Previously active trials
All Types of Amyloid
None currently
Systemic Light Chain Amyloidosis (AL) trials
- A Single Arm, Open-Label, Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis. The first part of the study is phase 1 dose-escalation and the second part will be phase 2.
- An orally bioavailable inhibitor of the anti-apoptotic protein B-cell lymphoma 2(Bcl-2), with potential pro-apoptotic and antineoplastic activities. Upon oral administration, Bcl-2 inhibitor ZN-d5 targets, binds to and inhibits the activity of Bcl-2.
- A Phase 3 Randomized, MultI-Centre Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs Placebo Plus Standard of Care in Newly Diagnosed Mayo Stage IV Subjects with Light Chain AL Amyloidosis
- Birtamimab is a humanized monoclonal antibody being investigated as a treatment for amyloid light chain (AL) amyloidosis and potentially AA amyloidosis.
Transthyretin Amyloidosis (ATTR) trials
What is the drug in question?
ALXN2220 is a recombinant human anti-ATTR antibody that was developed for the removal of ATTR by phagocytic immune cells.
What does the study hope to prove?
Efficacy of ALXN2220 in the treatment od ATTR cardiomyopathy.
Who is eligible for the trial?
Male or Female between 18 and 90 years of age with confirmed ATTR-CM.
Does every patient receive the actual trial drug?
Randomisation is in 2:1 ratio to receive either study drug (2/3) or placebo (1/3).
How is the drug administered?
By intravenous infusion every 4 weeks.
How long does the trial go for?
48 months
Key inclusion criteria:
Subjects with confirmed ATTR-CM, history or current heart failure (class 2-4 NYHA dyspnoea) and elevated cardiac biomarkers (NTproBNP).
Key exclusion criteria:
- Other non TTR types of amyloidosis
- Cardiomyopathy caused by other condition
- Recent (within 3 months) acute CV event
- Low LV ejection fraction (<30%)
- Severe non cardiac medical illness (lung, liver, kidney)
- Malignancy within last 5 years
- Solid organ recipient
- Low body weight (<40kg)
Where to go for more information:
See below.
Sites
Victoria
| Status: | |
| Site: | Eastern health (Box Hill Hospital), Melbourne |
| Status: | |
| Site: | The Alfred, Melbourne |
Queensland
| Status: | |
| Site: | Princess Alexandra Hospital, Brisbane |
| Contact: | Amyloidosis@health.qld.gov.au |
New South Wales
| Status: | |
| Site: | Westmead Hospital, Sydney |
| Contact: | WSLHD-TTRtrials@health.nsw.gov.au |
| Status: | |
| Site: | St Vincent’s Hospital, Sydney |
Western Australia
| Status: | |
| Site: | Joondalup, Perth |
South Australia
| Status: | |
| Site: | Flinders Medical Centre |
| Contact: | Name: Fiona Wollaston Email: fiona.wollaston2@sa.gov.au |
- This is a Phase 2 open-label extension study to evaluate the long-term safety, tolerability, and clinical activity of AT-02.
- AT-02 is a therapeutic candidate developed by Attralus for treating systemic amyloidosis. It’s a fusion protein consisting of a pan-amyloid removal (PAR) peptide technology and a humanized IgG1 antibody. The PAR peptide binds to all types of amyloid and delivers the antibody to the amyloid deposits, stimulating the immune system to remove the amyloid.
- A phase 1, randomized, placebo-controlled, double-blind, dose escalation trial combining single-ascending dose and multiple-ascending dose phases of NI006 or placebo, followed by an open-label extension phase in subjects with Amyloid Transthyretin Cardiomyopathy (ATTR-CM).
- NI006 is a recombinant human anti-ATTR antibodythat was developed for the removal of ATTR by phagocytic immune cells.
