Trial Outcomes & Findings for Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy (NCT NCT03804879)

Last Updated: 2022-08-10

Results Overview

UACR is a ratio between albumin and creatinine, and it estimates 24-hour urine albumin excretion. UACR (mg/mmol) = urine albumin \[mg/L\] / urine creatinine \[mmol/L\]. UACR was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

83 participants

Primary outcome timeframe

Baseline and days 14, 29, 57, 85, 113, 141 and 169

Results posted on

2022-08-10

Participant Flow

Participants were recruited from 18 sites in 7 countries.

Participants underwent a Screening period of up to 30 days which included screening and baseline assessments.

Participant milestones

Participant milestones
Measure	LMB763 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo Placebo was orally administered once daily for 24 weeks in addition to SoC.
Overall Study STARTED	41	42
Overall Study Pharmacokinetics (PK) Analysis Set	41	0
Overall Study Pharmacodynamics (PD) Analysis Set	41	41
Overall Study COMPLETED	25	29
Overall Study NOT COMPLETED	16	13

Reasons for withdrawal

Reasons for withdrawal
Measure	LMB763 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo Placebo was orally administered once daily for 24 weeks in addition to SoC.
Overall Study Adverse Event	3	0
Overall Study Study Terminated By Sponsor	10	12
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LMB763 n=41 Participants 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo n=42 Participants Placebo was orally administered once daily for 24 weeks in addition to SoC.	Total n=83 Participants Total of all reporting groups
Age, Continuous	60.8 Years STANDARD_DEVIATION 8.95 • n=5 Participants	61.6 Years STANDARD_DEVIATION 8.36 • n=7 Participants	61.2 Years STANDARD_DEVIATION 8.61 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	32 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants	41 Participants n=7 Participants	82 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and days 14, 29, 57, 85, 113, 141 and 169

Population: All randomized participants. At each time point, only participants with a value at both baseline and that time point were included.

Outcome measures

Outcome measures
Measure	LMB763 n=41 Participants 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo n=42 Participants Placebo was orally administered once daily for 24 weeks in addition to SoC.
Ratio to Baseline in Urinary Albumin to Creatinine Ratio (UACR) Day 169	0.74 Ratio to baseline Interval 0.61 to 0.89	0.92 Ratio to baseline Interval 0.78 to 1.1
Ratio to Baseline in Urinary Albumin to Creatinine Ratio (UACR) Day 14	0.90 Ratio to baseline Interval 0.79 to 1.02	1.06 Ratio to baseline Interval 0.94 to 1.2
Ratio to Baseline in Urinary Albumin to Creatinine Ratio (UACR) Day 29	0.83 Ratio to baseline Interval 0.75 to 0.93	1.00 Ratio to baseline Interval 0.9 to 1.12
Ratio to Baseline in Urinary Albumin to Creatinine Ratio (UACR) Day 57	0.85 Ratio to baseline Interval 0.76 to 0.94	1.05 Ratio to baseline Interval 0.95 to 1.17
Ratio to Baseline in Urinary Albumin to Creatinine Ratio (UACR) Day 85	0.84 Ratio to baseline Interval 0.72 to 0.97	1.07 Ratio to baseline Interval 0.93 to 1.23
Ratio to Baseline in Urinary Albumin to Creatinine Ratio (UACR) Day 113	0.87 Ratio to baseline Interval 0.73 to 1.04	1.07 Ratio to baseline Interval 0.9 to 1.26
Ratio to Baseline in Urinary Albumin to Creatinine Ratio (UACR) Day 141	0.84 Ratio to baseline Interval 0.71 to 1.01	1.15 Ratio to baseline Interval 0.98 to 1.35

PRIMARY outcome

Timeframe: Baseline and day 169

Population: Pharmacodynamics (PD) analysis set. Only participants with a value at both baseline and at Day 169 were included.

Albuminuria describes the existence of albumin in the urine and the gold-standard to assess albuminuria is 24-hour urinary albumin excretion (milligram/24 hours). An analysis of covariance (ANCOVA) with treatment as the classification factor and log-transformed baseline as the covariate was conducted for log-transformed ratio to baseline 24-hour urinary albumin excretion. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.

Outcome measures

Outcome measures
Measure	LMB763 n=17 Participants 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo n=21 Participants Placebo was orally administered once daily for 24 weeks in addition to SoC.
Ratio to Baseline in 24 Hour Urinary Albumin at Week 24 (Day 169)	0.58 Ratio to baseline Interval 0.45 to 0.74	0.91 Ratio to baseline Interval 0.72 to 1.14

PRIMARY outcome

Timeframe: From the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days

Population: All randomized participants

Number of participants with AEs and SAEs including significant changes from baseline in vital signs, electrocardiograms and laboratory values qualifying and reported as AEs. The category Number of participants with AEs includes also the number of participants with SAEs. The number of participants in each category is reported in the table.

Outcome measures

Outcome measures
Measure	LMB763 n=41 Participants 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo n=42 Participants Placebo was orally administered once daily for 24 weeks in addition to SoC.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	29 Participants	25 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline and days 14, 29, 57, 85, 113, 141 and 169

Population: Pharmacodynamics (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included.

Estimate Glomerular Filtration Rate (GFR) calculates estimated GFR (eGFR) from serum creatinine levels to assess kidney function. eGFR (milliliter/minute) was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A higher score in the ratio to baseline indicates improvement.

Outcome measures

Outcome measures
Measure	LMB763 n=41 Participants 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo n=41 Participants Placebo was orally administered once daily for 24 weeks in addition to SoC.
Ratio to Baseline in Estimated Glomerular Filtration Rate (eGFR) Day 113	0.96 Ratio Interval 0.92 to 0.99	0.94 Ratio Interval 0.91 to 0.98
Ratio to Baseline in Estimated Glomerular Filtration Rate (eGFR) Day 141	0.98 Ratio Interval 0.95 to 1.02	0.93 Ratio Interval 0.9 to 0.96
Ratio to Baseline in Estimated Glomerular Filtration Rate (eGFR) Day 169	0.93 Ratio Interval 0.89 to 0.97	0.93 Ratio Interval 0.9 to 0.97
Ratio to Baseline in Estimated Glomerular Filtration Rate (eGFR) Day 14	0.95 Ratio Interval 0.93 to 0.98	0.96 Ratio Interval 0.94 to 0.99
Ratio to Baseline in Estimated Glomerular Filtration Rate (eGFR) Day 29	0.94 Ratio Interval 0.91 to 0.97	0.94 Ratio Interval 0.91 to 0.97
Ratio to Baseline in Estimated Glomerular Filtration Rate (eGFR) Day 57	0.98 Ratio Interval 0.95 to 1.02	0.96 Ratio Interval 0.93 to 1.0
Ratio to Baseline in Estimated Glomerular Filtration Rate (eGFR) Day 85	0.97 Ratio Interval 0.93 to 1.01	0.94 Ratio Interval 0.9 to 0.97

SECONDARY outcome

Timeframe: pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14

Population: Pharmacokinetics (PK) analysis set

Pharmacokinetic (PK) parameters were calculated based on LMB763 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Cmax was determined using non-compartmental methods. No methods for imputation of missing data were used.

Outcome measures

Outcome measures
Measure	LMB763 n=41 Participants 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo Placebo was orally administered once daily for 24 weeks in addition to SoC.
Maximum Peak Observed Concentration (Cmax) of LMB763 Day 1	1090 Nanogram/milliliter Standard Deviation 665	—
Maximum Peak Observed Concentration (Cmax) of LMB763 Day 14	1300 Nanogram/milliliter Standard Deviation 691	—

SECONDARY outcome

Timeframe: pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14

Population: Pharmacokinetics (PK) analysis set

Pharmacokinetic (PK) parameters were calculated based on LMB763 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Tmax was determined using non-compartmental methods. Actual time of sample collection was used (not the nominal time point as per scheduled assessment). No methods for imputation of missing data were used.

Outcome measures

Outcome measures
Measure	LMB763 n=41 Participants 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo Placebo was orally administered once daily for 24 weeks in addition to SoC.
Time to Reach Maximum Blood Concentrations (Tmax) of LMB763 Day 1	3.25 Hour Interval 0.75 to 6.0	—
Time to Reach Maximum Blood Concentrations (Tmax) of LMB763 Day 14	2 Hour Interval 0.0 to 6.0	—

SECONDARY outcome

Timeframe: pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14

Population: Pharmacokinetics (PK) analysis set

Pharmacokinetic (PK) parameters were calculated based on LMB763 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. AUClast was determined using non-compartmental methods. No methods for imputation of missing data were used.

Outcome measures

Outcome measures
Measure	LMB763 n=41 Participants 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo Placebo was orally administered once daily for 24 weeks in addition to SoC.
Area Under the Blood Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of LMB763 Day 1	3710 Hour*nanogram/milliliter Standard Deviation 2510	—
Area Under the Blood Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of LMB763 Day 14	4850 Hour*nanogram/milliliter Standard Deviation 2910	—

SECONDARY outcome

Timeframe: Baseline and day 169

Population: Pharmacodynamics (PD) analysis set. Only participants with a value at both baseline and at Day 169 were included.

The free water clearance (mL/min) was calculated using the following formula: (Total Volume (mL) / Elapsed Date \& Time (min)) \* (1-24 hr Urine Osmolality (mOsmol/kg)/ Serum Osmolality (mOsmol/kg)) The result of free water clearance was rounded to one decimal place prior to statistical analysis. An analysis of covariance (ANCOVA) with treatment as the classification factor and log-transformed baseline as the covariate was conducted for log-transformed ratio to baseline free water clearance. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A higher score in the ratio to baseline indicates improvement.

Outcome measures

Outcome measures
Measure	LMB763 n=8 Participants 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo n=11 Participants Placebo was orally administered once daily for 24 weeks in addition to SoC.
Ratio to Baseline in Free Water Clearance	0.97 Ratio Interval 0.86 to 1.1	0.97 Ratio Interval 0.88 to 1.08

SECONDARY outcome

Timeframe: Baseline and day 85

Population: Pharmacodynamics (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included.

Lipoprotein A (gram/liter) is a component of the lipid profile which is a panel of blood tests used to find abnormalities in lipids. Ratio to baseline in Lipoprotein A was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.

Outcome measures

Outcome measures
Measure	LMB763 n=19 Participants 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo n=24 Participants Placebo was orally administered once daily for 24 weeks in addition to SoC.
Ratio to Baseline in Lipoprotein A at Day 85	0.72 Ratio Interval 0.67 to 0.77	0.95 Ratio Interval 0.9 to 1.01

SECONDARY outcome

Timeframe: Baseline and day 169

Population: Pharmacodynamics (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included.

Outcome measures

Outcome measures
Measure	LMB763 n=12 Participants 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo n=19 Participants Placebo was orally administered once daily for 24 weeks in addition to SoC.
Ratio to Baseline in Lipoprotein A at Day 169	0.75 Ratio to baseline Interval 0.66 to 0.85	0.89 Ratio to baseline Interval 0.81 to 0.99

SECONDARY outcome

Timeframe: Baseline and days 14, 29, 57, 85, 113, 141 and 169

Population: Pharmacodynamics (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included.

Change from baseline in weight was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A negative score in the percent change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	LMB763 n=41 Participants 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo n=41 Participants Placebo was orally administered once daily for 24 weeks in addition to SoC.
Percent Change From Baseline in Weight Day 113	-0.51 Percent change Interval -1.42 to 0.4	0.21 Percent change Interval -0.67 to 1.09
Percent Change From Baseline in Weight Day 14	-0.08 Percent change Interval -0.45 to 0.29	-0.13 Percent change Interval -0.5 to 0.23
Percent Change From Baseline in Weight Day 29	-0.57 Percent change Interval -0.99 to -0.14	-0.03 Percent change Interval -0.45 to 0.39
Percent Change From Baseline in Weight Day 57	-0.69 Percent change Interval -1.35 to -0.04	-0.24 Percent change Interval -0.9 to 0.41
Percent Change From Baseline in Weight Day 85	-0.41 Percent change Interval -1.21 to 0.38	0.08 Percent change Interval -0.7 to 0.86
Percent Change From Baseline in Weight Day 141	-0.80 Percent change Interval -1.69 to 0.09	0.43 Percent change Interval -0.44 to 1.29
Percent Change From Baseline in Weight Day 169	-0.61 Percent change Interval -1.6 to 0.39	0.55 Percent change Interval -0.38 to 1.47

SECONDARY outcome

Timeframe: Baseline and days 14, 29, 57, 85, 113, 141 and 169

Population: Pharmacodynamics (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included.

BMI was determined by height and weight measurements: Body weight (kg)/ \[Height (m)\]\^2. Change from baseline in BMI was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A negative score in the percent change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	LMB763 n=41 Participants 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo n=41 Participants Placebo was orally administered once daily for 24 weeks in addition to SoC.
Percent Change From Baseline in Body Mass Index (BMI) Day 57	-0.23 Percent change Interval -0.44 to -0.02	-0.07 Percent change Interval -0.28 to 0.14
Percent Change From Baseline in Body Mass Index (BMI) Day 85	-0.13 Percent change Interval -0.4 to 0.13	0.03 Percent change Interval -0.22 to 0.29
Percent Change From Baseline in Body Mass Index (BMI) Day 14	-0.01 Percent change Interval -0.12 to 0.1	-0.05 Percent change Interval -0.16 to 0.06
Percent Change From Baseline in Body Mass Index (BMI) Day 29	-0.19 Percent change Interval -0.32 to -0.05	-0.02 Percent change Interval -0.15 to 0.12
Percent Change From Baseline in Body Mass Index (BMI) Day 113	-0.18 Percent change Interval -0.47 to 0.12	0.07 Percent change Interval -0.21 to 0.35
Percent Change From Baseline in Body Mass Index (BMI) Day 141	-0.31 Percent change Interval -0.6 to -0.01	0.16 Percent change Interval -0.12 to 0.45
Percent Change From Baseline in Body Mass Index (BMI) Day 169	-0.29 Percent change Interval -0.61 to 0.04	0.16 Percent change Interval -0.15 to 0.47

SECONDARY outcome

Timeframe: Baseline and days 14, 29, 57, 85, 113, 141 and 169

Population: Pharmacodynamics (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included.

Waist-to-hip ratio was derived using waist circumference and hip circumference, which was measured at the greatest protrusion of the buttocks. Change from baseline in waist-to-hip ratio was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A negative score in the change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	LMB763 n=41 Participants 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo n=41 Participants Placebo was orally administered once daily for 24 weeks in addition to SoC.
Change From Baseline in Waist-to-hip Ratio Day 14	-0.00 Ratio Interval -0.01 to 0.0	-0.00 Ratio Interval -0.01 to 0.0
Change From Baseline in Waist-to-hip Ratio Day 29	-0.00 Ratio Interval -0.01 to 0.0	0.00 Ratio Interval 0.0 to 0.01
Change From Baseline in Waist-to-hip Ratio Day 57	-0.00 Ratio Interval -0.01 to 0.0	0.00 Ratio Interval -0.01 to 0.01
Change From Baseline in Waist-to-hip Ratio Day 85	-0.00 Ratio Interval -0.01 to 0.0	0.01 Ratio Interval 0.0 to 0.01
Change From Baseline in Waist-to-hip Ratio Day 113	-0.00 Ratio Interval -0.01 to 0.01	0.01 Ratio Interval 0.0 to 0.02
Change From Baseline in Waist-to-hip Ratio Day 141	-0.00 Ratio Interval -0.01 to 0.01	0.02 Ratio Interval 0.01 to 0.03
Change From Baseline in Waist-to-hip Ratio Day 169	-0.00 Ratio Interval -0.01 to 0.01	-0.00 Ratio Interval -0.01 to 0.0

Adverse Events

LMB763

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Total

Serious events: 4 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LMB763 n=41 participants at risk 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.	Placebo n=42 participants at risk Placebo was orally administered once daily for 24 weeks in addition to SoC.	Total n=83 participants at risk Total
Infections and infestations Erysipelas	2.4% 1/41 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment	0.00% 0/42 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment	1.2% 1/83 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
Metabolism and nutrition disorders Hyperglycaemia	2.4% 1/41 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment	0.00% 0/42 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment	1.2% 1/83 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/41 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment	2.4% 1/42 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment	1.2% 1/83 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
Renal and urinary disorders Renal disorder	0.00% 0/41 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment	2.4% 1/42 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment	1.2% 1/83 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
Skin and subcutaneous tissue disorders Dermatitis atopic	2.4% 1/41 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment	0.00% 0/42 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment	1.2% 1/83 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
Renal and urinary disorders Acute kidney injury	2.4% 1/41 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment	0.00% 0/42 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment	1.2% 1/83 • Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days Any sign or symptom that occurs during the study treatment plus the 28 days post treatment

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