Trial Outcomes & Findings for Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy (NCT NCT03608033)

Last Updated: 2025-12-09

Results Overview

The Primary Endpoint of this Study is the Percent Change from Baseline in Log-transformed 24-hour UPE in g/Day at 36 Weeks in Patients with High Baseline Proteinuria (High-risk Proteinuria Group; 24-hour UPE ≥ 2 g/day.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

360 participants

Primary outcome timeframe

36 Weeks

Results posted on

2025-12-09

Participant Flow

Patients with 24-hour UPE \> 2 g/day at baseline will be allowed to receive 12-weeks of open-label active drug (OMS721) on Week 72 (18 months post randomization), provided they meet certain criteria: * Less than 30% reduction in UPE at the OL assessment visit from baseline UPE * Proteinuria is ≥ 3.0 g/day at 72 weeks from randomization, confirmed by 2 measurements at least 2 weeks apart, but \< 3 weeks * Worsening renal function, defined as a decline in eGFR of \> 5 mL/min/m\^2 from baseline

Participant milestones

Participant milestones
Measure	OMS721 Administration of OMS721 OMS721: Biological: OMS721	Placebo Administration of Vehicle (D5W or Saline Solution) Vehicle (D5W or saline): 5% Dextrose in water or normal saline solution
Treatment Period STARTED	181	179
Treatment Period COMPLETED	37	39
Treatment Period NOT COMPLETED	144	140
Open-Label Period: OMS721 STARTED	34	0
Open-Label Period: OMS721 COMPLETED	15	0
Open-Label Period: OMS721 NOT COMPLETED	19	0

Reasons for withdrawal

Reasons for withdrawal
Measure	OMS721 Administration of OMS721 OMS721: Biological: OMS721	Placebo Administration of Vehicle (D5W or Saline Solution) Vehicle (D5W or saline): 5% Dextrose in water or normal saline solution
Treatment Period Death	0	1
Treatment Period Adverse Event	1	5
Treatment Period Lack of Efficacy	4	3
Treatment Period Lost to Follow-up	2	6
Treatment Period Physician Decision	6	10
Treatment Period Pregnancy	1	0
Treatment Period Protocol Violation	1	2
Treatment Period Withdrawal by Subject	46	45
Treatment Period Study terminated by sponsor	82	68
Treatment Period Site Terminated by Sponsor	1	0
Open-Label Period: OMS721 Adverse Event	1	0
Open-Label Period: OMS721 Lack of Efficacy	1	0
Open-Label Period: OMS721 Lost to Follow-up	1	0
Open-Label Period: OMS721 Study Terminated By Sponsor	11	0
Open-Label Period: OMS721 Withdrawal by Subject	5	0

Baseline Characteristics

Two participants were treated with OMS721 without following appropriate randomization procedures resulting in major protocol deviations. Thus, these participants were not included in the analysis population. One participant in the placebo group was randomized but did not have weight collected.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OMS721 n=181 Participants Administration of OMS721 OMS721: Biological: OMS721	Placebo n=179 Participants Administration of Vehicle (D5W or Saline Solution) Vehicle (D5W or saline): 5% Dextrose in water or normal saline solution	Total n=360 Participants Total of all reporting groups
Age, Continuous Mean (SD)	40.7 years STANDARD_DEVIATION 12.01 • n=181 Participants	41.6 years STANDARD_DEVIATION 12.76 • n=179 Participants	41.2 years STANDARD_DEVIATION 12.38 • n=360 Participants
Sex: Female, Male Female	67 Participants n=181 Participants	61 Participants n=179 Participants	128 Participants n=360 Participants
Sex: Female, Male Male	114 Participants n=181 Participants	118 Participants n=179 Participants	232 Participants n=360 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=181 Participants	11 Participants n=179 Participants	33 Participants n=360 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	157 Participants n=181 Participants	166 Participants n=179 Participants	323 Participants n=360 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=181 Participants	2 Participants n=179 Participants	4 Participants n=360 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=181 Participants	1 Participants n=179 Participants	2 Participants n=360 Participants
Race (NIH/OMB) Asian	52 Participants n=181 Participants	62 Participants n=179 Participants	114 Participants n=360 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=181 Participants	0 Participants n=179 Participants	0 Participants n=360 Participants
Race (NIH/OMB) Black or African American	3 Participants n=181 Participants	1 Participants n=179 Participants	4 Participants n=360 Participants
Race (NIH/OMB) White	120 Participants n=181 Participants	112 Participants n=179 Participants	232 Participants n=360 Participants
Race (NIH/OMB) More than one race	0 Participants n=181 Participants	0 Participants n=179 Participants	0 Participants n=360 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=181 Participants	3 Participants n=179 Participants	8 Participants n=360 Participants
Child Bearing Potential, n (%) Yes	49 participants n=181 Participants	45 participants n=179 Participants	94 participants n=360 Participants
Child Bearing Potential, n (%) No	18 participants n=181 Participants	16 participants n=179 Participants	34 participants n=360 Participants
Child Bearing Potential, n (%) Not Applicable (Male Subjects)	114 participants n=181 Participants	118 participants n=179 Participants	232 participants n=360 Participants
Baseline Weight (kg)	82.7 kg STANDARD_DEVIATION 19.95 • n=179 Participants • Two participants were treated with OMS721 without following appropriate randomization procedures resulting in major protocol deviations. Thus, these participants were not included in the analysis population. One participant in the placebo group was randomized but did not have weight collected.	82.5 kg STANDARD_DEVIATION 22.39 • n=178 Participants • Two participants were treated with OMS721 without following appropriate randomization procedures resulting in major protocol deviations. Thus, these participants were not included in the analysis population. One participant in the placebo group was randomized but did not have weight collected.	82.6 kg STANDARD_DEVIATION 21.17 • n=357 Participants • Two participants were treated with OMS721 without following appropriate randomization procedures resulting in major protocol deviations. Thus, these participants were not included in the analysis population. One participant in the placebo group was randomized but did not have weight collected.
Baseline Height (cm)	170.8 cm STANDARD_DEVIATION 9.39 • n=179 Participants • Two participants were treated with OMS721 without appropriate randomization procedures resulting in major protocol deviations. Thus, these participants were not included in this analysis. One subject in the placebo group was randomized but did not have height collected.	171.9 cm STANDARD_DEVIATION 10.10 • n=178 Participants • Two participants were treated with OMS721 without appropriate randomization procedures resulting in major protocol deviations. Thus, these participants were not included in this analysis. One subject in the placebo group was randomized but did not have height collected.	171.4 cm STANDARD_DEVIATION 9.75 • n=357 Participants • Two participants were treated with OMS721 without appropriate randomization procedures resulting in major protocol deviations. Thus, these participants were not included in this analysis. One subject in the placebo group was randomized but did not have height collected.
Baseline BMI (kg/m^2)	28.3 kg/m^2 STANDARD_DEVIATION 6.51 • n=179 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.	27.8 kg/m^2 STANDARD_DEVIATION 6.87 • n=179 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.	28.1 kg/m^2 STANDARD_DEVIATION 6.69 • n=358 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.
Baseline Systolic Blood Pressure (mmHG)	125.7 mmHg STANDARD_DEVIATION 10.13 • n=179 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.	124.8 mmHg STANDARD_DEVIATION 12.03 • n=179 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.	125.3 mmHg STANDARD_DEVIATION 11.11 • n=358 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.
Baseline Diastolic Blood Pressure (mmHG)	78.3 mmHg STANDARD_DEVIATION 8.3 • n=179 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.	77.8 mmHg STANDARD_DEVIATION 9.15 • n=179 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.	78.1 mmHg STANDARD_DEVIATION 8.72 • n=358 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.
Baseline Estimated Glomerular Filtration Rate (mL/min/SSA), n(%) Greater than or equal to 30 and Less than or equal to 45	63 participants n=179 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.	62 participants n=179 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.	125 participants n=358 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.
Baseline Estimated Glomerular Filtration Rate (mL/min/SSA), n(%) Greater than 45	116 participants n=179 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.	117 participants n=179 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.	233 participants n=358 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.
Baseline Urine Protein Excretion Rate (mg/24hrs)	2780.5 mg/24hrs STANDARD_DEVIATION 1633.49 • n=179 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.	2869.3 mg/24hrs STANDARD_DEVIATION 1802 • n=179 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.	2824.9 mg/24hrs STANDARD_DEVIATION 1717.98 • n=358 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.
Baseline Urine Protein Creatinine Ratio	2.0 (g/g) STANDARD_DEVIATION 1.21 • n=179 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.	2.1 (g/g) STANDARD_DEVIATION 1.19 • n=179 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.	2.1 (g/g) STANDARD_DEVIATION 1.2 • n=358 Participants • Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.

PRIMARY outcome

Timeframe: 36 Weeks

Population: The prespecified Primary Interim Analysis was in patients who had a 24-hour UPE ≥ 2 g/day at baseline. The study was terminated after the Primary Analysis.

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants Administration of Vehicle (D5W or Saline Solution) Vehicle (D5W or saline): 5% Dextrose in water or normal saline solution	OMS721 n=70 Participants Administration of OMS721 OMS721: Biological: OMS721
Percent Change in 24-hour UPE in g/Day Compared to Baseline	-16.6 Percent Change Standard Error 0.0680	-21.3 Percent Change Standard Error 0.0672

SECONDARY outcome

Timeframe: 96 Weeks

Population: The prespecified secondary outcome analysis was in patients who had a 24-hour UPE ≥ 2 g/day at baseline. Since the study was terminated early, not all patients reached week 96, therefore the last observation was carried forward for analysis.

The Rate of Change in eGFR up to 96 Weeks from Baseline in Patients with High Baseline Proteinuria (High-risk Proteinuria Group; 24-hour UPE ≥ 2 g/Day)

Outcome measures

Outcome measures
Measure	Placebo n=111 Participants Administration of Vehicle (D5W or Saline Solution) Vehicle (D5W or saline): 5% Dextrose in water or normal saline solution	OMS721 n=112 Participants Administration of OMS721 OMS721: Biological: OMS721
Change in Annualized eGFR Compared to Baseline.	-7.9 mL/min/1.73 m²/year Standard Deviation 0.9	-8.3 mL/min/1.73 m²/year Standard Deviation 0.9

SECONDARY outcome

Timeframe: 96 Weeks

Population: The prespecified secondary outcome analysis was in patients who had a 24-hour UPE \> 1 g/day at baseline. Since the study was terminated early, not all patients reached week 96, therefore the last observation was carried forward for analysis.

The Rate of Change in eGFR up to 96 Weeks from Baseline in the All-patients Population (24-hour UPE \> 1 g/Day)

Outcome measures

Outcome measures
Measure	Placebo n=178 Participants Administration of Vehicle (D5W or Saline Solution) Vehicle (D5W or saline): 5% Dextrose in water or normal saline solution	OMS721 n=179 Participants Administration of OMS721 OMS721: Biological: OMS721
Change in Annualized eGFR Compared to Baseline in All Patients.	-7.6 mL/min/1.73 m²/year Standard Deviation 0.7	-6.4 mL/min/1.73 m²/year Standard Deviation 0.7

SECONDARY outcome

Timeframe: 36 Weeks

Population: Outcome data for this secondary outcome measure are available for a subset of 260 of the 360 participants (132 OMS721 and 128 placebo). These data are presented. Because the data collected up to the time of study termination for this outcome measure are incomplete, reliance on these measures could provide inaccurate and/or misleading information.

Change From Baseline in Log-transformed 24-hour UPE at Week 36 in the All-patients Population. (24-hour UPE \> 1 g/Day)

Outcome measures

Outcome measures
Measure	Placebo n=128 Participants Administration of Vehicle (D5W or Saline Solution) Vehicle (D5W or saline): 5% Dextrose in water or normal saline solution	OMS721 n=132 Participants Administration of OMS721 OMS721: Biological: OMS721
Change in 24-hour UPE in g/Day Compared to Baseline in All Patients	-10.3 g/ 24hrs Standard Deviation 0.6	-14.2 g/ 24hrs Standard Deviation 0.7

SECONDARY outcome

Timeframe: 36 weeks and 48 weeks

Population: Outcome measure data for this secondary outcome measure are available for a subset of 131 of the 180 participants (66 OMS721 and 65 placebo). These data are presented. Because the data collected up to the time of study termination for this outcome measure are incomplete, reliance on the data could provide inaccurate and/or misleading information.

Change From Baseline in the Log-transformed 24-hour UPE Between 36 Weeks and 48 Weeks in Patients With ≥ 2 g/Day UPE at Baseline (High-risk Proteinuria Group)

Outcome measures

Outcome measures
Measure	Placebo n=65 Participants Administration of Vehicle (D5W or Saline Solution) Vehicle (D5W or saline): 5% Dextrose in water or normal saline solution	OMS721 n=66 Participants Administration of OMS721 OMS721: Biological: OMS721
Change in 24-hour UPE in g/Day Between 36 Weeks and 48 Weeks.	4.4 g/24hr Standard Deviation 0.6	4.1 g/24hr Standard Deviation 0.5

SECONDARY outcome

Timeframe: 36 weeks and 72 weeks

Population: Outcome measure data for this secondary outcome measure are available for a subset of 121 of the 180 participants (60 OMS721 and 61 placebo). These data are presented. Because the data collected up to the time of study termination for this outcome measure are incomplete, reliance on the data could provide inaccurate and/or misleading information.

Time-averaged Change from Baseline in the Log-transformed 24-hour UPE Between 36 Weeks and 72 Weeks in Patients with ≥ 2 g/Day UPE at Baseline (High-risk Proteinuria Group)

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Administration of Vehicle (D5W or Saline Solution) Vehicle (D5W or saline): 5% Dextrose in water or normal saline solution	OMS721 n=60 Participants Administration of OMS721 OMS721: Biological: OMS721
Change in 24-hour UPE in g/Day Between 36 Weeks and 72 Weeks in Patients With >= 2 g/Day UPE at Baseline (High-risk Proteinuria Group).	7.5 g/24hr Standard Deviation 0.8	11.6 g/24hr Standard Deviation 0.7

SECONDARY outcome

Timeframe: 36 weeks and 48 weeks

Population: Outcome measure data for this secondary outcome measure are available for a subset of 229 of the 360 participants (118 OMS721 and 111 placebo). These data are presented. Because the data collected up to the time of study termination for this outcome measure are incomplete, reliance on the data could provide inaccurate and/or misleading information.

Time-averaged Change from Baseline in the Log-transformed 24-hour UPE Between 36 Weeks and 48 Weeks in the All-patients Population

Outcome measures

Outcome measures
Measure	Placebo n=111 Participants Administration of Vehicle (D5W or Saline Solution) Vehicle (D5W or saline): 5% Dextrose in water or normal saline solution	OMS721 n=118 Participants Administration of OMS721 OMS721: Biological: OMS721
Change in 24-hour UPE in g/Day Between 36 Weeks and 48 Weeks in All Patients	3.5 g/24hr Standard Deviation 0.6	6.2 g/24hr Standard Deviation 0.5

SECONDARY outcome

Timeframe: 36 weeks and 72 weeks

Population: Outcome measure data for this secondary outcome measure are available for a subset of 203 of the 360 participants (103 OMS721 and 100 placebo). These data are presented. Because the data collected up to the time of study termination for this outcome measure are incomplete, reliance on the data could provide inaccurate and/or misleading information.

Time-averaged Change from Baseline in the Log-transformed 24-hour UPE between 36 Weeks and 72 Weeks in the All-patients Population

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Administration of Vehicle (D5W or Saline Solution) Vehicle (D5W or saline): 5% Dextrose in water or normal saline solution	OMS721 n=103 Participants Administration of OMS721 OMS721: Biological: OMS721
Change in 24-hour UPE in g/Day Between 36 Weeks and 72 Weeks in All Patients	14.2 g/24hr Standard Deviation 0.8	10.9 g/24hr Standard Deviation 0.7

SECONDARY outcome

Timeframe: Week 112

Population: Any patient who received study drug (N=360)

As assessed by the incidence of adverse events through study completion (Week 112) in the patient group in the all-patients population. Clinically meaningful abnormalities in vital signs, clinical laboratory tests, and ECGs were collected as AEs.

Outcome measures

Outcome measures
Measure	Placebo n=179 Participants Administration of Vehicle (D5W or Saline Solution) Vehicle (D5W or saline): 5% Dextrose in water or normal saline solution	OMS721 n=181 Participants Administration of OMS721 OMS721: Biological: OMS721
Safety and Tolerability of Narsoplimab for the Treatment of IgAN as Assessed by AEs, Vital Signs, Clinical Laboratory Tests, and ECGs	179 Participants	181 Participants

Adverse Events

OMS721

Serious events: 22 serious events

Other events: 137 other events

Deaths: 0 deaths

Placebo

Serious events: 20 serious events

Other events: 121 other events

Deaths: 1 deaths

Open-Label OMS721

Serious events: 7 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Skylar Liles

Omeros

Phone: 206-676-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All PIs are restricted from publishing the results of the study until after sponsor publishes or 18 months after end of study at all sites. Sponsor requires removal of confidential information
Publication restrictions are in place

Restriction type: OTHER

Measure	OMS721 n=181 participants at risk Administration of OMS721 OMS721: Biological: OMS721	Placebo n=179 participants at risk Administration of Vehicle (D5W or Saline Solution) Vehicle (D5W or saline): 5% Dextrose in water or normal saline solution	Open-Label OMS721 n=34 participants at risk Subgroup of patients from blinded (either treatment group) who subsequently received open-label OMS721 during the open-label period OMS721: Biological: OMS721
Infections and infestations SAE by System Organ	3.9% 7/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	3.9% 7/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	8.8% 3/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SAE by System Organ	1.7% 3/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.56% 1/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
Blood and lymphatic system disorders SAE by System Organ	0.55% 1/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	1.1% 2/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
Immune system disorders SAE by System Organ	0.55% 1/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.56% 1/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
Metabolism and nutrition disorders SAE by System Organ	1.1% 2/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	1.7% 3/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
Nervous system disorders SAE by System Organ	1.1% 2/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
Ear and labyrinth disorders SAE by System Organ	0.00% 0/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.56% 1/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
Cardiac disorders SAE by System Organ	0.00% 0/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	1.1% 2/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
Vascular disorders SAE by System Organ	0.55% 1/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
Gastrointestinal disorders SAE by System Organ	1.7% 3/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	2.9% 1/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
Hepatobiliary disorders SAE by System Organ	0.55% 1/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
Musculoskeletal and connective tissue disorders SAE by System Organ	0.55% 1/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	1.7% 3/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
Renal and urinary disorders SAE by System Organ	5.0% 9/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	3.9% 7/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	11.8% 4/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
Pregnancy, puerperium and perinatal conditions SAE by System Organ	0.00% 0/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.56% 1/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
General disorders SAE by System Organ	0.55% 1/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	1.1% 2/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
Injury, poisoning and procedural complications SAE by System Organ	0.55% 1/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	1.7% 3/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
Product Issues SAE by System Organ	0.55% 1/181 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/179 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.	0.00% 0/34 • The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.