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New treatment option for Primary Immune Thrombocytopenia
Official title Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab
ClinicalTrials.gov ID: NCT07039422
What this study is testing
What is Ianalumab?
Ianalumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary immune thrombocytopenia.
Also referred to as VAY736.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is intended to explore the efficacy and safety of a second course of ianalumab after experiencing treatment failure in the pivotal Primary Immune Thrombocytopenia (ITP) trials (CVAY736I12301, CVAY736Q12301) and after loss of durable response in the pivotal Warm Autoimmune Hemolytic Anemia (wAIHA) trial (CVAY736O12301).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Signed informed consent obtained prior to participation in the study.
- Male or female participants aged 18 years and older on the day of signing informed consent Primary ITP patients:
- Previously enrolled and treated either with ianalumab/placebo in addition to first-line corticosteroids on protocol CVAY736I12301 or with...
- Rescue medication and/or bridging therapy are allowed to be started within the 28 days prior to screening; platelet count results obtained prior to...
- Previously documented by a positive direct antiglobulin test (DAT) specific for anti-IgG or anti-IgA, previously enrolled and treated with...
You likely can't join if
- Evans syndrome or any cytopenia other than thrombocytopenia (for ITP participants) or anemia (for wAIHA), except for grade 1 anemia due to blood loss...
- Secondary wAIHA with BM involvement for wAIHA patients
- Current life-threatening bleeding or history of life-threatening bleeding due to thrombocytopenia
- Therapy for ITP or wAIHA other than ianalumab/placebo, bridging/rescue therapies and supportive care prior to the beginning of the screening window
- After primary analysis of each respective parent trial, participants whose treatment was unblinded and who received placebo only will be excluded.
- ITP participants only: Participants with concurrent coagulation disorders and/or receiving anti-platelet or anti-coagulant medication except for low...
See the full eligibility criteria
- Signed informed consent obtained prior to participation in the study.
- Male or female participants aged 18 years and older on the day of signing informed consent Primary ITP patients:
- Previously enrolled and treated either with ianalumab/placebo in addition to first-line corticosteroids on protocol CVAY736I12301 or with ianalumab/placebo in addition to eltrombopag in the second line on protocol...
- Rescue medication and/or bridging therapy are allowed to be started within the 28 days prior to screening; platelet count results obtained prior to the start of the therapy must be used to assess eligibility and have to...
- Previously documented by a positive direct antiglobulin test (DAT) specific for anti-IgG or anti-IgA, previously enrolled and treated with ianalumab/placebo in blinded cohort or placebo followed by crossover to open...
- Relapsed wAIHA with hemoglobin concentration ≥5 g/dL and \<10 g/dL and presence of symptoms related to anemia during screening or within 14 days before screening window or within 28 days before screening window if...
- Rescue medication and/or bridging therapy are allowed to be started during the screening and within 28 days prior to screening; hemoglobin level result for eligibility assessment needs to be obtained prior to the start...
- Supportive care is allowed in the case the participant received it in the parent trial when the relapse occurred and has remained stable at least 4 weeks prior screening
- Evans syndrome or any cytopenia other than thrombocytopenia (for ITP participants) or anemia (for wAIHA), except for grade 1 anemia due to blood loss or iron deficiency.
- Secondary wAIHA with BM involvement for wAIHA patients
- Current life-threatening bleeding or history of life-threatening bleeding due to thrombocytopenia
- Therapy for ITP or wAIHA other than ianalumab/placebo, bridging/rescue therapies and supportive care prior to the beginning of the screening window
- After primary analysis of each respective parent trial, participants whose treatment was unblinded and who received placebo only will be excluded.
- ITP participants only: Participants with concurrent coagulation disorders and/or receiving anti-platelet or anti-coagulant medication except for low dose of acetylsalicylic acid (≤150 mg per day) Other protocol-defined...
The study team makes the final eligibility decision.
Where it's taking place
- Buenos Aires, Argentina
- Roeselare, West-Vlaanderen, Belgium
- Guangzhou, Guangdong, China
- Dalian, Liaoning, China
- Tianjin, China
- Ostrava, Poruba, Czechia
- Caen, France
- Rennes, France
- Jena, Thuringia, Germany
- Debrecen, Hajdu Bihar Megye, Hungary
- Florence, FI, Italy
- Roma, RM, Italy
- Trieste, TS, Italy
- Vicenza, VI, Italy
- George Town, Malaysia
- Johor Bahru, Malaysia
- Kuala Selangor, Malaysia
- Bucharest, Romania
- Singapore, Singapore
- Barcelona, Spain
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buenos Aires, Argentina; Roeselare, West-Vlaanderen, Belgium; Guangzhou, Guangdong, China; Dalian, Liaoning, China; Tianjin, China; Ostrava, Poruba, Czechia and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.