ITP Clinical Trials
Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. Some investigations look at how people respond to a new intervention and what side effects might occur while others help to determine the best dose of a particular treatment is effective.
There are a number of Clinical Trials available in Australia for the treatment of Immune Thrombocytopenia, which further information available below.
In addition, there are clinical trials being held internationally. You can review a complete list by visiting ClinicalTrials.gov.
Clinical Trial Register
Status
Trial
Sponsor
Trial Summary
Recruiting.
Locations:
Prahran, VIC
Drug: Ianalumab
ClinicalTrials.gov ID: NCT05885555
Pharma Trial ID: CVAY736Q12201
Novartis Pharmaceuticals
Ianalumab
This is a phase 2, open-label, single-arm study to evaluate the efficacy, safety and tolerability of ianalumab in participants with primary ITP (platelet count <30 G/L at screening) previously treated with at least a corticosteroid and a TPO-RA.
The study consists of the screening period, the primary endpoint assessment period, the follow-up period. The screening period will last for up to 14 days prior to the first dose of ianalumab. All eligible participants will be treated with the same dose of ianalumab and will complete the primary endpoint assessment period. After completion of the primary endpoint assessment period, all participants will continue in safety monitoring and those with a platelet count ≥30 G/L in absence of a new line of ITP therapy and rescue therapy will also continue in efficacy monitoring. The study will end once all participants have completed 24 months of safety follow-up since their last dose of ianalumab or discontinued the study earlier.
Recruiting.
Locations:
Douglas, QLD,
Liverpool, NSW
Westmead, NSW
Box Hill, VIC
West Perth, WA
Drug: povetacicept (ALPN-303)
ClinicalTrials.gov ID: NCT05757570
Pharma Trial ID: AIS-D04
Alpine Immune Sciences, Inc.
RUBY-4
The goal of this clinical study is to evaluate povetacicept (ALPN-303) in adults with autoimmune cytopenias of immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month study treatment extension period.
Recruiting.
Locations:
Canberra, ACT
Woolloongabba, QLD
Clayton, VIC
Prahran, VIC
Drug: Ianalumab
ClinicalTrials.gov ID: NCT05653349
Pharma Trial ID: CVAY736I12301
Novartis Pharmaceuticals
Ianalumab
A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1)
The purpose of this study is to evaluate the effect of two different doses of Ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 G/L in adult participants with primary ITP.
Recruiting.
Locations:
Kogarah, NSW
Liverpool, NSW
Mount Kuring-Gai, NSW
Waratah, NSW
Bedford Park, SA
Melbourne, VIC
Drug: PF-06835375
ClinicalTrials.gov ID: NCT05070845
Pharma Trial ID: C1131003
Pfizer
PF-06835375
An Interventional Phase 2, Open-label, multi-centre study to evaluate safety and efficacy of PR-06835375 in adult participants with moderate to severe primary Immune Thrombocytopenia.
This is a Phase 2, open-label, multicenter, multiple subcutaneous injections, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP). This study will focus on participants with persistent (>3 months and ≤12 months) or chronic (>12 months) ITP.
Recruiting.
Locations:
Garran, ACT
West Perth, WA
Westmead, NSW
Drug: Efgartigimod PH20 SC
ClinicalTrials.gov ID: NCT04812925
Pharma Trial ID: ARGX-113-2005
Argenx
ADVANCESC+ Study
A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia.
This is a phase 3, multicenter, open-label, long-term trial to evaluate the efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in adult patients with primary ITP.
Recruiting.
Locations:
Adelaide, SA
Frankston, VIC
Kogarah, NSW
Perth, WA
South Brisbane, QLD
Westmead, NSW
Drug: Rilzabrutinib (PRN1008)
ClinicalTrials.gov ID: NCT04562766
Pharma Trial ID: PRN1008-018
Sanofi
LUNA 3 – Rilzabrutinib
This is a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of <30,000/μL (and no single platelet count >35,000/μL) on two counts at least 5 days apart in the 14 days before treatment begins. Patients will receive rilzabrutinib or placebo 400mg twice daily.
For each patient, the study will last up to 60 weeks from the start of the Screening Period to the End of Study (EOS) visit. This includes Screening (up to 4 weeks) through a 12 to 24-week Blinded Treatment Period followed by a 28-week Open-Label Period. Followed by a 4-week post dose follow-up.
Patients who respond per specified criteria at the end of the Open-Label Period will be able to enter the Long-Term Extension (LTE) where they will continue to receive treatment until the last patient who enters the LTE has completed 12 months.
Active. Not Recruiting.
Locations:
Adelaide, SA
Bedford Park, SA
Box Hill, VIC
Clayton, VIC
Garran, ACT
Hobart, TAS
Perth, WA
West Perth, WA
Westmead, NSW
Drug: Efgartigimod PH20 SC
ClinicalTrials.gov ID: NCT04687072
Pharma Trial ID: ARGX-113-2004
Argenx
ADVANCESC Study
A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia.
This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.
Active. Not Recruiting.
Locations:
Garran, ACT
Concord, NSW
Brisbane, QLD
Clayton, VIC
Parkville, VIC
Nedlands, WA
Drug: Rilzabrutinib (PRN1008)
ClinicalTrials.gov ID: NCT03395210
Pharma Trial ID: PRN1008-010
Sanofi
Rilzabrutinib – Oral BTK Inhibitor
An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenia.
This is a 2 part (Part A and B) adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/μL on two counts, no sooner than 7 days apart in the 15 days before treatment begins. The dose-finding portion of the study has been completed. Part B treatment dose is 400 mg twice daily.
Contact ITP Australia today to ensure your Clinical Trial is included in our register.
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