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

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ClinicalTrials.gov Identifier: NCT02632786
Recruitment Status : Active, not recruiting
First Posted : December 17, 2015
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis
U.S. FDA Resources

Arms and Interventions

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
Placebo
Drug: Placebo
Saline Bag


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02632786


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Sponsors and Collaborators
Prothena Therapeutics Ltd.
More Information

Responsible Party: Prothena Therapeutics Ltd.
ClinicalTrials.gov Identifier: NCT02632786     History of Changes
Other Study ID Numbers: NEOD001-201
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Keywords provided by Prothena Therapeutics Ltd.:
amyloidosis
ntprobnp
NEOD001
Prothena
PRONTO
amyloid
plasma cell dyscrasia
immunotherapy

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases