Trial Outcomes & Findings for Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis. (NCT NCT03610516)

Last Updated: 2024-10-09

Results Overview

Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs led to study treatment discontinuation, SAEs and SAEs led to study treatment discontinuation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

57 participants

Primary outcome timeframe

Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.

Results posted on

2024-10-09

Participant Flow

Participants took part in 21 investigative sites in 10 countries.

There was a screening period within 29 days to assess participants eligibility. After last dose of study treatment patients could enter the post-treatment follow-up.

Participant milestones

Participant milestones
Measure	CFZ533 10 mg/kg i.v. CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Placebo i.v. Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141
Treatment Epoch STARTED	39	18
Treatment Epoch COMPLETED	21	10
Treatment Epoch NOT COMPLETED	18	8
Post-Treatment Follow-up STARTED	34	16
Post-Treatment Follow-up COMPLETED	32	16
Post-Treatment Follow-up NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	CFZ533 10 mg/kg i.v. CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Placebo i.v. Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141
Treatment Epoch Adverse Event	3	1
Treatment Epoch Death	1	0
Treatment Epoch Lack of Efficacy	0	1
Treatment Epoch No longer requires treatment	1	0
Treatment Epoch Non-Compliance with study treatment	1	0
Treatment Epoch Physician Decision	8	5
Treatment Epoch Protocol Deviation	1	0
Treatment Epoch Withdrawal by Subject	3	1
Post-Treatment Follow-up Subject/Guardian Decision	1	0
Post-Treatment Follow-up Death	1	0

Baseline Characteristics

Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CFZ533 10 mg/kg i.v. n=39 Participants CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Placebo i.v. n=18 Participants Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Total n=57 Participants Total of all reporting groups
Age, Continuous	34.1 years STANDARD_DEVIATION 9.20 • n=5 Participants	36.4 years STANDARD_DEVIATION 9.15 • n=7 Participants	34.8 years STANDARD_DEVIATION 9.17 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	17 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized White	16 Participants n=5 Participants	7 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Asian	23 Participants n=5 Participants	11 Participants n=7 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.

Population: The safety analysis set included all participants who received any study drug.

Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs led to study treatment discontinuation, SAEs and SAEs led to study treatment discontinuation.

Outcome measures

Outcome measures
Measure	CFZ533 10 mg/kg i.v. n=39 Participants CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Placebo i.v. n=18 Participants Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Adverse Events	33 Participants	18 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Serious Adverse Events	6 Participants	3 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs leading to discontinuation of study treatment	3 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs leading to discontinuation of study treatment	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline, Day 169

Population: Participants in the pharmacodynamics (PD) analysis set with an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data.

A urine protein creatinine ratio (UPCR) test is a urine test. It measures the levels of protein and creatinine in urine. UPCR was assessed using the first morning void if available at a visit otherwise using the clinic spot sample, and was expressed as protein/creatinine (mg/mmol). High UPCR values can be a sign of kidney disease. An UPCR ratio to baseline \<1 indicates improvement from baseline.

Outcome measures

Outcome measures
Measure	CFZ533 10 mg/kg i.v. n=20 Participants CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Placebo i.v. n=10 Participants Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141
Ratio to Baseline in Urinary Protein Creatinine Ratio (UPCR)	0.369 ratio to baseline in UPCR Interval 0.234 to 0.582	0.637 ratio to baseline in UPCR Interval 0.338 to 1.202

SECONDARY outcome

Timeframe: Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 (End of Study)

Outcome measures

Outcome measures
Measure	CFZ533 10 mg/kg i.v. n=35 Participants CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Placebo i.v. n=16 Participants Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141
Ratio to Baseline for Urine Protein Creatinine Ratio (UPCR) Day 197	0.532 ratio to baseline in UPCR Standard Deviation 0.4160	0.985 ratio to baseline in UPCR Standard Deviation 0.9045
Ratio to Baseline for Urine Protein Creatinine Ratio (UPCR) Day 225	0.456 ratio to baseline in UPCR Standard Deviation 0.3876	1.153 ratio to baseline in UPCR Standard Deviation 1.2178
Ratio to Baseline for Urine Protein Creatinine Ratio (UPCR) Day 253	0.648 ratio to baseline in UPCR Standard Deviation 1.3314	0.667 ratio to baseline in UPCR Standard Deviation 0.3612
Ratio to Baseline for Urine Protein Creatinine Ratio (UPCR) Day 281	0.526 ratio to baseline in UPCR Standard Deviation 0.5440	0.701 ratio to baseline in UPCR Standard Deviation 0.7690
Ratio to Baseline for Urine Protein Creatinine Ratio (UPCR) Day 309	0.580 ratio to baseline in UPCR Standard Deviation 0.7175	1.101 ratio to baseline in UPCR Standard Deviation 1.1337
Ratio to Baseline for Urine Protein Creatinine Ratio (UPCR) Day 337	0.640 ratio to baseline in UPCR Standard Deviation 0.7446	0.735 ratio to baseline in UPCR Standard Deviation 0.5323

SECONDARY outcome

Timeframe: Day 141: pre dose and 1 hour post dose

Population: Participants in the Pharmacokinetic (PK) analysis set with an available value for the outcome measure. The (PK) analysis set included all subjects with at least one available valid PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data. The PK analysis set is only applicable to the CFZ533 arm.

Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis. AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of free CFZ533.

Outcome measures

Outcome measures
Measure	CFZ533 10 mg/kg i.v. n=11 Participants CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Placebo i.v. Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141
Area Under Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of CFZ533	7250 day*ug/mL Standard Deviation 1800	—

SECONDARY outcome

Timeframe: Pre-dose at: Day 1, Day 15, Day 29, Day 57, Day 85, Day 113 and Day 141

Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis. Ctrough is the observed plasma concentration that is just prior to the beginning of, or at the end of a dosing interval.

Outcome measures

Outcome measures
Measure	CFZ533 10 mg/kg i.v. n=33 Participants CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Placebo i.v. Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141
Pre-dose Trough Concentration (Ctrough) of CFZ533 Day 1	0 ug/mL Standard Deviation 0	—
Pre-dose Trough Concentration (Ctrough) of CFZ533 Day 15	49.8 ug/mL Standard Deviation 37.0	—
Pre-dose Trough Concentration (Ctrough) of CFZ533 Day 29	64.1 ug/mL Standard Deviation 31.6	—
Pre-dose Trough Concentration (Ctrough) of CFZ533 Day 57	34.5 ug/mL Standard Deviation 21.7	—
Pre-dose Trough Concentration (Ctrough) of CFZ533 Day 85	33.2 ug/mL Standard Deviation 25.0	—
Pre-dose Trough Concentration (Ctrough) of CFZ533 Day 113	32.7 ug/mL Standard Deviation 26.3	—
Pre-dose Trough Concentration (Ctrough) of CFZ533 Day 141	34.1 ug/mL Standard Deviation 26.6	—

SECONDARY outcome

Timeframe: Day 141: pre dose and 1 hour post dose

Population: Participants in the Pharmacokinetic (PK) analysis set with an available value for the outcome measure. The PK analysis set included all subjects with at least one available valid PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data. The PK analysis set is only applicable to the CFZ533 arm.

Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis. Cmax,ss is the observed maximum plasma concentration following CFZ533 administration at steady state \[mass/volume\].

Outcome measures

Outcome measures
Measure	CFZ533 10 mg/kg i.v. n=20 Participants CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Placebo i.v. Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141
The Observed Maximum Plasma Concentration Following CFZ533 Administration at Steady State (Cmax,ss)	263 ug/mL Standard Deviation 81.8	—

SECONDARY outcome

Timeframe: Day 1, Day 15, Day 29, Day 57, Day 113, Day 169, Day 225, Day 281, Day 337 (End of Study)

Population: Participants in the Pharmacodynamics (PD) analysis set who received CFZ533 and had an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data.

Total soluble CD40 concentrations in plasma. An increase in soluble CD40 concentrations is considered a marker for CFZ533 target engagement. This endpoint is only applicable to the CFZ533 arm.

Outcome measures

Outcome measures
Measure	CFZ533 10 mg/kg i.v. n=30 Participants CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Placebo i.v. Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141
Total Soluble CD40 Plasma Concentrations Day 1	0.2723 ng/mL Standard Deviation 0.22222	—
Total Soluble CD40 Plasma Concentrations Day 15	78.7375 ng/mL Standard Deviation 20.58802	—
Total Soluble CD40 Plasma Concentrations Day 29	90.4286 ng/mL Standard Deviation 23.86165	—
Total Soluble CD40 Plasma Concentrations Day 57	127.6214 ng/mL Standard Deviation 26.11617	—
Total Soluble CD40 Plasma Concentrations Day 113	109.2672 ng/mL Standard Deviation 50.19834	—
Total Soluble CD40 Plasma Concentrations Day 169	158.5714 ng/mL Standard Deviation 22.24753	—
Total Soluble CD40 Plasma Concentrations Day 225	8.3406 ng/mL Standard Deviation 17.77703	—
Total Soluble CD40 Plasma Concentrations Day 281	0.7981 ng/mL Standard Deviation 0.32464	—
Total Soluble CD40 Plasma Concentrations Day 337 (End of Study)	0.5331 ng/mL Standard Deviation 0.30080	—

SECONDARY outcome

Timeframe: Day 1, Day 15, Day 29, Day 57, Day 113, Day 169, Day 225, Day 281, Day 337 (End of study)

To evaluate the immunogenicity of CFZ533 via the quasi-quantitative analysis of anti-CFZ533 antibodies.

Outcome measures

Outcome measures
Measure	CFZ533 10 mg/kg i.v. n=33 Participants CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Placebo i.v. n=16 Participants Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141
Number of Participants With Anti-CFZ533 Antibodies Day 169-Negative	14 Participants	8 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 169-Positive	0 Participants	0 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 281-Positive	1 Participants	0 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 337-Negative (EOS)	12 Participants	8 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 1-Negative	32 Participants	13 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 1-Positive	1 Participants	0 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 15-Negative	17 Participants	8 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 15-Positive	0 Participants	0 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 29-Negative	33 Participants	16 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 29-Positive	0 Participants	0 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 57-Negative	17 Participants	8 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 57-Positive	0 Participants	0 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 113-Negative	32 Participants	15 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 113-Positive	0 Participants	0 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 225-Negative	25 Participants	13 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 225-Positive	1 Participants	0 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 281-Negative	23 Participants	13 Participants
Number of Participants With Anti-CFZ533 Antibodies Day 337-Positive (EOS)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Day 1 (Pre dose), and Day 309

Population: Participants in the pharmacodynamics (PD) analysis set with a microscopic urinalysis and an available value for the outcome measure at baseline and the corresponding time point. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data.

Urine was tested using a dipstick. If the dipstick result was positive for protein, nitrite, leucocytes and/or blood, a microscopic analysis of white blood cells (WBC), red blood cells (RBC) and casts was performed. Hematuria is the presence of blood in the urine. Hematuria casts were assessed by microscopic urinalysis and classified as granular casts and WBC casts. Only in the event of a positive result, these samples were submitted to reflex testing microscopic analysis for counting of casts which resulted in a numeric value related to the number of respective casts presented in the urine.

Outcome measures

Outcome measures
Measure	CFZ533 10 mg/kg i.v. n=37 Participants CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Placebo i.v. n=18 Participants Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141
Hematuria Casts- Urine White Blood Cell Casts Baseline	2 number of casts per low power field	—
Hematuria Casts- Urine White Blood Cell Casts Day 1	2 number of casts per low power field	—
Hematuria Casts- Urine White Blood Cell Casts Day 309	4 number of casts per low power field	—

SECONDARY outcome

Timeframe: Day 1 (Pre dose), Day 15 (Pre dose), Day 29 (Pre dose), Day 253, and Day 337 (end of study)

Outcome measures

Outcome measures
Measure	CFZ533 10 mg/kg i.v. n=37 Participants CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Placebo i.v. n=18 Participants Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141
Hematuria Casts- Casts Granular Day 1	3 number of casts per low power field	—
Hematuria Casts- Casts Granular Day 15	2.5 number of casts per low power field Standard Deviation 0.71	—
Hematuria Casts- Casts Granular Day 29	—	3 number of casts per low power field Standard Deviation 1.41
Hematuria Casts- Casts Granular Day 253	14.0 number of casts per low power field	—
Hematuria Casts- Casts Granular Day 337 (End of Study)	5 number of casts per low power field Standard Deviation 2.83	—

SECONDARY outcome

Timeframe: Baseline, Day 1 (Pre dose), Day 15 (Pre dose), Day 29 (Pre dose), Day 57 (Pre dose), Day 85 (Pre dose), Day 113 (Pre dose), Day 141 (Pre dose), Day 169, Day 197, Day 225, Day 253, Day 281, Day 309 and Day 337 (end of study)

Outcome measures

Outcome measures
Measure	CFZ533 10 mg/kg i.v. n=37 Participants CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Placebo i.v. n=18 Participants Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141
Change From Baseline in Urine Hyaline Casts Day 15	8.3 number of casts per low power field Standard Deviation 15.88	3.7 number of casts per low power field Standard Deviation 3.51
Change From Baseline in Urine Hyaline Casts Day 29	2.8 number of casts per low power field Standard Deviation 4.99	5.0 number of casts per low power field Standard Deviation 2.16
Change From Baseline in Urine Hyaline Casts Day 57	-5.0 number of casts per low power field Standard Deviation 3.61	1.0 number of casts per low power field Standard Deviation 1.41
Change From Baseline in Urine Hyaline Casts Day 85	0.5 number of casts per low power field Standard Deviation 2.12	-4.0 number of casts per low power field
Change From Baseline in Urine Hyaline Casts Day 113	—	18.0 number of casts per low power field Standard Deviation 28.58
Change From Baseline in Urine Hyaline Casts Day 141	—	-4.5 number of casts per low power field Standard Deviation 6.36
Change From Baseline in Urine Hyaline Casts Day 169	0.0 number of casts per low power field	0.0 number of casts per low power field
Change From Baseline in Urine Hyaline Casts Day 197	-1.0 number of casts per low power field Standard Deviation 2.65	2.7 number of casts per low power field Standard Deviation 9.02
Change From Baseline in Urine Hyaline Casts Day 225	2.0 number of casts per low power field	0.0 number of casts per low power field
Change From Baseline in Urine Hyaline Casts Day 253	—	-0.5 number of casts per low power field Standard Deviation 4.95
Change From Baseline in Urine Hyaline Casts Day 281	0.0 number of casts per low power field	-1.5 number of casts per low power field Standard Deviation 4.95
Change From Baseline in Urine Hyaline Casts Day 309	1.7 number of casts per low power field Standard Deviation 1.15	-4.0 number of casts per low power field
Change From Baseline in Urine Hyaline Casts Day 337 (EOS)	—	0.5 number of casts per low power field Standard Deviation 0.71

SECONDARY outcome

Timeframe: Baseline, up to Day 169

The criteria for CRR were defined as: 1. Urinary protein creatinine ratio (UPCR) ≤ 0.2 mg/mg 2. Estimated glomerular filtration rate (eGFR) ≤ 25% of Baseline 3. Normal urine sediment. If the UPCR from the first morning void sample was not available, then the UPCR from the corresponding spot sample taken at the investigator site was used in the derivation of complete renal remission.

Outcome measures

Outcome measures
Measure	CFZ533 10 mg/kg i.v. n=37 Participants CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Placebo i.v. n=18 Participants Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141
Number of Participants Who Fulfil the Criteria for Complete Renal Remission (CRR)	13 Participants	4 Participants

Adverse Events

CCFZ533 10mg/kg

Serious events: 6 serious events

Other events: 32 other events

Deaths: 2 deaths

Placebo i.v.

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

All Patients

Serious events: 9 serious events

Other events: 50 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	CCFZ533 10mg/kg n=39 participants at risk CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	Placebo i.v. n=18 participants at risk Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141	All Patients n=57 participants at risk All patients
Hepatobiliary disorders Cholecystitis	0.00% 0/39 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	5.6% 1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	1.8% 1/57 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.
Immune system disorders Haemophagocytic lymphohistiocytosis	2.6% 1/39 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	0.00% 0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	1.8% 1/57 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.
Infections and infestations Bronchitis	2.6% 1/39 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	0.00% 0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	1.8% 1/57 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.
Infections and infestations Cytomegalovirus infection reactivation	2.6% 1/39 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	0.00% 0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	1.8% 1/57 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.
Infections and infestations Gastroenteritis	2.6% 1/39 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	0.00% 0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	1.8% 1/57 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.
Infections and infestations Pneumonia	2.6% 1/39 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	0.00% 0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	1.8% 1/57 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.
Infections and infestations Urinary tract infection	2.6% 1/39 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	0.00% 0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	1.8% 1/57 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.
Infections and infestations Urosepsis	2.6% 1/39 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	0.00% 0/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	1.8% 1/57 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/39 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	5.6% 1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	1.8% 1/57 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.
Psychiatric disorders Suicidal behaviour	0.00% 0/39 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	5.6% 1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	1.8% 1/57 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.
Renal and urinary disorders Lupus nephritis	0.00% 0/39 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	5.6% 1/18 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.	1.8% 1/57 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER