Trial Outcomes & Findings for An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc) (NCT NCT05626751)

Last Updated: 2026-01-05

Results Overview

FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible, as measured by spirometry. FVC is a measure of respiratory function. FVC% predicted was calculated by taking the observed FVC measurement and dividing it by a predicted value multiplied by 100 (% FVC predicted = (FVC observed/FVC predicted) x 100). The predicted value is an average of the normal FVC volume for a person of the same sex, ethnicity, age and height.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

174 participants

Primary outcome timeframe

Baseline and Week 52

Results posted on

2026-01-05

Participant Flow

Participants were enrolled at 77 research centers in Argentina, Austria, Chile, France, Germany, Greece, Israel, Italy, Japan, South Korea, Mexico, Poland, Portugal, Romania, Serbia, Spain, Switzerland, the United Kingdom, and the United States between November 2022 to February 2025.

This trial is an open-label extension (OLE) of the parent trial HZNP-HZN-825-301, in which participants received either HZN-825 300 mg twice daily (BID), HZN-825 300 mg once daily (QD), or placebo. Participants in this OLE trial all received the same dose regimen: open-label HZN-825 300 mg BID, orally, for 52 weeks. Participants are analyzed according to the group determined by the treatment received in the parent trial.

Participant milestones

Participant milestones
Measure	HZN-825 300 mg QD in Parent Trial Participants who received HZN-825 300 mg QD in the parent trial received HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	HZN-825 300 mg BID in Parent Trial Participants who received HZN-825 300 mg BID in parent trial continued to receive HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	Placebo in Parent Trial Participants who received Placebo in parent trial received HZN-825 300 mg orally BID in this OLE extension for 52 weeks.
Overall Study STARTED	62	52	60
Overall Study Full Analysis Set	62	52	60
Overall Study Safety Analysis Set	62	53	59
Overall Study COMPLETED	15	15	17
Overall Study NOT COMPLETED	47	37	43

Reasons for withdrawal

Reasons for withdrawal
Measure	HZN-825 300 mg QD in Parent Trial Participants who received HZN-825 300 mg QD in the parent trial received HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	HZN-825 300 mg BID in Parent Trial Participants who received HZN-825 300 mg BID in parent trial continued to receive HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	Placebo in Parent Trial Participants who received Placebo in parent trial received HZN-825 300 mg orally BID in this OLE extension for 52 weeks.
Overall Study Lost to Follow-up	1	2	1
Overall Study Trial Terminated by Sponsor	39	30	37
Overall Study Withdrawal by Subject	7	5	5

Baseline Characteristics

An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HZN-825 300 mg QD in Parent Trial n=62 Participants Participants who received HZN-825 300 mg QD in the parent trial received HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	HZN-825 300 mg BID in Parent Trial n=52 Participants Participants who received HZN-825 300 mg BID in parent trial continued to receive HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	Placebo in Parent Trial n=60 Participants Participants who received Placebo in parent trial received HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	Total n=174 Participants Total of all reporting groups
Age, Continuous	48.9 years STANDARD_DEVIATION 12.7 • n=9667 Participants	49.8 years STANDARD_DEVIATION 11.2 • n=6597 Participants	48.5 years STANDARD_DEVIATION 12.4 • n=16264 Participants	49.0 years STANDARD_DEVIATION 12.1 • n=31 Participants
Sex: Female, Male Female	46 Participants n=9667 Participants	44 Participants n=6597 Participants	50 Participants n=16264 Participants	140 Participants n=31 Participants
Sex: Female, Male Male	16 Participants n=9667 Participants	8 Participants n=6597 Participants	10 Participants n=16264 Participants	34 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=9667 Participants	20 Participants n=6597 Participants	25 Participants n=16264 Participants	71 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=9667 Participants	32 Participants n=6597 Participants	35 Participants n=16264 Participants	103 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants	0 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9667 Participants	1 Participants n=6597 Participants	1 Participants n=16264 Participants	2 Participants n=31 Participants
Race (NIH/OMB) Asian	5 Participants n=9667 Participants	7 Participants n=6597 Participants	9 Participants n=16264 Participants	21 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9667 Participants	1 Participants n=6597 Participants	1 Participants n=16264 Participants	2 Participants n=31 Participants
Race (NIH/OMB) Black or African American	2 Participants n=9667 Participants	1 Participants n=6597 Participants	2 Participants n=16264 Participants	5 Participants n=31 Participants
Race (NIH/OMB) White	54 Participants n=9667 Participants	36 Participants n=6597 Participants	44 Participants n=16264 Participants	134 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=9667 Participants	6 Participants n=6597 Participants	3 Participants n=16264 Participants	10 Participants n=31 Participants

PRIMARY outcome

Timeframe: Baseline and Week 52

Population: The FAS included all participants who were enrolled and received at least one full or partial dose of HZN-825 in this extension trial. Only participants with available data were included in this endpoint. Participants were analyzed according to the group determined by the treatment that the participant received in the parent trial HZNP-HZN-825-301.

Outcome measures

Outcome measures
Measure	HZN-825 300 mg QD in Parent Trial n=14 Participants Participants who received HZN-825 300 mg QD in the parent trial received HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	HZN-825 300 mg BID in Parent Trial n=15 Participants Participants who received HZN-825 300 mg BID in parent trial continued to receive HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	Placebo in Parent Trial n=13 Participants Participants who received Placebo in parent trial received HZN-825 300 mg orally BID in this OLE extension for 52 weeks.
Change From Baseline in Forced Vital Capacity Percentage (FVC%) Predicted at Week 52	-1.36 % predicted FVC Standard Deviation 8.46	-7.95 % predicted FVC Standard Deviation 15.36	-0.82 % predicted FVC Standard Deviation 4.09

PRIMARY outcome

Timeframe: From 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months

Population: The safety analysis set (SAS) included all participants who had received at least one dose or partial dose of HZN-825 in the extension trial.

An adverse event (AE) was defined as any untoward medical occurrence in a trial participant who received an investigational product (IP), regardless of a causal relationship with treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of an IP. TEAEs were defined as events that began or worsened in severity on or after the first dose of treatment through 28 days after the last dose or the cutoff date for ongoing participants. Serious TEAEs were those that resulted in death, were life-threatening, required or prolonged hospitalization, caused significant disability/incapacity, led to a congenital anomaly/birth defect, or were considered other important medical events. Clinically significant changes in vital signs, electrocardiograms (ECGs), and laboratory tests were included as TEAEs.

Outcome measures

Outcome measures
Measure	HZN-825 300 mg QD in Parent Trial n=62 Participants Participants who received HZN-825 300 mg QD in the parent trial received HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	HZN-825 300 mg BID in Parent Trial n=53 Participants Participants who received HZN-825 300 mg BID in parent trial continued to receive HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	Placebo in Parent Trial n=59 Participants Participants who received Placebo in parent trial received HZN-825 300 mg orally BID in this OLE extension for 52 weeks.
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs TEAEs	34 Participants	37 Participants	35 Participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs Serious TEAEs	2 Participants	2 Participants	5 Participants

PRIMARY outcome

Timeframe: Day 1 and at Weeks 4, 28 and 52

Population: The SAS included all participants who had received at least one dose or partial dose of HZN-825 in the extension trial.

The following AESI was identified for this trial: Orthostatic hypotension defined as a reduction of systolic blood pressure by ≥20 mmHg or reduction of diastolic blood pressure by ≥10 mmHg and associated with symptoms such as lightheadedness, blurred vision, weakness, fatigue, cognitive impairment, nausea, palpitations, tremulousness, headache, presyncope or syncope.

Outcome measures

Outcome measures
Measure	HZN-825 300 mg QD in Parent Trial n=62 Participants Participants who received HZN-825 300 mg QD in the parent trial received HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	HZN-825 300 mg BID in Parent Trial n=53 Participants Participants who received HZN-825 300 mg BID in parent trial continued to receive HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	Placebo in Parent Trial n=59 Participants Participants who received Placebo in parent trial received HZN-825 300 mg orally BID in this OLE extension for 52 weeks.
Number of Participants Who Experienced AEs of Special Interest (AESI)	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months

Population: The SAS included all participants who had received at least one dose or partial dose of HZN-825 in the extension trial.

Concomitant medications were defined as any medication that was ongoing, had a start date on or after the first dose of the trial drug, or had a stop date on or after the first dose date.

Outcome measures

Outcome measures
Measure	HZN-825 300 mg QD in Parent Trial n=62 Participants Participants who received HZN-825 300 mg QD in the parent trial received HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	HZN-825 300 mg BID in Parent Trial n=53 Participants Participants who received HZN-825 300 mg BID in parent trial continued to receive HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	Placebo in Parent Trial n=59 Participants Participants who received Placebo in parent trial received HZN-825 300 mg orally BID in this OLE extension for 52 weeks.
Number of Participants Using Any Concomitant Medication	62 Participants	52 Participants	58 Participants

Adverse Events

HZN-825 300 mg QD in Parent Trial

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

HZN-825 300 mg BID in Parent Trial

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo in Parent Trial

Serious events: 5 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	HZN-825 300 mg QD in Parent Trial n=62 participants at risk Participants who received HZN-825 300 mg QD in the parent trial received HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	HZN-825 300 mg BID in Parent Trial n=53 participants at risk Participants who received HZN-825 300 mg BID in parent trial continued to receive HZN-825 300 mg orally BID in this OLE extension for 52 weeks.	Placebo in Parent Trial n=59 participants at risk Participants who received Placebo in parent trial received HZN-825 300 mg orally BID in this OLE extension for 52 weeks.
Gastrointestinal disorders Diarrhoea	4.8% 3/62 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	1.9% 1/53 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	8.5% 5/59 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.
Gastrointestinal disorders Dyspepsia	0.00% 0/62 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	0.00% 0/53 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	6.8% 4/59 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.
Gastrointestinal disorders Gastrooesophageal reflux disease	3.2% 2/62 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	3.8% 2/53 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	5.1% 3/59 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.
Gastrointestinal disorders Nausea	1.6% 1/62 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	1.9% 1/53 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	5.1% 3/59 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.
Gastrointestinal disorders Vomiting	4.8% 3/62 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	5.7% 3/53 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	0.00% 0/59 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.
Infections and infestations COVID-19	4.8% 3/62 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	7.5% 4/53 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	3.4% 2/59 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.
Infections and infestations Nasopharyngitis	4.8% 3/62 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	7.5% 4/53 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	8.5% 5/59 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.
Infections and infestations Pharyngitis	0.00% 0/62 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	5.7% 3/53 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	0.00% 0/59 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.
Infections and infestations Urinary tract infection	4.8% 3/62 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	5.7% 3/53 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	5.1% 3/59 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.
Musculoskeletal and connective tissue disorders Arthralgia	3.2% 2/62 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	7.5% 4/53 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	1.7% 1/59 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.
Skin and subcutaneous tissue disorders Skin ulcer	4.8% 3/62 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	0.00% 0/53 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	5.1% 3/59 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.
Vascular disorders Hypotension	6.5% 4/62 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	0.00% 0/53 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.	0.00% 0/59 • All-cause mortality: from enrollment to end of trial; median (min, max) time on trial 9.0 (0.8, 15.2) months. AEs: from 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months. All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER