InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 15 August 2023

This phase I/II trial is trying to understand the safety and effectiveness of a targeted therapy (PRN1008) in people with relapsed Immune ThrombocytopeniaAn 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

Clinical summary


This is a 2 part, adaptive, open-label dose-finding study of PRN1008 in people with Immune Thrombocytopenic Purpura (ITP). Part A enrols people with ITP who are refractory or relapsed with no available and approved therapeutic options. Eligible patients have a platelet count <30,000 ¼l="" on="" two="" counts="" no="" sooner="" than="" 7="" days="" apart="" in="" the="" 15="" days="" before="" treatment="" begins.="" the="" active="" treatment="" period="" is="" 24="" weeks="" and="" the="" post-treatment="" follow-up="" period="" is="" 4="" weeks.="" in="" the="" dose-finding="" part="" of="" the="" study,="" each="" patient="" enrolled="" in="" the="" study="" is="" allowed="" to="" up-titrate="" their="" dose="" after="" 28="" days="" of="" prn1008="" therapy,="" if="" they="" do="" not="" experience="" a="" platelet="" response="" or="" a="" dose-limiting="" toxicity="" (dlt)="" at="" the="" last="" dose="" level.="" patients="" who="" respond="" to="" prn1008="" per="" protocol="" may="" enter="" a="" long="" term-extension.="" part="" b="" of="" the="" study="" will="" include="" people="" with="" itp="" who="" have="" relapsed="" or="" have="" insufficient="" response="" to="" prior="" therapies.="" eligible="" patients="" will="" have="" a="" platelet="" count=""><30,000 µl="" on="" two="" occasions="" no="" less="" than="" 7="" days="" apart,="" within="" 15="" days="" before="" treatment="" begins="" and="" a="" platelet="" count="" of="" ≤35,000/âµl="" on="" study="" day="" 1="" (sd1).="" the="" study="" consists="" of="" a="" 28-day="" screening="" period,="" 24-week="" active="" treatment="" period,="" and="" a="" long-term="" extension.="" after="" the="" last="" dose="" of="" prn1008="" there="" will="" be="" a="" 4-week="" safety="" follow-up="">


This trial is treating patients with Immune Thrombocytopenia.


Blood Cancers Blood


People18 - 80



More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT03395210
  • 2019.282 PRINCIPIA BIOPHARMA - PRN1008-010 - CT1191

Commercial Sponsor

Principia Biopharma, a Sanofi Company

Scientific Title

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



  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.


  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support


Cancer Connect

Speak with someone who has cancer clinical trial experience.

Learn more


Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more


Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.


Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.