Trial · NCT02312206

The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis

NCT02312206, Phase 3, Terminated, Prothena Biosciences Ltd.; results first posted 2019-05-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis. Trials, record NCT02312206. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02312206

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
NCT number: NCT02312206
Status: Terminated
Phases: Phase 3
Enrollment: 260 participants, actual
Lead sponsor: Prothena Biosciences Ltd.
Conditions: Primary Systemic (AL) Amyloidosis
Interventions: NEOD001, Placebo
First posted: 2014-12-09
Last updated: 2023-11-14
Results first posted: 2019-05-29

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Composite of All-cause Mortality or Cardiac Hospitalization	Randomization until the date of death or cardiac hospitalization, up to 32 months	Time to all-cause mortality death occurring after the first infusion of study drug or cardiac hospitalization as adjudicated by the CEC occurring at least 91 days after first infusion of study drug through last subject last visit, whichever came first

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Composite of All-cause Mortality or Cardiac Hospitalization	Randomization until the date of death or cardiac hospitalization, up to 32 months	ITT Population	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Time to Composite of All-cause Mortality or Cardiac Hospitalization	NEOD001 (24 mg/kg) + Standard of Care	Number of Subjects Who Died or Experienced Cardiac Hospitalization	56	Participants
Time to Composite of All-cause Mortality or Cardiac Hospitalization	Placebo + Standard of Care	Number of Subjects Who Died or Experienced Cardiac Hospitalization	62	Participants
Time to Composite of All-cause Mortality or Cardiac Hospitalization	NEOD001 (24 mg/kg) + Standard of Care	Number of Subjects Censored	74	Participants
Time to Composite of All-cause Mortality or Cardiac Hospitalization	Placebo + Standard of Care	Number of Subjects Censored	68	Participants

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	NEOD001 (24 mg/kg) + Standard of Care	130
Overall Study	STARTED	Placebo + Standard of Care	130
Overall Study	Informed Consent Obtained	NEOD001 (24 mg/kg) + Standard of Care	130
Overall Study	Informed Consent Obtained	Placebo + Standard of Care	130
Overall Study	COMPLETED	NEOD001 (24 mg/kg) + Standard of Care	0
Overall Study	COMPLETED	Placebo + Standard of Care	0
Overall Study	NOT COMPLETED	NEOD001 (24 mg/kg) + Standard of Care	130
Overall Study	NOT COMPLETED	Placebo + Standard of Care	130

Source ClinicalTrials.gov

Adverse events490

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Constipation	Gastrointestinal disorders	NEOD001 (24 mg/kg) + Standard of Care	54	130
other	Constipation	Gastrointestinal disorders	Placebo + Standard of Care	55	130
other	Diarrhoea	Gastrointestinal disorders	NEOD001 (24 mg/kg) + Standard of Care	51	130
other	Diarrhoea	Gastrointestinal disorders	Placebo + Standard of Care	54	130
other	Nausea	Gastrointestinal disorders	NEOD001 (24 mg/kg) + Standard of Care	56	130
other	Nausea	Gastrointestinal disorders	Placebo + Standard of Care	43	130
other	Vomiting	Gastrointestinal disorders	NEOD001 (24 mg/kg) + Standard of Care	25	130
other	Vomiting	Gastrointestinal disorders	Placebo + Standard of Care	20	130
other	Abdominal distension	Gastrointestinal disorders	NEOD001 (24 mg/kg) + Standard of Care	15	130
other	Abdominal distension	Gastrointestinal disorders	Placebo + Standard of Care	15	130

1 to 10 of 490Source ClinicalTrials.gov

See all 490 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NEOD001 (24 mg/kg) + Standard of Care	41	130
Total, all-cause mortality	Placebo + Standard of Care	42	130
Total, other adverse events	NEOD001 (24 mg/kg) + Standard of Care	124	130
Total, other adverse events	Placebo + Standard of Care	125	130
Total, serious adverse events	NEOD001 (24 mg/kg) + Standard of Care	88	130
Total, serious adverse events	Placebo + Standard of Care	91	130

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37366170	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
NEOD001 (24 mg/kg) + Standard of Care vs Placebo + Standard of Care: deaths from any cause	Trial comparisons
NEOD001 (24 mg/kg) + Standard of Care vs Placebo + Standard of Care: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02312206

GET https://conductscience.org/api/trials/v1/NCT02312206/events?page=2

API reference For AI assistants