
Change From Baseline Distance Walked as Assessed by the 6-minute Walk Test
Time frame: Baseline, Week 12, and Week 24
Change From Baseline of Additional [F-18]FDG-PET Outcomes
Time frame: Baseline, Week 12
Change From Baseline in Other Parameters of Pulmonary Function Testing : Diffusion Capacity of Lung for CO
Time frame: Baseline, week 24
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)
Time frame: Baseline, week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
Related trials for Pulmonary Sarcoidosis
RecruitingObservational study
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An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
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LAM-001 for the Treatment of Sarcoidosis Associated Pulmonary Hypertension (SAPH)
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Evaluation of the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis
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Pulmonary Sarcoidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACZ885 in people with Pulmonary Sarcoidosis, run by Novartis Pharmaceuticals at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Between Baseline and Week 24 in Pulmonary Function as Measured by Spirometry (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.