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Monoclonal Antibodies
The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis (PRONTO Trial)
Phase 2
Waitlist Available
Research Sponsored by Prothena Biosciences Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months of treatment
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.
Eligible Conditions
- AL Amyloidosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 months of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Cardiac Response and Non-Response
Secondary study objectives
6MWT Distance
Hepatic Best Response
NIS-LL Total Score
+3 moreSide effects data
From 2018 Phase 2 trial • 129 Patients • NCT0263278621%
Fatigue
20%
Diarrhoea
14%
Headache
12%
Cough
11%
Dyspnoea
11%
Oedema peripheral
11%
Constipation
9%
Nausea
9%
Vomiting
9%
Upper respiratory tract infection
9%
Urinary tract infection
9%
Muscle spasms
9%
Anaemia
8%
Respiratory tract infection
8%
Back pain
8%
Dizziness
8%
Hypoaesthesia
8%
Nasopharyngitis
8%
Haematuria
6%
Productive cough
6%
Paraesthesia
6%
Epistaxis
6%
Atrial fibrillation
6%
Pyrexia
6%
Asthenia
5%
Abdominal distension
5%
Hypertension
5%
Hypocalcaemia
3%
Rash
3%
Cellulitis
3%
Pleural effusion
3%
Blood creatinine increased
3%
Syncope
3%
Bradycardia
3%
Hypotension
2%
Sepsis
2%
Pericardial effusion
2%
Bronchitis
2%
Acute kidney injury
2%
Respiratory failure
2%
Deep vein thrombosis
2%
Bacteraemia
2%
Ureteric obstruction
2%
Transient ischaemic attack
2%
Gastritis
2%
Fluid overload
2%
Metabolic syndrome
2%
Intervertebral disc protrusion
2%
Malignant urinary tract neoplasm
2%
Angina pectoris
2%
Atrioventricular block complete
2%
Cardiac arrest
2%
Contusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
NEOD001 24 mg/kg
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NEOD001Experimental Treatment1 Intervention
Study Drug given IV every 28 days at 24mg/kg
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Birtamimab
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Prothena Biosciences Ltd.Lead Sponsor
7 Previous Clinical Trials
1,054 Total Patients Enrolled
3 Trials studying AL Amyloidosis
457 Patients Enrolled for AL Amyloidosis