Working... Menu
Trial record 1 of 1 for:    NCT02632786
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02632786
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : April 17, 2018
Information provided by (Responsible Party):
Prothena Therapeutics Ltd.

Brief Summary:
This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and have persistent cardiac dysfunction.

Condition or disease Intervention/treatment Phase
AL Amyloidosis Drug: NEOD001 Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis Who Have Persistent Cardiac Dysfunction
Study Start Date : March 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Arm Intervention/treatment
Experimental: NEOD001
Study Drug given IV every 28 days at 24mg/kg
Drug: NEOD001
NEOD001 is a monoclonal antibody directed at soluble and insoluble light chain aggregates

Placebo Comparator: Placebo
Drug: Placebo
Saline Bag

Primary Outcome Measures :
  1. Cardiac best response as measured by NT-proBNP [ Time Frame: Baseline to 12 months ]

Secondary Outcome Measures :
  1. Change in Short Form-36 (SF-36) Questionnaire [ Time Frame: Baseline to 12 months ]
  2. Change in 6MWT [ Time Frame: Baseline to 12 months ]
  3. Renal best response as measured by proteinuria [ Time Frame: Baseline to 12 Months ]
  4. Change in Neuropathy Impairment Score- Lower Limb (NIS-LL) score [ Time Frame: Baseline to 12 Months ]
  5. NT-proBNP slope [ Time Frame: Baseline to 12 Months ]
  6. To assess the safety of single agent NEOD001 by assessing vital signs, electrocardiogram(ECG),laboratory tests and AEs [ Time Frame: Baseline to 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥18 years
  2. Confirmed diagnosis of systemic AL amyloidosis
  3. ≥1 prior systemic plasma cell dyscrasia therapy with at least a partial hematologic response
  4. Cardiac involvement
  5. NT-proBNP ≥650

Exclusion Criteria:

  1. Non-AL amyloidosis
  2. Meets the International Myeloma Working Group (IMWG) definition of Multiple Myeloma
  3. NT-proBNP >5000
  4. Received Plasma cell directed chemotherapy within 6 months
  5. Received autologous stem cell transplant (ASCT) within 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02632786

  Show 40 Study Locations
Sponsors and Collaborators
Prothena Therapeutics Ltd.

Layout table for additonal information
Responsible Party: Prothena Therapeutics Ltd. Identifier: NCT02632786     History of Changes
Other Study ID Numbers: NEOD001-201
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: March 2018

Keywords provided by Prothena Therapeutics Ltd.:
plasma cell dyscrasia

Additional relevant MeSH terms:
Layout table for MeSH terms
Immunoglobulin Light-chain Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases