Trial · NCT02632786

The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis

NCT02632786, Phase 2, Completed, Prothena Biosciences Ltd.; results first posted 2019-04-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis. Trials, record NCT02632786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02632786

On this page

Trial

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

Title: The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
NCT number: NCT02632786
Status: Completed
Phases: Phase 2
Enrollment: 129 participants, actual
Lead sponsor: Prothena Biosciences Ltd.
Conditions: AL Amyloidosis
Interventions: NEOD001, Placebo
First posted: 2015-12-17
Last updated: 2019-04-05
Results first posted: 2019-04-05

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Cardiac Response and Non-Response	Baseline through 12 months of treatment	N-terminal pro-brain natriuretic peptide (NT-proBNP ) best response (Response or Non-Response \[Stable, Progression\]) from baseline through 12 months of treatment. Cardiac best response, as assessed by NT-proBNP alone, is defined as the most favorable category among response (ie, decrease in NT-proBNP from baseline of \>30% and \>300 ng/L), stable (ie, neither response nor progression), and progression (ie, increase in NT-proBNP from baseline of \>30% and \>300 ng/L) across all visits after the first infusion of study drug up to and through the end of the study. Subjects are considered non-responders until a response is achieved. Non-response is defined as either stable or progression.
Secondary	SF-36v2 PCS Score	Baseline to 12 months of treatment	Change in Short Form-36 (SF-36 version 2) questionnaire Physical Component Summary \[PCS\] Score. PCS scores are calculated based on responses to specific Short Form-36 (version 2) questions using a weight scoring method. The lower the PCS score the more disability, the higher the score the less disability. A score of 50 is the mean in the US General Population and the standard deviation is 10. Minimum is 0 and maximum value is 100.
Secondary	6MWT Distance	Baseline to 12 months of treatment	Change in 6 Minute Walk Test (6MWT) Distance (meters)
Secondary	Number of Participants With Renal Best Response and Non-Response	Baseline through 12 months of treatment	Proteinuria and estimated Glomerular Filtration Rate (eGFR) response (Response or Non-Response \[Stable, Progression\]) from baseline through 12 months of treatment in subjects with renal involvement. Renal best response, as assessed by proteinuria, is defined as the most favorable category among response (ie, ≥30% decrease from baseline or \<0.5 g/24 hours postbaseline result if subject does not meet criteria for progression), stable (ie, neither response nor progression), and progression (ie, ≥25% decrease in eGFR from baseline) across all visits after the first infusion of study drug up to and through the end of the study. Subjects are considered non-responders until a response is achieved. Assessments that qualify as both a response and progression are counted as progression. Non-response is defined as either stable or progression.
Secondary	NIS-LL Total Score	Baseline to 12 months of treatment	Change in Neuropathy Impairment Score-Lower Limb (NIS-LL) Total Score in subjects with peripheral nerve involvement. NIS-LL is a scoring system graduated from 0 points to a maximum of 88 points (the absence of all motor, sensory, and reflex activity in the lower extremities). The scale is an additive of all deficits (64 potential points for muscle strength, 8 points for reflexes, and 16 points for sensory function) in the lower extremities. A score of 0 is normal and score of 88 is total impairment.
Secondary	NT-proBNP Slope	Baseline through 12 months of treatment	Rate of change in NT-proBNP (ng/L per infusion). Estimates of the intercept, slope, SE, and associated 95% CI for each treatment group, and the NEOD001 and placebo group difference comparisons are estimated using a general linear mixed effects model. The model fits a random intercept and slope for each subject and includes fixed effects for treatment group, time, treatment group by time interaction, IWRS stratification factors (hematologic response to first-line therapy: CR/VGPR, PR and NT-proBNP \<1800 ng/L, ≥1800 ng/L), and an unstructured covariance structure to model the within-subject errors. Time is represented in months as a continuous variable and includes all scheduled time points, including baseline. The p-value is associated with the visit by treatment group interaction term.
Secondary	Hepatic Best Response	Baseline through 12 months of treatment	Alkaline Phosphatase response (Response or Non-Response \[Stable, Progression\]) from baseline through 12 months of treatment in subjects with hepatic involvement

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Cardiac Response and Non-Response	Baseline through 12 months of treatment	ITT population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	SF-36v2 PCS Score	Baseline to 12 months of treatment	ITT population	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	6MWT Distance	Baseline to 12 months of treatment	ITT Population	meters	MEDIAN
SECONDARY	Number of Participants With Renal Best Response and Non-Response	Baseline through 12 months of treatment	Renal Evaluable Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	NIS-LL Total Score	Baseline to 12 months of treatment	Peripheral Neuropathy Evaluable Population	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	NT-proBNP Slope	Baseline through 12 months of treatment	ITT population	ng/L per infusion	MEAN
SECONDARY	Hepatic Best Response	Baseline through 12 months of treatment	Hepatic Evaluable Population	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Cardiac Response and Non-Response	NEOD001 24mg/kg	Response	26		Participants
Number of Participants With Cardiac Response and Non-Response	Placebo	Response	30		Participants
Number of Participants With Cardiac Response and Non-Response	NEOD001 24mg/kg	Non-response	40		Participants
Number of Participants With Cardiac Response and Non-Response	Placebo	Non-response	33		Participants
SF-36v2 PCS Score	NEOD001 24mg/kg		0.19	95% Confidence Interval -1.83 to 2.22	score on a scale
SF-36v2 PCS Score	Placebo		0.97	95% Confidence Interval -0.99 to 2.93	score on a scale
6MWT Distance	NEOD001 24 mg/kg		19.25	Inter-Quartile Range -21.75 to 59.37	meters
6MWT Distance	Placebo		8.00	Inter-Quartile Range -24.99 to 47.24	meters
Number of Participants With Renal Best Response and Non-Response	NEOD001 24 mg/kg	Response	7		Participants
Number of Participants With Renal Best Response and Non-Response	Placebo	Response	6		Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow10

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

Period	Milestone	Group	Participants
Overall Study	STARTED	NEOD001 24mg/kg	66
Overall Study	STARTED	Placebo	63
Overall Study	Informed Consent Obtained	NEOD001 24mg/kg	66
Overall Study	Informed Consent Obtained	Placebo	63
Overall Study	Randomized and Dosed	NEOD001 24mg/kg	66
Overall Study	Randomized and Dosed	Placebo	63
Overall Study	COMPLETED	NEOD001 24mg/kg	55
Overall Study	COMPLETED	Placebo	56
Overall Study	NOT COMPLETED	NEOD001 24mg/kg	11
Overall Study	NOT COMPLETED	Placebo	7

Source ClinicalTrials.gov

Adverse events160

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	6	66
other	Upper respiratory tract infection	Infections and infestations	Placebo	8	63
other	Nasopharyngitis	Infections and infestations	NEOD001 24 mg/kg	5	66
other	Nasopharyngitis	Infections and infestations	Placebo	4	63
other	Urinary tract infection	Infections and infestations	NEOD001 24 mg/kg	6	66
other	Urinary tract infection	Infections and infestations	Placebo	3	63
other	Respiratory tract infection	Infections and infestations	NEOD001 24 mg/kg	5	66
other	Respiratory tract infection	Infections and infestations	Placebo	2	63
other	Bronchitis	Infections and infestations	NEOD001 24 mg/kg	1	66
other	Bronchitis	Infections and infestations	Placebo	4	63

1 to 10 of 160Source ClinicalTrials.gov

See all 160 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	3	66
Total, all-cause mortality	Placebo	6	63
Total, other adverse events	NEOD001 24 mg/kg	58	66
Total, other adverse events	Placebo	52	63
Total, serious adverse events	NEOD001 24 mg/kg	14	66
Total, serious adverse events	Placebo	15	63

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 comparisons2

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

Comparison	Source
NEOD001 24 mg/kg vs Placebo: deaths from any cause	Trial comparisons
NEOD001 24 mg/kg vs Placebo: 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/NCT02632786

GET https://conductscience.org/api/trials/v1/NCT02632786/events?page=2

API reference For AI assistants