Trial · NCT02613182

Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

NCT02613182, Phase 2, Terminated, Prothena Biosciences Ltd.; results first posted 2019-05-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis. Trials, record NCT02613182. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02613182

On this page

Trial

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

Title: Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
NCT number: NCT02613182
Status: Terminated
Phases: Phase 2
Enrollment: 34 participants, actual
Lead sponsor: Prothena Biosciences Ltd.
Conditions: AL Amyloidosis
Interventions: NEOD001
First posted: 2015-11-24
Last updated: 2019-05-16
Results first posted: 2019-05-16

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Long-term Safety and Tolerability of NEOD001	From initiation of study drug through the last study visit or up to 30 days after date of last dose, whichever came first, assessed up to 24 months	Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome, or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

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	Long-term Safety and Tolerability of NEOD001	From initiation of study drug through the last study visit or up to 30 days after date of last dose, whichever came first, assessed up to 24 months		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group5

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

Outcome	Group	Category	Value	Units
Long-term Safety and Tolerability of NEOD001	NEOD001 24 mg/kg	Overall number of baseline subjects	34	Participants
Long-term Safety and Tolerability of NEOD001	NEOD001 24 mg/kg	Serious Adverse Events	12	Participants
Long-term Safety and Tolerability of NEOD001	NEOD001 24 mg/kg	Non-Serious Adverse Events	34	Participants
Long-term Safety and Tolerability of NEOD001	NEOD001 24 mg/kg	Death (all causes)	6	Participants
Long-term Safety and Tolerability of NEOD001	NEOD001 24 mg/kg	Death (from Adverse Events)	1	Participants

Source ClinicalTrials.gov

Participant flow4

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

Period	Milestone	Group	Participants
Overall Study	STARTED	NEOD001 24 mg/kg	34
Overall Study	Number of Patients Dosed	NEOD001 24 mg/kg	34
Overall Study	COMPLETED	NEOD001 24 mg/kg	0
Overall Study	NOT COMPLETED	NEOD001 24 mg/kg	34

Source ClinicalTrials.gov

Adverse events68

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	Upper respiratory tract infection	Infections and infestations	NEOD001 24 mg/kg	15	34
other	Urinary tract infection	Infections and infestations	NEOD001 24 mg/kg	3	34
other	Pneumonia	Infections and infestations	NEOD001 24 mg/kg	2	34
other	Oedema peripheral	Gastrointestinal disorders	NEOD001 24 mg/kg	9	34
other	Fatigue	General disorders	NEOD001 24 mg/kg	6	34
other	Pyrexia	General disorders	NEOD001 24 mg/kg	3	34
other	Chest discomfort	General disorders	NEOD001 24 mg/kg	2	34
other	Constipation	Gastrointestinal disorders	NEOD001 24 mg/kg	8	34
other	Diarrhoea	Gastrointestinal disorders	NEOD001 24 mg/kg	6	34
other	Abdominal pain	Gastrointestinal disorders	NEOD001 24 mg/kg	5	34

1 to 10 of 68Source ClinicalTrials.gov

See all 68 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NEOD001 24 mg/kg	6	34
Total, other adverse events	NEOD001 24 mg/kg	34	34
Total, serious adverse events	NEOD001 24 mg/kg	12	34

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

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

None in this release.

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/NCT02613182

GET https://conductscience.org/api/trials/v1/NCT02613182/events?page=2

API reference For AI assistants