Trial Outcomes & Findings for Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation (NCT NCT04755283)

Last Updated: 2025-11-06

Results Overview

The number of participants experiencing the first occurrence of the composite of ISTH-defined major bleeding or CRNM bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

1287 participants

Primary outcome timeframe

Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.

Results posted on

2025-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Abelacimab 90 mg (MAA868) Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)	Abelacimab 150 mg (MAA868) Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)	Rivaroxaban Treatment group 3: Rivaroxaban 20 mg by mouth; orally (p.o.) once per day with the evening meal Participants with a Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation will have a dose adaptation to rivaroxaban 15 mg p.o. daily. Rivaroxaban: Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets
Overall Study STARTED	427	430	430
Overall Study Entered Open-Label	250	240	215
Overall Study COMPLETED	382	391	389
Overall Study NOT COMPLETED	45	39	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Abelacimab 90 mg (MAA868) Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)	Abelacimab 150 mg (MAA868) Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)	Rivaroxaban Treatment group 3: Rivaroxaban 20 mg by mouth; orally (p.o.) once per day with the evening meal Participants with a Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation will have a dose adaptation to rivaroxaban 15 mg p.o. daily. Rivaroxaban: Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets
Overall Study Withdrawal by Subject	14	3	6
Overall Study Lost to Follow-up	0	0	1
Overall Study Death	31	36	34

Baseline Characteristics

The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abelacimab 90 mg (MAA868) n=427 Participants Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)	Abelacimab 150 mg (MAA868) n=430 Participants Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)	Rivaroxaban n=430 Participants Treatment group 3: Rivaroxaban 20 mg by mouth; orally (p.o.) once per day with the evening meal Participants with a Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation will have a dose adaptation to rivaroxaban 15 mg p.o. daily. Rivaroxaban: Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets	Total n=1287 Participants Total of all reporting groups
Age, Customized ≥ 80 years	87 Participants n=427 Participants	81 Participants n=430 Participants	90 Participants n=430 Participants	258 Participants n=1287 Participants
Sex/Gender, Customized Female sex	195 Participants n=427 Participants	193 Participants n=430 Participants	184 Participants n=430 Participants	572 Participants n=1287 Participants
Race/Ethnicity, Customized White	404 Participants n=427 Participants	410 Participants n=430 Participants	404 Participants n=430 Participants	1218 Participants n=1287 Participants
Race/Ethnicity, Customized Asian	20 Participants n=427 Participants	15 Participants n=430 Participants	24 Participants n=430 Participants	59 Participants n=1287 Participants
Race/Ethnicity, Customized Black	3 Participants n=427 Participants	5 Participants n=430 Participants	2 Participants n=430 Participants	10 Participants n=1287 Participants
Median Age	75 years n=427 Participants	74 years n=430 Participants	74 years n=430 Participants	74 years n=1287 Participants
Region of Enrollment North America	126 Participants n=427 Participants	106 Participants n=430 Participants	103 Participants n=430 Participants	335 Participants n=1287 Participants
Region of Enrollment Europe	282 Participants n=427 Participants	309 Participants n=430 Participants	305 Participants n=430 Participants	896 Participants n=1287 Participants
Region of Enrollment Asia	19 Participants n=427 Participants	15 Participants n=430 Participants	22 Participants n=430 Participants	56 Participants n=1287 Participants
Median body-mass index (IQR)	29.5 kg/m² n=427 Participants	30.0 kg/m² n=430 Participants	30.3 kg/m² n=430 Participants	29.9 kg/m² n=1287 Participants
Creatinine clearance ≤50 ml/min	86 Participants n=425 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	90 Participants n=430 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	88 Participants n=429 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	264 Participants n=1284 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.
Pattern of atrial fibrillation First detected or paroxysmal	224 Participants n=426 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	220 Participants n=424 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	225 Participants n=428 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	669 Participants n=1278 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.
Pattern of atrial fibrillation Persistent or long-standing persistent	87 Participants n=426 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	84 Participants n=424 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	97 Participants n=428 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	268 Participants n=1278 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.
Pattern of atrial fibrillation Permanent	115 Participants n=426 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	120 Participants n=424 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	106 Participants n=428 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	341 Participants n=1278 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.
Median CHA₂DS₂-VASc score	5.0 score n=427 Participants	5.0 score n=430 Participants	5.0 score n=430 Participants	5.0 score n=1287 Participants
CHA₂DS₂-VASc score ≤4	191 Participants n=427 Participants	213 Participants n=430 Participants	186 Participants n=430 Participants	590 Participants n=1287 Participants
CHA₂DS₂-VASc score 5	135 Participants n=427 Participants	131 Participants n=430 Participants	130 Participants n=430 Participants	396 Participants n=1287 Participants
CHA₂DS₂-VASc score ≥6	101 Participants n=427 Participants	86 Participants n=430 Participants	114 Participants n=430 Participants	301 Participants n=1287 Participants
Median HAS-BLED score	2.0 score n=427 Participants	2.0 score n=430 Participants	3.0 score n=430 Participants	3.0 score n=1287 Participants
HAS-BLED score ≥3	210 Participants n=427 Participants	213 Participants n=430 Participants	225 Participants n=430 Participants	648 Participants n=1287 Participants
Hypertension	410 Participants n=427 Participants	417 Participants n=430 Participants	418 Participants n=430 Participants	1245 Participants n=1287 Participants
Diabetes	223 Participants n=427 Participants	231 Participants n=430 Participants	245 Participants n=430 Participants	699 Participants n=1287 Participants
Heart failure	192 Participants n=427 Participants	182 Participants n=430 Participants	206 Participants n=430 Participants	580 Participants n=1287 Participants
Coronary artery disease	218 Participants n=427 Participants	199 Participants n=430 Participants	205 Participants n=430 Participants	622 Participants n=1287 Participants
Previous ischemic stroke	57 Participants n=427 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	59 Participants n=430 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	75 Participants n=429 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	191 Participants n=1286 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.
Previous transient ischemic attack	38 Participants n=426 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	25 Participants n=429 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	32 Participants n=429 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	95 Participants n=1284 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.
History of bleeding Any bleeding	29 Participants n=424 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	34 Participants n=425 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	36 Participants n=427 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	99 Participants n=1276 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.
History of bleeding Gastrointestinal bleeding	16 Participants n=427 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	22 Participants n=428 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	23 Participants n=428 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	61 Participants n=1283 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.
Planned concomitant antiplatelet medication Aspirin	72 Participants n=107 Participants • The number of participants with planned concomitant antiplatelet medication are presented.	70 Participants n=105 Participants • The number of participants with planned concomitant antiplatelet medication are presented.	58 Participants n=106 Participants • The number of participants with planned concomitant antiplatelet medication are presented.	200 Participants n=318 Participants • The number of participants with planned concomitant antiplatelet medication are presented.
Anticoagulation ≥60 days Anticoagulation ≥60 days	389 Participants n=426 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	389 Participants n=430 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	404 Participants n=430 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	1182 Participants n=1286 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.
Anticoagulation ≥60 days Vitamin K antagonist	125 Participants n=426 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	130 Participants n=430 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	130 Participants n=430 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	385 Participants n=1286 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.
Anticoagulation ≥60 days Direct oral anticoagulant	283 Participants n=426 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	271 Participants n=430 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	291 Participants n=430 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	845 Participants n=1286 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.
Anticoagulation ≥60 days Parenteral agent	3 Participants n=426 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	9 Participants n=430 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	6 Participants n=430 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	18 Participants n=1286 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.
Anticoagulation ≥60 days Previous use of >1 anticoagulant	22 Participants n=426 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	21 Participants n=430 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	23 Participants n=430 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.	66 Participants n=1286 Participants • The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.
Planned concomitant antiplatelet medication P2Y12 inhibitor	26 Participants n=107 Participants • The number of participants with planned concomitant antiplatelet medication are presented.	29 Participants n=105 Participants • The number of participants with planned concomitant antiplatelet medication are presented.	42 Participants n=106 Participants • The number of participants with planned concomitant antiplatelet medication are presented.	97 Participants n=318 Participants • The number of participants with planned concomitant antiplatelet medication are presented.
Planned concomitant antiplatelet medication Dual antiplatelet therapy	9 Participants n=107 Participants • The number of participants with planned concomitant antiplatelet medication are presented.	6 Participants n=105 Participants • The number of participants with planned concomitant antiplatelet medication are presented.	6 Participants n=106 Participants • The number of participants with planned concomitant antiplatelet medication are presented.	21 Participants n=318 Participants • The number of participants with planned concomitant antiplatelet medication are presented.

PRIMARY outcome

Timeframe: Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.

Population: The analysis population is the number of randomized participants who received at least one dose of study treatment. The difference between the overall number of participants analyzed and the overall number of participants assigned to the arm represents those who never received a dose of study treatment.

Outcome measures

Outcome measures
Measure	Abelacimab 90 mg (MAA868) n=425 Participants Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)	Abelacimab 150 mg (MAA868) n=427 Participants Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)	Rivaroxaban n=428 Participants Treatment group 3: Rivaroxaban 20 mg by mouth; orally (p.o.) once per day with the evening meal Participants with a Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation will have a dose adaptation to rivaroxaban 15 mg p.o. daily. Rivaroxaban: Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets
Incidence Rate of the First Occurrence of Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major Bleeding or Clinically Relevant Non-Major (CRNM) Bleeding Events	2.64 participants with event/100 person-years	3.22 participants with event/100 person-years	8.39 participants with event/100 person-years

SECONDARY outcome

Timeframe: Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.

The number of participants experiencing the first occurrence of ISTH-defined major bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase.

Outcome measures

Outcome measures
Measure	Abelacimab 90 mg (MAA868) n=425 Participants Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)	Abelacimab 150 mg (MAA868) n=427 Participants Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)	Rivaroxaban n=428 Participants Treatment group 3: Rivaroxaban 20 mg by mouth; orally (p.o.) once per day with the evening meal Participants with a Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation will have a dose adaptation to rivaroxaban 15 mg p.o. daily. Rivaroxaban: Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets
Incidence Rate of the First Occurrence of ISTH-defined Major Bleeding Events	0.99 participants with event/100 person-years	1.22 participants with event/100 person-years	3.73 participants with event/100 person-years

SECONDARY outcome

Timeframe: Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.

The number of participants experiencing the first occurrence of the composite of ISTH-defined major or CRNM or minor bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase.

Outcome measures

Outcome measures
Measure	Abelacimab 90 mg (MAA868) n=425 Participants Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)	Abelacimab 150 mg (MAA868) n=427 Participants Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)	Rivaroxaban n=428 Participants Treatment group 3: Rivaroxaban 20 mg by mouth; orally (p.o.) once per day with the evening meal Participants with a Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation will have a dose adaptation to rivaroxaban 15 mg p.o. daily. Rivaroxaban: Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets
Incidence Rate of the First Occurrence of ISTH-defined Major or CRNM or Minor Bleeding Events	7.05 participants with event/100 person-years	10.43 participants with event/100 person-years	15.30 participants with event/100 person-years

Adverse Events

Abelacimab 90 mg (MAA868)

Serious events: 158 serious events

Other events: 215 other events

Deaths: 31 deaths

Abelacimab 150 mg (MAA868)

Serious events: 157 serious events

Other events: 257 other events

Deaths: 36 deaths

Rivaroxaban

Serious events: 167 serious events

Other events: 227 other events

Deaths: 34 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Abelacimab 90 mg (MAA868) n=425 participants at risk Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)	Abelacimab 150 mg (MAA868) n=427 participants at risk Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)	Rivaroxaban n=428 participants at risk Treatment group 3: Rivaroxaban 20 mg by mouth; orally (p.o.) once per day with the evening meal Participants with a Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation will have a dose adaptation to rivaroxaban 15 mg p.o. daily. Rivaroxaban: Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets
Infections and infestations COVID-19	9.6% 41/425 • Number of events 42 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	11.2% 48/427 • Number of events 49 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	10.5% 45/428 • Number of events 46 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.
Cardiac disorders Atrial fibrillation	6.6% 28/425 • Number of events 39 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	6.3% 27/427 • Number of events 34 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	5.6% 24/428 • Number of events 31 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.
Musculoskeletal and connective tissue disorders Arthralgia	5.4% 23/425 • Number of events 26 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	6.1% 26/427 • Number of events 31 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	6.3% 27/428 • Number of events 29 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.
Vascular disorders Hypertension	5.6% 24/425 • Number of events 25 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	6.1% 26/427 • Number of events 27 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	4.7% 20/428 • Number of events 22 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.
Musculoskeletal and connective tissue disorders Back pain	4.7% 20/425 • Number of events 21 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	6.1% 26/427 • Number of events 29 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	5.1% 22/428 • Number of events 24 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.
Infections and infestations Urinary tract infection	6.4% 27/425 • Number of events 38 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	5.6% 24/427 • Number of events 27 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	2.8% 12/428 • Number of events 12 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.
Blood and lymphatic system disorders Anaemia	4.2% 18/425 • Number of events 23 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	4.0% 17/427 • Number of events 18 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	5.6% 24/428 • Number of events 29 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.
Injury, poisoning and procedural complications Contusion	2.4% 10/425 • Number of events 15 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	6.3% 27/427 • Number of events 36 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	3.5% 15/428 • Number of events 19 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.
Nervous system disorders Headache	3.1% 13/425 • Number of events 15 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	6.3% 27/427 • Number of events 33 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	2.6% 11/428 • Number of events 14 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.6% 11/425 • Number of events 14 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	2.1% 9/427 • Number of events 12 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.	6.3% 27/428 • Number of events 41 • Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months). The appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting study drug even if event is not considered to be related to study drug is considered an AE. Reports of intentional misuse and abuse of study treatment are considered AEs, even without a clinical event. AEs may be detected by non-directive questioning, voluntary reports, or findings from exams, lab tests, or other assessments. AEs are presented for the Analysis Population.

Additional Information

Study Director

Anthos Therapeutics, a Novartis company

Phone: +1-888-669-6682

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No publication by Institution or Investigator until after publication of the results by Sponsor. If there is no multicenter publication within 18 months after the end of the Study, Institution and Investigator may publish if Sponsor is given the opportunity to review at least 45 days prior to submission for publication. Sponsor may remove any Information other than Study Data from a proposed publication. Sponsor may defer publication or other disclosure for a period of 60 additional days.
Publication restrictions are in place

Restriction type: OTHER