BridgeMD
A phase 2 study of ianalumab in adults with primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) who have previously benefited from ianalumab.
EU CTIS ID: 2024-518231-11-00
What this study is testing
For participants with primary ITP: . To assess the benefit of a second course of ianalumab in participants with primary ITP who derived benefit from the initial course and subsequently relapsed For participants with wAIHA: . To assess the benefit of a second course of ianalumab in participants with wAIHA who had benefit to the initial course and subsequently relapsed.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent obtained prior to participation in the study
- Male and female participants aged 18 years and older on the day of signing informed consent
- Primary ITP patients: 3. 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 CVAY736Q12301, and who experienced treatment failure (TF) by parent trial definition ≥ 2 years after the last infusion of ianalumab/placebo
- Rescue medication and/or bridging therapy (See Section 6.6.3 and Section 6.6.4 for further details) 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 be collected within 30 days prior to screening
- for primary or secondary wAIHA patients: 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 label ianalumab in protocol CVAY736O12301, having experienced durable response lasting beyond 2 years from the last infusion of ianalumab/placebo in blinded cohorts or a durable response beyond week 20 from last dose of first course of ianalumab in the crossover arm
- for primary or secondary wAIHA patients: 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/bridging therapy has been initiated
You likely can't join if
- Evans syndrome or any cytopenia other than thrombocytopenia (for ITP participants) or anemia (for wAIHA participants), 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 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)
See the full eligibility criteria
Who can join
- Signed informed consent obtained prior to participation in the study
- Male and female participants aged 18 years and older on the day of signing informed consent
- Primary ITP patients: 3. 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 CVAY736Q12301, and who experienced treatment failure (TF) by parent trial definition ≥ 2 years after the last infusion of ianalumab/placebo
- Rescue medication and/or bridging therapy (See Section 6.6.3 and Section 6.6.4 for further details) 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 be collected within 30 days prior to screening
- for primary or secondary wAIHA patients: 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 label ianalumab in protocol CVAY736O12301, having experienced durable response lasting beyond 2 years from the last infusion of ianalumab/placebo in blinded cohorts or a durable response beyond week 20 from last dose of first course of ianalumab in the crossover arm
- for primary or secondary wAIHA patients: 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/bridging therapy has been initiated
- Rescue medication and/or bridging therapy (see Section 6.6.3 and Section 6.6.4 for further details) 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 of the treatment within 30 days prior to screening
- Supportive care (see Section 6.6.3 for further details) 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
What rules you out
- Evans syndrome or any cytopenia other than thrombocytopenia (for ITP participants) or anemia (for wAIHA participants), 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 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)
The study team makes the final eligibility decision.
Where it's taking place
- Singapore
- United States
- Turkey
- Mexico
- Japan
- Malaysia
- Taiwan
- Korea, Republic of
- Hong Kong
- Thailand
- India
- Vietnam
- United Kingdom
- Australia
- Argentina
- Israel
- China
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore; United States; Turkey; Mexico; Japan; Malaysia and 11 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 EU CTIS; the study team decides eligibility.