Trial Outcomes & Findings for A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis (NCT NCT04594707)

Results Overview

An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product, regardless of causal attribution. Grading was completed according to the CTCAE, version 5.0.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

117 participants

Primary outcome timeframe

From baseline until 8 weeks after the final dose, an average of 6 months

Results posted on

2024-05-16

Participant Flow

Participants were enrolled across 48 investigative sites in 16 countries.

Participant milestones

Participant milestones
Measure	Cohort A: Zinpentraxin Alfa Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa Participants entered, following participation in study WA42293.
Overall Study STARTED	21	49	47
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	21	49	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A: Zinpentraxin Alfa Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa Participants entered, following participation in study WA42293.
Overall Study Adverse Event	0	0	1
Overall Study Death	0	2	2
Overall Study Lung Transplant	0	0	1
Overall Study Grade 4 infusion related reaction (IRR)	1	0	0
Overall Study Study Terminated By Sponsor	19	47	41
Overall Study Withdrawal by Subject	1	0	2

Baseline Characteristics

A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A: Zinpentraxin Alfa n=21 Participants Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo n=49 Participants Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa n=47 Participants Participants entered, following participation in study WA42293.	Total n=117 Participants Total of all reporting groups
Age, Continuous	74.5 Years STANDARD_DEVIATION 5.5 • n=5 Participants	74.6 Years STANDARD_DEVIATION 7.6 • n=7 Participants	73.2 Years STANDARD_DEVIATION 6.8 • n=5 Participants	74.0 Years STANDARD_DEVIATION 6.9 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	25 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	39 Participants n=7 Participants	37 Participants n=5 Participants	92 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	47 Participants n=7 Participants	45 Participants n=5 Participants	110 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	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	47 Participants n=7 Participants	43 Participants n=5 Participants	109 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: From baseline until 8 weeks after the final dose, an average of 6 months

Population: The safety-evaluable population included all enrolled participants who received at least one administration (full or partial dose) of study drug.

An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product, regardless of causal attribution. Grading was completed according to the CTCAE, version 5.0.

Outcome measures

Outcome measures
Measure	Cohort A: Zinpentraxin Alfa n=21 Participants Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo n=49 Participants Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa n=47 Participants Participants entered, following participation in study WA42293.
Percentage of Participants With Adverse Events (AEs)	18 Participants	25 Participants	26 Participants

PRIMARY outcome

Timeframe: From baseline until 8 weeks after the final dose, an average of 6 months

Population: The safety-evaluable population included all enrolled participants who received at least one administration (full or partial dose) of study drug.

IRRs were defined as AEs that occurred during or within 24 hours after study drug administration and were judged to be related to study drug infusion.

Outcome measures

Outcome measures
Measure	Cohort A: Zinpentraxin Alfa n=21 Participants Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo n=49 Participants Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa n=47 Participants Participants entered, following participation in study WA42293.
Percentage of Participants With Infusion Related Reactions (IRRs) and Other AEs of Special Interest	2 Participants	2 Participants	4 Participants

PRIMARY outcome

Timeframe: From baseline until 8 weeks after the final dose, an average of 6 months

Population: The safety-evaluable population included all enrolled participants who received at least one administration (full or partial dose) of study drug.

Outcome measures

Outcome measures
Measure	Cohort A: Zinpentraxin Alfa n=21 Participants Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo n=49 Participants Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa n=47 Participants Participants entered, following participation in study WA42293.
Percentage of of Participants Permanently Discontinuing Study Treatment Due to AEs	2 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: From baseline until study completion (up to approximately 1.5 years)

Population: The full analysis set included all enrolled participants who received at least one administration (full or partial dose) of study drug.

Outcome measures

Outcome measures
Measure	Cohort A: Zinpentraxin Alfa n=21 Participants Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo n=49 Participants Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa n=47 Participants Participants entered, following participation in study WA42293.
Annual Rate of Change in Forced Vital Capacity (FVC) (mL)	-229.12 Milliliter (mL) Interval -317.39 to -140.9	-272.96 Milliliter (mL) Interval -698.97 to 153.06	-120.77 Milliliter (mL) Interval -546.26 to 294.73

SECONDARY outcome

Timeframe: From baseline until study completion (up to approximately 1.5 years)

Population: The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization.

Outcome measures

Outcome measures
Measure	Cohort A: Zinpentraxin Alfa n=21 Participants Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo n=49 Participants Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa n=47 Participants Participants entered, following participation in study WA42293.
Annual Rate of Change in 6-Minute Walk Distance (6MWD)	-86.95 Meters (m) Interval -170.8 to -3.1	64.64 Meters (m) Interval -98.62 to 227.9	-163.66 Meters (m) Interval -324.02 to -3.3

SECONDARY outcome

Timeframe: From baseline until study completion (up to approximately 1.5 years)

Population: The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization.

Outcome measures

Outcome measures
Measure	Cohort A: Zinpentraxin Alfa n=21 Participants Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo n=49 Participants Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa n=47 Participants Participants entered, following participation in study WA42293.
Annual Rate of Change in FVC% Predicted	-6.96 Percent predicted Interval -9.7 to -4.22	-6.91 Percent predicted Interval -14.77 to 0.96	-3.37 Percent predicted Interval -11.18 to 4.44

SECONDARY outcome

Timeframe: At Baseline, Week 24 and Week 48

Population: The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization. In the Ex-placebo arm, no participant was assessed for DLCO after baseline. Due to short length of follow-up, no DLCO assessment was collected at Week 48 for Cohort B: Zinpentraxin Alfa arm.

Outcome measures

Outcome measures
Measure	Cohort A: Zinpentraxin Alfa n=11 Participants Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo n=36 Participants Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa n=28 Participants Participants entered, following participation in study WA42293.
Change in Carbon Monoxide Diffusing Capacity (DLCO) Baseline	40.20 DLCO% Predicted Standard Deviation 16.29	44.91 DLCO% Predicted Standard Deviation 10.94	42.27 DLCO% Predicted Standard Deviation 11.14
Change in Carbon Monoxide Diffusing Capacity (DLCO) Week 24	1.08 DLCO% Predicted Standard Deviation 4.05	—	-1.55 DLCO% Predicted Standard Deviation NA Cannot take the standard deviation from one participant.
Change in Carbon Monoxide Diffusing Capacity (DLCO) Week 48	-2.80 DLCO% Predicted Standard Deviation 3.76	—	—

SECONDARY outcome

Timeframe: From baseline until study completion (up to approximately 1.5 years)

Population: The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization.

Time to first occurrence of \>=10% absolute decline in % predicted FVC, \>=15% relative decline in 6MWD, or death

Outcome measures

Outcome measures
Measure	Cohort A: Zinpentraxin Alfa n=21 Participants Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo n=49 Participants Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa n=47 Participants Participants entered, following participation in study WA42293.
Time to Disease Progression	5.6 Months Interval 2.9 to 8.3	NA Months Due to the low number of events and early termination of the study, the median and 95% CI weren't estimable.	NA Months Due to the low number of events and early termination of the study, the median and 95% CI weren't estimable.

SECONDARY outcome

Timeframe: Every 6 Months and at study completion (up to approximately 1.5 years)

Population: The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization.

Outcome measures

Outcome measures
Measure	Cohort A: Zinpentraxin Alfa n=21 Participants Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo n=49 Participants Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa n=47 Participants Participants entered, following participation in study WA42293.
Survival	NA Months Due to the low number of events, the median and 95% CI was not estimable.	NA Months Due to the low number of events, the median and 95% CI was not estimable.	NA Months Due to the low number of events, the median and 95% CI was not estimable.

SECONDARY outcome

Timeframe: Every 6 Months and at study completion (up to approximately 1.5 years)

Population: The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization.

Outcome measures

Outcome measures
Measure	Cohort A: Zinpentraxin Alfa n=21 Participants Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo n=49 Participants Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa n=47 Participants Participants entered, following participation in study WA42293.
IPF-related Mortality	NA Months Due to the low number of events, the median and 95% CI was not estimable.	NA Months Due to the low number of events, the median and 95% CI was not estimable.	NA Months Due to the low number of events, the median and 95% CI was not estimable.

SECONDARY outcome

Timeframe: Every 6 Months and at study completion (up to approximately 1.5 years)

Population: The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization.

Outcome measures

Outcome measures
Measure	Cohort A: Zinpentraxin Alfa n=21 Participants Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo n=49 Participants Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa n=47 Participants Participants entered, following participation in study WA42293.
Respiratory-related Mortality	NA Months Due to the low number of events, the median and 95% CI was not estimable.	NA Months Due to the low number of events, the median and 95% CI was not estimable.	NA Months Due to the low number of events, the median and 95% CI was not estimable.

SECONDARY outcome

Timeframe: Days 1 and 5, Weeks 4, and 12

Population: The pharmacokinetic population included all randomized participants who received at least one administration (full or partial dose) of zinpentraxin alfa and at least one evaluable postdose PK sample that was above the lower limit of quantification (LLOQ).

Due to early termination of the study, only participants enrolled in Cohort A receiving at least one IV dose of zinpentraxin alfa had their plasma concentrations analyzed.

Outcome measures

Outcome measures
Measure	Cohort A: Zinpentraxin Alfa n=21 Participants Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa Participants entered, following participation in study WA42293.
Plasma Concentrations of PRM-151 at Specified Timepoints Day 1 - 2h Post Infusion	203.85 micrograms per millilitre (ug/mL) Standard Deviation 55.72	—	—
Plasma Concentrations of PRM-151 at Specified Timepoints Day 5 - Pre Infusion	42.83 micrograms per millilitre (ug/mL) Standard Deviation 18.89	—	—
Plasma Concentrations of PRM-151 at Specified Timepoints Day 5 - 2h Post Infusion	252.90 micrograms per millilitre (ug/mL) Standard Deviation 53.42	—	—
Plasma Concentrations of PRM-151 at Specified Timepoints Week 4 - Pre Infusion	2.50 micrograms per millilitre (ug/mL) Standard Deviation 0	—	—
Plasma Concentrations of PRM-151 at Specified Timepoints Week 4 - 2h Post Infusion	209.00 micrograms per millilitre (ug/mL) Standard Deviation 42.93	—	—
Plasma Concentrations of PRM-151 at Specified Timepoints Week 12 - Pre Infusion	2.50 micrograms per millilitre (ug/mL) Standard Deviation 0.00	—	—
Plasma Concentrations of PRM-151 at Specified Timepoints Week 12 - 2h Post Infusion	215.65 micrograms per millilitre (ug/mL) Standard Deviation 50.47	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1)

Population: The immunogenicity population included all randomized participants with at least one postdose ADA assessment and were grouped according to treatment received or, if no treatment is received prior to study discontinuation, according to treatment assigned.

Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed.

Outcome measures

Outcome measures
Measure	Cohort A: Zinpentraxin Alfa n=20 Participants Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa Participants entered, following participation in study WA42293.
Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline	0 Participants	—	—

SECONDARY outcome

Timeframe: Weeks 4, 12 and 24

Population: The immunogenicity population included all randomized participants with at least one postdose ADA assessment and were grouped according to treatment received or, if no treatment is received prior to study discontinuation, according to treatment assigned.

Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed.

Outcome measures

Outcome measures
Measure	Cohort A: Zinpentraxin Alfa n=20 Participants Participants entered this Cohort following participation in study PRM-151-202.	Cohort B: Ex-Placebo Participants entered, following participation in study WA42293.	Cohort B: Zinpentraxin Alfa Participants entered, following participation in study WA42293.
Percentage of Participants With ADAs During the Study	0 Percentage of Participants	—	—

Adverse Events

Cohort A Zinpentraxin Alfa

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Cohort B Ex-Placebo

Serious events: 8 serious events

Other events: 16 other events

Deaths: 2 deaths

Cohort B Zinpentraxin Alfa

Serious events: 6 serious events

Other events: 14 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Cohort A Zinpentraxin Alfa n=21 participants at risk Participants entered this Cohort following participation in study PRM-151-202.	Cohort B Ex-Placebo n=49 participants at risk Participants entered, following participation in study WA42293.	Cohort B Zinpentraxin Alfa n=47 participants at risk Participants entered, following participation in study WA42293.
Gastrointestinal disorders Diarrhoea	4.8% 1/21 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	6.1% 3/49 • Number of events 3 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	6.4% 3/47 • Number of events 4 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
General disorders Fatigue	9.5% 2/21 • Number of events 3 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	6.1% 3/49 • Number of events 3 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Infections and infestations Acute sinusitis	9.5% 2/21 • Number of events 2 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Infections and infestations Bronchitis	9.5% 2/21 • Number of events 2 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	6.1% 3/49 • Number of events 3 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	4.3% 2/47 • Number of events 2 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Infections and infestations COVID-19	19.0% 4/21 • Number of events 4 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	12.2% 6/49 • Number of events 6 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	8.5% 4/47 • Number of events 4 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Infections and infestations Lower respiratory tract infection	4.8% 1/21 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	8.2% 4/49 • Number of events 4 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	2.1% 1/47 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Injury, poisoning and procedural complications Infusion related reaction	9.5% 2/21 • Number of events 3 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	4.1% 2/49 • Number of events 4 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	8.5% 4/47 • Number of events 4 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Metabolism and nutrition disorders Vitamin B12 deficiency	9.5% 2/21 • Number of events 2 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Nervous system disorders Syncope	9.5% 2/21 • Number of events 2 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/21 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	2.0% 1/49 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	6.4% 3/47 • Number of events 3 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Respiratory, thoracic and mediastinal disorders Dyspnoea	23.8% 5/21 • Number of events 5 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	4.3% 2/47 • Number of events 2 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	9.5% 2/21 • Number of events 2 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Respiratory, thoracic and mediastinal disorders Sinus congestion	9.5% 2/21 • Number of events 2 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Skin and subcutaneous tissue disorders Pruritus	9.5% 2/21 • Number of events 2 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort A Zinpentraxin Alfa n=21 participants at risk Participants entered this Cohort following participation in study PRM-151-202.	Cohort B Ex-Placebo n=49 participants at risk Participants entered, following participation in study WA42293.	Cohort B Zinpentraxin Alfa n=47 participants at risk Participants entered, following participation in study WA42293.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/21 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	2.0% 1/49 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Cardiac disorders Atrial fibrillation	0.00% 0/21 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	2.0% 1/49 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/21 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	2.1% 1/47 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Gastrointestinal disorders Small intestinal obstruction	4.8% 1/21 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
General disorders Death	0.00% 0/21 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	4.1% 2/49 • Number of events 2 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
General disorders Vascular stent thrombosis	4.8% 1/21 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Immune system disorders Anaphylactic reaction	4.8% 1/21 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Infections and infestations Bacteraemia	4.8% 1/21 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Infections and infestations Pneumonia	4.8% 1/21 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	4.3% 2/47 • Number of events 2 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Infections and infestations Upper respiratory tract infection	0.00% 0/21 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	2.1% 1/47 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Infections and infestations Urosepsis	0.00% 0/21 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	2.0% 1/49 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	4.8% 1/21 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/21 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	2.1% 1/47 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	4.8% 1/21 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	4.1% 2/49 • Number of events 2 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	4.3% 2/47 • Number of events 2 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Vascular disorders Hypovolaemic shock	4.8% 1/21 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/49 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
Vascular disorders Microscopic polyangiitis	0.00% 0/21 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	2.0% 1/49 • Number of events 1 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.	0.00% 0/47 • AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.