Trial Outcomes & Findings for Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies (NCT NCT02222545)

Last Updated: 2024-08-28

Results Overview

Incidence of treatment-emergent adverse events (AEs): clinically significant changes in vital signs, ECG, and laboratory tests were reported as AEs.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

58 participants

Primary outcome timeframe

Day 1 to 37 days after end of treatment, approximately up to 31 weeks.

Results posted on

2024-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	OMS721 Low Dose Administration of OMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose Administration of OMS721 at a high dose OMS721
Overall Study STARTED	3	3	52
Overall Study COMPLETED	2	3	27
Overall Study NOT COMPLETED	1	0	25

Reasons for withdrawal

Reasons for withdrawal
Measure	OMS721 Low Dose Administration of OMS721 at a low dose OMS721	OMS721 High Dose Administration of OMS721 at a high dose OMS721
Overall Study Adverse Event	1	2
Overall Study Death	0	9
Overall Study Deaths based on Long Term Chart Review of HSCT patients	0	10
Overall Study Withdrawal by Subject	0	3
Overall Study Proceeded to compassionate use of OMS721	0	1

Baseline Characteristics

Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OMS721 Low Dose n=3 Participants Administration of OMS721 at a low dose OMS721	OMS721 Medium Dose n=3 Participants Administration of OMS721 at a medium dose OMS721	OMS721 High Dose n=52 Participants Administration of OMS721 at a high dose OMS721	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	44 Participants n=5 Participants	48 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants
Age, Continuous	45.3 years STANDARD_DEVIATION 17.6 • n=5 Participants	31.7 years STANDARD_DEVIATION 18.7 • n=7 Participants	47.7 years STANDARD_DEVIATION 16.1 • n=5 Participants	46.7 years STANDARD_DEVIATION 16.3 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	21 Participants n=5 Participants	24 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	31 Participants n=5 Participants	34 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	50 Participants n=5 Participants	56 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	13 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	35 Participants n=5 Participants	40 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 to 37 days after end of treatment, approximately up to 31 weeks.

Population: 28 participants entered the study with a diagnosis of HSCT-TMA; all participants were in the High Dose Arm

Incidence of treatment-emergent adverse events (AEs): clinically significant changes in vital signs, ECG, and laboratory tests were reported as AEs.

Outcome measures

Outcome measures
Measure	OMS721 Low Dose Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose n=28 Participants Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA	0 Participants	0 Participants	27 Participants	—	—	—

PRIMARY outcome

Timeframe: Day 1 to up to 2 years following the first dose of OMS721

Population: Only subjects with HSCT-TMA were analyzed; 28 subjects with HSCT were in the Full Analysis Set (FAS)

Response defined as: Improvement in TMA laboratory markers of platelet count and lactate dehydrogenase (LDH) and improvement in clinical status

Outcome measures

Outcome measures
Measure	OMS721 Low Dose Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose n=28 Participants Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Number of Participants With HSCT-TMA Who Respond to OMS721	0 Participants	0 Participants	17 Participants	—	—	—

SECONDARY outcome

Timeframe: Study Day of HSCT-TMA diagnosis to 100 days later

Population: Only participants with HSCT-TMA were analyzed; all 28 HSCT-TMA participants were in the OMS721 high dose arm

Number of participants alive from the date of TMA diagnosis

Outcome measures

Outcome measures
Measure	OMS721 Low Dose Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose n=28 Participants Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Participants With HSCT-TMA Treated With OMS721: 100-day Survival	0 Participants	0 Participants	19 Participants	—	—	—

SECONDARY outcome

Timeframe: Study Day of HSCT-TMA diagnosis to up to 2 years following first dose of OMS721

Population: Only participants with HSCT-TMA were analyzed; all 28 HSCT-TMA participants were in the OMS721 high dose arm

Survival days from the day of TMA diagnosis

Outcome measures

Outcome measures
Measure	OMS721 Low Dose Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose n=28 Participants Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Participants With HSCT-TMA Treated With OMS721: Overall Survival	—	—	274 days Interval 103.0 to Upper limit of 95% CI not reached due to insufficient number of participants with events.	—	—	—

SECONDARY outcome

Timeframe: Study Day 1 to up to 2 years following first dose of OMS721

Population: Only participants with HSCT-TMA and responded to OMS721 were analyzed.

Number of days from the first response date to the first relapse date

Outcome measures

Outcome measures
Measure	OMS721 Low Dose Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose n=17 Participants Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Participants With HSCT-TMA Treated With OMS721: Duration of Response	—	—	561 Days Interval 185.0 to 757.0	—	—	—

SECONDARY outcome

Timeframe: Study Day -14 to 4 weeks following the last platelet transfusion

Population: Only participants with HSCT-TMA who were receiving platelet transfusions were analyzed; all were in the OMS721 high dose arm

Number of participants with absence of platelet transfusions

Outcome measures

Outcome measures
Measure	OMS721 Low Dose Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose n=18 Participants Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Participants With HSCT-TMA Treated With OMS721: Freedom From Platelet Transfusion	—	—	8 Participants	—	—	—

SECONDARY outcome

Timeframe: Study Day -14 to 4 weeks following the last RBC transfusion

Population: Only participants with HSCT-TMA who were receiving RBC transfusions were analyzed; all were in the OMS721 high dose arm

Number of participants with absence of RBC transfusions

Outcome measures

Outcome measures
Measure	OMS721 Low Dose Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose n=22 Participants Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Participants With HSCT-TMA Treated With OMS721: Freedom From Red Blood Cell (RBC) Transfusion	—	—	11 Participants	—	—	—

SECONDARY outcome

Timeframe: Study Day 1 to Day 97, approximately 13 weeks

Population: Only participants with HSCT-TMA were analyzed; all were in the OMS721 high dose arm

Changes from baseline in Platelet count

Outcome measures

Outcome measures
Measure	OMS721 Low Dose Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose n=28 Participants Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Platelet Count	—	—	29.5 10^9 cells per liter Interval 13.5 to 45.6	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and up to 204 days post-dose

Population: PK parameters were reported for all groups combined.

PK parameters including clearance rate

Outcome measures

Outcome measures
Measure	OMS721 Low Dose n=28 Participants Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721	0.1422 L/H Standard Deviation 0.0918	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and up to 204 days post-dose

Presence of ADA response. Immunogenicity of multiple-dose administration of OMS721 in subjects with TMA

Outcome measures

Outcome measures
Measure	OMS721 Low Dose n=28 Participants Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose n=1 Participants Administration of OMS721 at a medium dose OMS721	OMS721 High Dose n=4 Participants Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose n=3 Participants 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose n=2 Participants 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose n=20 Participants 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Participants With HSCT-TMA (ADA)	3 Participants	0 Participants	1 Participants	1 Participants	0 Participants	6 Participants

SECONDARY outcome

Timeframe: Study Day 1 to Day 97, approximately 13 weeks

Population: Only participants with HSCT-TMA were analyzed; all were in the OMS721 high dose arm

Changes from baseline in LDH

Outcome measures

Outcome measures
Measure	OMS721 Low Dose Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose n=28 Participants Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Participants With HSCT-TMA Treated With OMS721: Change From Baseline in LDH	—	—	-111.9 U/L Interval -190.7 to -33.1	—	—	—

SECONDARY outcome

Timeframe: Study Day 1 to Day 97, approximately 13 weeks

Population: Only participants with HSCT-TMA were analyzed; all were in the OMS721 high dose arm

Changes from baseline in Creatine

Outcome measures

Outcome measures
Measure	OMS721 Low Dose Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose n=28 Participants Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Creatine	—	—	-0.18 mg/dL Interval -0.43 to 0.07	—	—	—

SECONDARY outcome

Timeframe: Study Day 1 to Day 97, approximately 13 weeks

Population: Only participants with HSCT-TMA were analyzed; all were in the OMS721 high dose arm

Changes from baseline in Haptoglobin

Outcome measures

Outcome measures
Measure	OMS721 Low Dose Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose n=27 Participants Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Haptoglobin	—	—	67.7 mg/dL Interval 40.2 to 95.2	—	—	—

SECONDARY outcome

Timeframe: Study Day 1 to Day 97, approximately 13 weeks

Population: Only participants with HSCT-TMA were analyzed; all were in the OMS721 high dose arm

Changes from baseline in Hemoglobin

Outcome measures

Outcome measures
Measure	OMS721 Low Dose Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose n=22 Participants Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Hemoglobin	—	—	0.38 g/dL Interval -0.17 to 0.92	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and up to 204 days post-dose

Population: PK parameters were reported for all groups combined.

PK parameters Apparent volume of the central compartment (V1)

Outcome measures

Outcome measures
Measure	OMS721 Low Dose n=28 Participants Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721 Apparent volume of the central compartment (V1)	11.6 L Standard Deviation 3.8	—	—	—	—	—
Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721 Apparent volume of the peripheral compartment (V2)	5.6 L Standard Deviation 3.2	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and up to 204 days post-dose

Population: PK parameters were reported for all groups combined.

PK parameters Concentration of OMS721 that achieves half maximum elimination rate (KM) (ug/mL)

Outcome measures

Outcome measures
Measure	OMS721 Low Dose n=28 Participants Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721	14.2 ug/mL Standard Deviation 15.2	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and up to 204 days post-dose

Population: PD was analyzed only in HSCT-TMA participants

PD measure is expressed as percentage inhibition of C4d to assess ex-vivo lectin pathway activation

Outcome measures

Outcome measures
Measure	OMS721 Low Dose n=28 Participants Administration ofOMS721 at a low dose OMS721	OMS721 Medium Dose Administration of OMS721 at a medium dose OMS721	OMS721 High Dose Administration of OMS721 at a high dose OMS721	OMS721-TMA-001 aHUS Low Dose 3 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS Medium Dose 2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS	OMS721-TMA-001 aHUS High Dose 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS
Participants With HSCT-TMA: Pharmacodynamics (PD) Baseline inhibition ex vivo lectin-mediated C4d Formation %	26.3 Percentage Standard Deviation 31.8	—	—	—	—	—
Participants With HSCT-TMA: Pharmacodynamics (PD) Maximum inhibition ex vivo lectin-mediated Cd4 Formation %	95.9 Percentage Standard Deviation 1.21	—	—	—	—	—

Adverse Events

HSCT-TMA-001 High Dose (N=28)

Serious events: 17 serious events

Other events: 27 other events

Deaths: 16 deaths

aHUS OMS721-TMA-001 Low Dose

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

aHUS OMS721-TMA-001 Medium Dose

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

aHUS OMS721-TMA-001 High Dose

Serious events: 12 serious events

Other events: 19 other events

Deaths: 3 deaths

TTP OMS721-TMA-001 Medium Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TTP OMS721-TMA-001 High Dose

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HSCT-TMA-001 High Dose (N=28) n=28 participants at risk 28 participants entered the study with a diagnosis of HSCT-TMA	aHUS OMS721-TMA-001 Low Dose n=3 participants at risk Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term reported for 3 patients with aHUS	aHUS OMS721-TMA-001 Medium Dose n=2 participants at risk Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term reported for 2 patients with aHUS	aHUS OMS721-TMA-001 High Dose n=20 participants at risk Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term reported for 20 patients with aHUS	TTP OMS721-TMA-001 Medium Dose n=1 participants at risk Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term reported by 1 patients with TTP	TTP OMS721-TMA-001 High Dose n=4 participants at risk Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term reported by 4 patients with TTP
Infections and infestations SAE by System Organ	35.7% 10/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	33.3% 1/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	35.0% 7/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Blood and lymphatic system disorders SAE by System Organ	10.7% 3/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	15.0% 3/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	50.0% 2/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SAE by System Organ	7.1% 2/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Immune system disorders SAE by System Organ	17.9% 5/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	5.0% 1/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Metabolism and nutrition disorders SAE by System Organ	3.6% 1/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Psychiatric disorders SAE by System Organ	10.7% 3/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	5.0% 1/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Nervous system disorders SAE by System Organ	7.1% 2/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	20.0% 4/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Cardiac disorders SAE by System Organ	3.6% 1/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Vascular disorders SAE by System Organ	3.6% 1/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	15.0% 3/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Gastrointestinal disorders SAE by System Organ	10.7% 3/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	5.0% 1/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Hepatobiliary disorders SAE by System Organ	0.00% 0/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	5.0% 1/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Renal and urinary disorders SAE by System Organ	10.7% 3/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	5.0% 1/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
General disorders SAE by System Organ	7.1% 2/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	66.7% 2/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	5.0% 1/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Injury, poisoning and procedural complications SAE by System Organ	0.00% 0/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	5.0% 1/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Musculoskeletal and connective tissue disorders SAE by System Organ	3.6% 1/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Respiratory, thoracic and mediastinal disorders SAE by System Organ	17.9% 5/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.

Other adverse events

Other adverse events
Measure	HSCT-TMA-001 High Dose (N=28) n=28 participants at risk 28 participants entered the study with a diagnosis of HSCT-TMA	aHUS OMS721-TMA-001 Low Dose n=3 participants at risk Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term reported for 3 patients with aHUS	aHUS OMS721-TMA-001 Medium Dose n=2 participants at risk Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term reported for 2 patients with aHUS	aHUS OMS721-TMA-001 High Dose n=20 participants at risk Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term reported for 20 patients with aHUS	TTP OMS721-TMA-001 Medium Dose n=1 participants at risk Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term reported by 1 patients with TTP	TTP OMS721-TMA-001 High Dose n=4 participants at risk Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term reported by 4 patients with TTP
Infections and infestations AE by System Organ	71.4% 20/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	66.7% 2/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	70.0% 14/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	25.0% 1/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) AE by System Organ	10.7% 3/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	5.0% 1/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Blood and lymphatic system disorders AE by System Organ	46.4% 13/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	35.0% 7/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	50.0% 2/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Immune system disorders AE by System Organ	35.7% 10/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	5.0% 1/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	25.0% 1/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Endocrine disorders AE by System Organ	7.1% 2/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Metabolism and nutrition disorders AE by System Organ	57.1% 16/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	20.0% 4/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Psychiatric disorders AE by System Organ	21.4% 6/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	5.0% 1/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Nervous system disorders AE by System Organ	35.7% 10/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	25.0% 5/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	50.0% 2/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Eye disorders AE by System Organ	7.1% 2/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	33.3% 1/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	5.0% 1/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	25.0% 1/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Cardiac disorders AE by System Organ	25.0% 7/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	15.0% 3/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Vascular disorders AE by System Organ	28.6% 8/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	50.0% 1/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	40.0% 8/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Respiratory, thoracic and mediastinal disorders AE by System Organ	46.4% 13/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	5.0% 1/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	25.0% 1/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Gastrointestinal disorders AE by System Organ	64.3% 18/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Hepatobiliary disorders AE by System Organ	10.7% 3/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	5.0% 1/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Skin and subcutaneous tissue disorders AE by System Organ	35.7% 10/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	20.0% 4/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Musculoskeletal and connective tissue disorders AE by System Organ	42.9% 12/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	15.0% 3/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Renal and urinary disorders AE by System Organ	21.4% 6/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	33.3% 1/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	5.0% 1/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
General disorders AE by System Organ	64.3% 18/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	66.7% 2/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	25.0% 5/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Investigations AE by System Organ	35.7% 10/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	33.3% 1/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	15.0% 3/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Injury, poisoning and procedural complications AE by System Organ	21.4% 6/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	33.3% 1/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	15.0% 3/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Surgical and medical procedures AE by System Organ	0.00% 0/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	50.0% 1/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Reproductive system and breast disorders AE by System Organ	0.00% 0/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	5.0% 1/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.
Ear and labyrinth disorders AE by System Organ	0.00% 0/28 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/3 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/2 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	5.0% 1/20 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/1 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.	0.00% 0/4 • The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug. AEs are assessed throughout the study up to 2 years.

Additional Information

Clinical Trial Manager

Omeros Corporation

Phone: (206) 676-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place