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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03920267




Registration number
NCT03920267
Ethics application status
Date submitted
27/03/2019
Date registered
18/04/2019
Date last updated
30/05/2024

Titles & IDs
Public title
Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus
Scientific title
A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus
Secondary ID [1] 0 0
2018-003471-35
Secondary ID [2] 0 0
IM011-074
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Cancer 0 0
Advanced Solid Tumors 0 0
Triple-Negative Breast Cancer (TNBC) 0 0
Non-small-cell-lung-cancer (NSCLC) 0 0
Metastatic Solid Tumors 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986165
Treatment: Drugs - CFZ533
Other interventions - Placebo
Treatment: Drugs - Sugammadex 4 mg/kg
Treatment: Drugs - Neostigmine + Glycopyrrolate
Treatment: Drugs - Neostigmine + Atropine
Treatment: Drugs - ABBV-927
Treatment: Drugs - ABBV-368
Treatment: Drugs - ABBV-181
Treatment: Drugs - Carboplatin
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - JNJ-67856633
Treatment: Drugs - RO6874281
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Bisoprolol
Treatment: Drugs - Placebo Oral Tablet

Experimental: Cohort 1/Arm D1 - CFZ533 dose 1 (from week 24)

Experimental: BMS-986165 Dose 1 -

Experimental: BMS-986165 Dose 2 -

Experimental: BMS-986165 Dose 3 -

Experimental: Cohort 2/Arm E - CFZ533 dose 1

Placebo comparator: Cohort 2/Arm F - Placebo dose (up to week 24)

Experimental: Cohort 2/Arm F1 - CFZ533 dose 2 (from week 24)

Experimental: Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors - Participants with Solid Tumors will receive various doses of ABBV-927 by intravenous (IV) infusion plus ABBV-368. This will determine the recommended phase two dose (RP2D) of ABBV-927.

Experimental: Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC - Participants with non-small-cell-lung-cancer (NSCLC) will receive ABBV-927 IV at various dose levels + ABBV-368 + ABBV-181. This will determine the recommended phase two dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181.

Experimental: Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBC - Participants with Triple Negative Breast Cancer (TNBC) will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-368 by IV.

Experimental: Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBC - Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-181 by IV.

Experimental: Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBC - Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin by IV.

Experimental: Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC - Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Nab-paclitaxel + ABBV-368 by IV.

Experimental: Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLC - Participants with NSCLC will receive ABBV-927 (at the RP2D established in Arm B) + ABBV-368 + ABBV-181 by IV.

Experimental: Part 2 (Cohort Expansion): JNJ-67856633 - Participants will receive JNJ-67856633 at the recommended Phase 2 dose (RP2D) determined in Part 1.

Experimental: Part I Safety Run in: RO6874281 + Pembrolizumab - Cohort 1.1 (CPI naive and experienced melanoma participants):

Participants will receive RO6874281 in combination with Pembrolizumab every 3 weeks (Q3W) and will be observed for 2 cycles (ie: 6 weeks) in order to confirm the safety of the proposed dose and schedule that will be used in Part II of this study.

Cohort 1.2 (CPI experienced melanoma participants only):

Participants will receive RO6874281 in combination with Pembrolizumab via an induction and maintenance schedule for RO6874281: QW three times (D1, D8, D15) followed by Q3W dosing (D22 and subsequent). Pembrolizumab is to be administered Q3W, starting on Day 1. Participants will be observed for 2 pembrolizumab cycles (ie: 6 weeks) in order to confirm the safety of the proposed dose and schedule that will be used in Part III of this study.

Experimental: Part II Expansion: RO6874281 + Pembrolizumab - Part II will start once all participants in Part I Cohort 1.1 have completed the observation period. Approximately 34 participants will receive RO6874281 in combination with Pembrolizumab every 3 weeks (Q3W) and will be observed for 2 cycles (ie: 6 weeks).

Experimental: Part III Expansion: RO6874281 + Pembrolizumab - Part III will start once all participants in Part I Cohorts 1.1 and 1.2 have completed the observation period. Approximately 80 participants will be randomised to receive RO6874281 in combination with Pembrolizumab in either a Q3W or QW/Q3W schedule.

Placebo comparator: Placebo - 1.25, 2.5 or 5mg of matched placebo daily


Treatment: Drugs: BMS-986165
Specified dose on specified days

Treatment: Drugs: CFZ533
Biological

Other interventions: Placebo
liquid placebo for injections

Treatment: Drugs: Sugammadex 4 mg/kg
For deep NMB reversal, a single IV bolus of sugammadex (4 mg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).

Treatment: Drugs: Neostigmine + Glycopyrrolate
For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 µg/kg; up to 5 mg maximum dose) as well as glycopyrrolate (10 µg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of T2 in response to TOF stimulations.

Treatment: Drugs: Neostigmine + Atropine
For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 µg/kg; up to 5 mg maximum dose) as well as atropine (20 µg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of T2 in response to TOF stimulations.

Treatment: Drugs: ABBV-927
Intravenous (IV) Infusion

Treatment: Drugs: ABBV-368
Intravenous (IV) Infusion

Treatment: Drugs: ABBV-181
Intravenous (IV) Infusion

Treatment: Drugs: Carboplatin
Intravenous (IV) Infusion

Treatment: Drugs: Nab-paclitaxel
Intravenous (IV) Infusion

Treatment: Drugs: JNJ-67856633
JNJ-67856633 capsule will be administered orally.

Treatment: Drugs: RO6874281
Part I Safety Run in:

Cohort 1.1: RO6874281 will be administered by intravenous (IV) infusion; 10 mg (Q3W) every 3 weeks and will be observed over 2 administration cycles (i.e. 6 weeks) in order to confirm the safety of the proposed dose and schedule that will be used in Part II of this study.

Cohort 1.2: RO6874281 will be administered by IV infusion via an induction and maintenance phase; 10 mg (QW) every week for 3 weeks followed by 10 mg (Q3W) every 3 weeks and will be observed over 2 administration cycles (6 weeks) to confirm safety of the proposed dose and schedule to be used in Part III of this study.

Part II Expansion: RO6874281 will be administered by IV infusion; 10 mg (Q3W) every 3 weeks (or lower dose level depending on Part I Cohort 1.1 outcome).

Part III Expansion: RO6874281 will be administered by IV infusion; 10 mg (QW) every week or 10mg (Q3W) every 3 weeks (or lower dose level depending on Part I Cohorts 1.1 and 1.2 outcomes) in either a Q3W or QW/Q3W schedule.

Treatment: Drugs: Pembrolizumab
Part I Safety Run in (Cohorts 1.1 and 1.2): Pembrolizumab will be administered by IV; 200 mg Q3W and will be observed over 2 administration cycles (i.e. 6 weeks).

Part II Expansion: Pembrolizumab will be administered by IV; 200 mg Q3W (or lower dose level depending on Part I Cohort 1.1 outcome)

Part III Expansion: Pembrolizumab will be administered by IV; 200 mg Q3W (or lower dose level depending on Part I Cohorts 1.1 and 1.2 outcomes)

Treatment: Drugs: Bisoprolol
As in arm description

Treatment: Drugs: Placebo Oral Tablet
As in arm description
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Adverse Events (AEs)
Timepoint [1] 0 0
Up to 30 days after last treatment dose (approximately 178 weeks)
Primary outcome [2] 0 0
Number of participants with Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 30 days after last treatment dose (approximately 178 weeks)
Primary outcome [3] 0 0
Number of participants with AEs leading to discontinuation
Timepoint [3] 0 0
Up to 30 days after last treatment dose (approximately 178 weeks)
Primary outcome [4] 0 0
Number of participants with abnormal change from baseline in laboratory measurements over time
Timepoint [4] 0 0
Up to 30 days after last treatment dose (approximately 178 weeks)
Primary outcome [5] 0 0
Number of participants with abnormal change from baseline in vital signs over time
Timepoint [5] 0 0
Up to 30 days after last treatment dose (approximately 178 weeks)
Primary outcome [6] 0 0
Change in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score from baseline at 24 weeks as compared to placebo
Timepoint [6] 0 0
24 weeks
Primary outcome [7] 0 0
Change in EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) score from baseline at 24 weeks as compared to placebo.
Timepoint [7] 0 0
24 weeks
Primary outcome [8] 0 0
Part A. Area Under the Plasma Concentration Time Curve (AUC) for Sugammadex
Timepoint [8] 0 0
Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Primary outcome [9] 0 0
Part A. Plasma Clearance (CL) of Sugammadex
Timepoint [9] 0 0
Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Primary outcome [10] 0 0
Part A. Apparent Volume of Distribution (Vz) for Sugammadex
Timepoint [10] 0 0
Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Primary outcome [11] 0 0
Part A. Apparent Volume of Distribution at Steady State (Vss) for Sugammadex
Timepoint [11] 0 0
Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Primary outcome [12] 0 0
Part A. Maximum Plasma Concentration (Cmax) of Sugammadex
Timepoint [12] 0 0
Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Primary outcome [13] 0 0
Part A. Half-Life (t1/2) of Sugammadex in Plasma
Timepoint [13] 0 0
Baseline and 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Primary outcome [14] 0 0
Part B. Time to Neuromuscular Recovery
Timepoint [14] 0 0
Within Day 1
Primary outcome [15] 0 0
Parts A and B. Adverse Events (AEs)
Timepoint [15] 0 0
Up to 7 days
Primary outcome [16] 0 0
Dose Expansion: Objective Response Rate (ORR)
Timepoint [16] 0 0
Up to approximately 2 years following the first dose of study drug
Primary outcome [17] 0 0
Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368
Timepoint [17] 0 0
Up to approximately 6 months
Primary outcome [18] 0 0
Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181
Timepoint [18] 0 0
Up to approximately 6 months
Primary outcome [19] 0 0
Part 1: Dose-Limiting Toxicity (DLT)
Timepoint [19] 0 0
Approximately 21 days
Primary outcome [20] 0 0
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Timepoint [20] 0 0
Up to 4 years and 11 months
Primary outcome [21] 0 0
Percentage of participants with adverse events
Timepoint [21] 0 0
Baseline to end of study (approximately 24 months)
Primary outcome [22] 0 0
All-cause mortality
Timepoint [22] 0 0
Baseline to 24 months
Primary outcome [23] 0 0
Hospitalisation for COPD exacerbation
Timepoint [23] 0 0
Baseline to 24 months
Primary outcome [24] 0 0
Hospitalisation for primary cardiac cause (ischaemia, arrhythmia, heart failure or ischaemic stroke)
Timepoint [24] 0 0
Baseline to 24 months
Primary outcome [25] 0 0
Moderate COPD exacerbation - not hospitalised by treated with oral corticosteroids/antibiotics or both
Timepoint [25] 0 0
Baseline to 24 months
Primary outcome [26] 0 0
Cardiac Hospitalisation for cardiac cause other than ischemia, arrythmia or heart failure
Timepoint [26] 0 0
Baseline to 24 months
Primary outcome [27] 0 0
Respiratory hospitalisation for a respiratory cause other than COPD exacerbation
Timepoint [27] 0 0
Baseline to 24 months
Primary outcome [28] 0 0
Decrease in FEV1 or greatest FEV1% drop - largest decrease in FEV1 from post-bronchodiliator spirometry at baseline
Timepoint [28] 0 0
Baseline to 24 months
Primary outcome [29] 0 0
Mild COPD exacerbation - treated with increased inhalers/inhaler technique/addition of theophylline
Timepoint [29] 0 0
Baseline to 24 months
Primary outcome [30] 0 0
Higher SGRQ score (clinically important change >= 4)
Timepoint [30] 0 0
Baseline to 12 and 24 months
Primary outcome [31] 0 0
Higher CAT score (clinically important change >= 2)
Timepoint [31] 0 0
Baseline to 12 and 24 months
Secondary outcome [1] 0 0
Change from baseline in ESSPRI at Week 24
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Change from baseline in score of Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire at Week 24
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Change from baseline in Physician Global Assessment (PhGA) at Week 24
Timepoint [3] 0 0
24 weeks
Secondary outcome [4] 0 0
Change from baseline in ESSDAI at Week 24
Timepoint [4] 0 0
24 weeks
Secondary outcome [5] 0 0
Proportion of subjects with at least 12 points improvement measured by score of Impact of Dry Eye on Everyday Life (IDEEL) questionnaire symptom bother module at Week 24.
Timepoint [5] 0 0
24 weeks
Secondary outcome [6] 0 0
Incidence of adverse events (AEs), serious adverse events (SAEs) from baseline to Week 24 and from week 24 to the end of study
Timepoint [6] 0 0
60 weeks
Secondary outcome [7] 0 0
Serum Free Light Chain (FLC) levels at analysis visit up to end of study
Timepoint [7] 0 0
60 weeks
Secondary outcome [8] 0 0
Immunoglobulin IgG and IgM levels at analysis visits up to end of study
Timepoint [8] 0 0
60 weeks
Secondary outcome [9] 0 0
Percent change from baseline in plasma CXCL-13 levels at analysis visits up to end of study
Timepoint [9] 0 0
60 weeks
Secondary outcome [10] 0 0
Part B. Time to Extubation
Timepoint [10] 0 0
Within Day 1
Secondary outcome [11] 0 0
Dose-Expansion Phase: Progression-free Survival (PFS)
Timepoint [11] 0 0
Up to approximately 2 years since the first dose of study drug
Secondary outcome [12] 0 0
Dose-Expansion Phase: Duration of Response (DOR)
Timepoint [12] 0 0
Up to approximately 2 years since the first dose of study drug
Secondary outcome [13] 0 0
Maximum Serum Concentration (Cmax)
Timepoint [13] 0 0
Up to approximately 12 weeks after participant's initial dose of study drug
Secondary outcome [14] 0 0
Time to Maximum Observed Serum Concentration (Tmax)
Timepoint [14] 0 0
Up to approximately 12 weeks after participant's initial dose of study drug
Secondary outcome [15] 0 0
Area Under the Serum Concentration Versus Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCt)
Timepoint [15] 0 0
Up to approximately 12 weeks after participant's initial dose of study drug
Secondary outcome [16] 0 0
Terminal Phase Elimination Half-life (t1/2)
Timepoint [16] 0 0
Up to approximately 4 weeks after participant's initial dose of study drug
Secondary outcome [17] 0 0
JNJ-67856633 Plasma Concentrations
Timepoint [17] 0 0
Up to 4 years and 11 months
Secondary outcome [18] 0 0
Part 1 and Part 2: Overall Response Rate (ORR)
Timepoint [18] 0 0
Up to 4 years and 11 months
Secondary outcome [19] 0 0
Part 1 and Part 2: Complete Response Rate
Timepoint [19] 0 0
Up to 4 years and 11 months
Secondary outcome [20] 0 0
Part 1 and Part 2: Time to Response (TTR)
Timepoint [20] 0 0
Up to 4 years and 11 months
Secondary outcome [21] 0 0
Part 1 and Part 2: Duration of Response (DoR)
Timepoint [21] 0 0
Up to 4 years and 11 months
Secondary outcome [22] 0 0
Objective Response Rate (ORR)
Timepoint [22] 0 0
Time from first occurrence of a documented objective response until the time of documented disease progression or death from any cause during treatment (whichever occurs first) until the end of study (approximately 24 months)
Secondary outcome [23] 0 0
Complete Response Rate (CRR)
Timepoint [23] 0 0
Baseline to end of study (approximately 24 months)
Secondary outcome [24] 0 0
Disease Control Rate (DCR)
Timepoint [24] 0 0
Baseline to end of study (approximately 24 months)
Secondary outcome [25] 0 0
Duration of Response
Timepoint [25] 0 0
Time from first occurrence of a documented objective response until the time of documented disease progression or death from any cause during treatment (whichever occurs first) until the end of study (approximately 24 months)
Secondary outcome [26] 0 0
Progression Free Survival (PFS)
Timepoint [26] 0 0
Time from study treatment initiation to the first occurrence of documented disease progression (based on Investigator's assessment) or death from any cause during treatment (whichever occurs first) until the end of study (approximately 24 months)
Secondary outcome [27] 0 0
Baseline PD-L1
Timepoint [27] 0 0
Baseline to end of study (approximately 24 months)
Secondary outcome [28] 0 0
Fibroblast Activation Protein-a (FAP)
Timepoint [28] 0 0
Baseline to end of study (approximately 24 months)
Secondary outcome [29] 0 0
Change from baseline in density (cell/mm2) of immune cells including CD8+, FOXP3, and PD-L1
Timepoint [29] 0 0
Baseline to end of study (approximately 24 months)
Secondary outcome [30] 0 0
Time to first moderate-severe COPD Exacerbation
Timepoint [30] 0 0
Baseline to 24 months
Secondary outcome [31] 0 0
Severe (hospital admission) COPD exacerbation rate (annualised)
Timepoint [31] 0 0
Baseline to 24 months
Secondary outcome [32] 0 0
Number of events of composite (annualised) cardio-respiratory hospital admissions and MACE
Timepoint [32] 0 0
Baseline to 24 months
Secondary outcome [33] 0 0
Quality of life assessed by St George's Respiratory Questionnaire (SGRQ)
Timepoint [33] 0 0
Baseline to 24 months
Secondary outcome [34] 0 0
EuroQoL Group 5-5 Dimension self-report questionnaire (EQ-5D-5L) to assess health state utilities
Timepoint [34] 0 0
Baseline to 24 months
Secondary outcome [35] 0 0
Healthcare utilisation costs and Quality Adjusted Life Years (QALYs) evaluation of the treatment intervention
Timepoint [35] 0 0
Baseline to 24 months
Secondary outcome [36] 0 0
Health status assessed by COPD Assessment Test (CAT)
Timepoint [36] 0 0
Baseline to 24 months
Secondary outcome [37] 0 0
Clinic spirometry: post-bronchodilator FEV1 (Forced Expiratory Volume) (L)
Timepoint [37] 0 0
Baseline to 24 months
Secondary outcome [38] 0 0
Clinic spirometry: % predicted post-bronchodilator
Timepoint [38] 0 0
Baseline to 24 months
Secondary outcome [39] 0 0
Hospital admissions for all respiratory causes
Timepoint [39] 0 0
Baseline to 24 months
Secondary outcome [40] 0 0
Hospital admissions for all cardiac causes
Timepoint [40] 0 0
Baseline to 24 months
Secondary outcome [41] 0 0
Total Number of cardiac events: MACE plus acute arrhythmia, Non-ST-elevation myocardial infarction (NSTEMI), urgent revascularisation (stent/angioplasty/Coronary artery bypass grafting [CABGs]) and clinically diagnosed heart failure episodes.
Timepoint [41] 0 0
Baseline to 24 months
Secondary outcome [42] 0 0
Time to a composite outcome (includes any) of: all-case mortality; hospitalisation for COPD exacerbation, hospitalisation for primary cardiac cause (arrytmmia, ischaemia or heart failure) or MACE
Timepoint [42] 0 0
Baseline to 24 months
Secondary outcome [43] 0 0
COPD exacerbation rate (annualised)
Timepoint [43] 0 0
Baseline to 24 months

Eligibility
Key inclusion criteria
* Completion of SLE Study (NCT03252587) through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product [IP] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason
* Evidence of active tuberculosis (TB)

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
Accrual to date
Final
261
Recruitment in Australia
Recruitment state(s)
WA,QLD,NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Nedlands
Recruitment hospital [2] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [3] 0 0
Perth Children's Hospital - Perth
Recruitment hospital [4] 0 0
Children's Hospital at Westmead - Sydney
Recruitment hospital [5] 0 0
The Children s Hospital at Westmead ( Site 3805) - Westmead
Recruitment hospital [6] 0 0
Queensland Children s Hospital ( Site 3806) - South Brisbane
Recruitment hospital [7] 0 0
Royal Childrens Hospital Melbourne ( Site 3801) - Parkville
Recruitment hospital [8] 0 0
Icon Cancer Centre /ID# 224084 - South Brisbane
Recruitment hospital [9] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [10] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [11] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment hospital [12] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [13] 0 0
Melanoma Institute Australia - North Sydney
Recruitment hospital [14] 0 0
Peter Maccallum Cancer Institute; Clinical Trial Unit - Melbourne
Recruitment hospital [15] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [16] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [17] 0 0
John Hunter Hospital & Hunter Medical Research Institute - Newcastle
Recruitment hospital [18] 0 0
Concord Repatriation General Hospital - Sydney
Recruitment hospital [19] 0 0
Westmead Hospital - Sydney
Recruitment hospital [20] 0 0
Prince Charles Hospital - Brisbane
Recruitment hospital [21] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [22] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [23] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [24] 0 0
TrialsWest Pty Ltd - Perth
Recruitment hospital [25] 0 0
Institute for Respiratory Health - Perth
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment postcode(s) [2] 0 0
- South Brisbane
Recruitment postcode(s) [3] 0 0
6840 - Perth
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3000 - Melbourne
Recruitment postcode(s) [10] 0 0
2031 - Randwick
Recruitment postcode(s) [11] 0 0
2060 - North Sydney
Recruitment postcode(s) [12] 0 0
2560 - Campbelltown
Recruitment postcode(s) [13] 0 0
2170 - Liverpool
Recruitment postcode(s) [14] 0 0
2305 - Newcastle
Recruitment postcode(s) [15] 0 0
2139 - Sydney
Recruitment postcode(s) [16] 0 0
2145 - Sydney
Recruitment postcode(s) [17] 0 0
4032 - Brisbane
Recruitment postcode(s) [18] 0 0
4102 - Brisbane
Recruitment postcode(s) [19] 0 0
4215 - Southport
Recruitment postcode(s) [20] 0 0
6150 - Murdoch
Recruitment postcode(s) [21] 0 0
6000 - Perth
Recruitment postcode(s) [22] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
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United States of America
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United States of America
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United States of America
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United States of America
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United States of America
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Spain
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Spain
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Spain
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Taichung
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Taiwan
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United States of America
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United States of America
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Los Rios
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Colombia
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France
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Brest
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France
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France
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Lille
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France
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Paris
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France
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Germany
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Germany
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Dresden
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Germany
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Germany
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Greece
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Athens
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Fejer
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Hungary
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Israel
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Haifa
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Israel
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Kfar Saba
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Israel
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Ramat Gan
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Italy
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MI
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Italy
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PI
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Italy
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UD
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Japan
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Aichi
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Japan
State/province [112] 0 0
Nagasaki
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Japan
State/province [113] 0 0
Okayama
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Korea, Republic of
State/province [114] 0 0
Seocho Gu
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Netherlands
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Groningen
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Netherlands
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Rotterdam
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Portugal
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Almada
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Portugal
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Lisboa
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Portugal
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Ponte de Lima
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Romania
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Cluj Napoca
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Russian Federation
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Russian Federation
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Moscow
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Russian Federation
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Russian Federation
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Tomsk
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Sweden
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SE
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Ankara
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United Kingdom
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United Kingdom
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United States of America
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United States of America
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United States of America
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United States of America
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United States of America
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United States of America
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Guangzhou
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France
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France
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France
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France
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France
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France
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Belgium
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France
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France
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Tours Cedex 9
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France
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Germany
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Münster
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France
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France
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Rennes
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Germany
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Ulm
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France
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Villejuif
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Russian Federation
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Israel
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Tel Aviv
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Russian Federation
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Saint-Petersburg
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Spain
State/province [199] 0 0
Navarra
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Italy
State/province [200] 0 0
Milano
Country [201] 0 0
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Chuo Ku
Country [202] 0 0
Japan
State/province [202] 0 0
Isehara
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Japan
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Nagoya-shi
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Spain
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Badalona, Barcelona
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Spain
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Pamplona
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Spain
State/province [206] 0 0
Pozuelo de Alarcon
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Spain
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Spain
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Santander
Country [209] 0 0
United Kingdom
State/province [209] 0 0
London
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State/province [210] 0 0
Christchurch
Country [211] 0 0
New Zealand
State/province [211] 0 0
Dunedin
Country [212] 0 0
New Zealand
State/province [212] 0 0
Hamilton
Country [213] 0 0
New Zealand
State/province [213] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University Medical Center Groningen
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Boston Children's Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University Hospitals Cleveland Medical Center
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03920267