Trial · NCT05885555
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmed response | Between Week 1 Day 1 and Week 25 Day 1 | Confirmed response is defined as a platelet count of equal or above 50 G/L at two (or more) consecutive assessments at least 7 days apart, in the absence of: * Rescue treatment for ≥4 weeks prior to the assessment of the platelet count, and * New immune thrombocytopenia (ITP) treatment before reaching a confirmed response. |
| Secondary | Time to confirmed response | From Week 1 Day 1 to Week 25 Day 1 | Time from the first administration of ianalumab to the first assessment in the first sequence of two (or more) platelet assessments meeting the criteria of a confirmed response as defined by the primary endpoint. |
| Secondary | Duration of confirmed response | From Week 1 Day 1 to end of study (until all participants have completed 24 months of safety follow-up since their last dose of ianalumab or discontinued the study earlier) | Time from the first assessment in the first sequence of two (or more) platelet assessments meeting the criteria of a confirmed response to loss of response; with loss of response defined as the first of the following events: * platelet count \<30 G/L, * start of any rescue or new ITP treatment, * death (whatever the cause). |
| Secondary | Complete Response rate at each timepoint | From Week 1 Day 1 to end of study (until all participants have completed 24 months of safety follow-up since their last dose of ianalumab or discontinued the study earlier) | Percentage of participants with a platelet count of at least 100 G/L in the absence of rescue treatment/new ITP treatment. |
| Secondary | Response rate at each timepoint | From Week 1 Day 1 to end of study (until all participants have completed 24 months of safety follow-up since their last dose of ianalumab or discontinued the study earlier) | Percentage of participants with a platelet count of at least 50 G/L in the absence of rescue treatment/new ITP treatment. |
| Secondary | Stable response at 6 months | At 6 months | Percentage of participants with at least 75% of platelet counts collected at month 6 (between study days 121 and 183) equal to or above 50 G/L in the absence of rescue treatment/new ITP treatment. |
| Secondary | Stable response at 1 year | At 1 year | Percentage of participants with at least 66% of platelet counts collected at year 1 (between study days 296 and 379) equal to or above 50 G/L in the absence of rescue treatment/new ITP treatment. |
| Secondary | Bleeding events according to the Modified World Health Organization (WHO) bleeding scale | From Week 1 Day 1 to end of study (until all participants have completed 24 months of safety follow-up since their last dose of ianalumab or discontinued the study earlier) | Number of participants reporting bleeding events for each grade of the World Health Organization (WHO) bleeding scale at each time point. Severity is graded from 0 to 4, with 0 = no bleeding and 4 = severe hemodynamic instability/central nervous system (CNS) bleeding/fatal. |
| Secondary | Percentage of participants with bleeding events according to the Modified World Health Organization (WHO) bleeding scale | From Week 1 Day 1 to end of study (until all participants have completed 24 months of safety follow-up since their last dose of ianalumab or discontinued the study earlier) | Percentage of participants reporting bleeding events for each grade of the WHO bleeding scale at each time point. Severity is graded from 0 to 4, with 0 = no bleeding and 4 = severe hemodynamic instability/central nervous system (CNS) bleeding/fatal. |
| Secondary | Number of participants who received rescue treatment | From Week 1 Day 1 to end of study (until all participants have completed 24 months of safety follow-up since their last dose of ianalumab or discontinued the study earlier) | Number of participants who required rescue treatment |
| Secondary | Percentage of participants who received rescue treatment | From Week 1 Day 1 to end of study (until all participants have completed 24 months of safety follow-up since their last dose of ianalumab or discontinued the study earlier) | Percentage of participants who required rescue treatment |
| Secondary | Change from baseline in the frequency of CD19+ B-cell counts | From Week 1 Day 1 to end of study (until all participants have completed 24 months of safety follow-up since their last dose of ianalumab or discontinued the study earlier) | Post-baseline frequency of CD19+ B-cell counts compared to baseline |
| Secondary | Change from baseline in the absolute number of CD19+ B-cell counts | From Week 1 Day 1 to end of study (until all participants have completed 24 months of safety follow-up since their last dose of ianalumab or discontinued the study earlier) | Post-baseline absolute number of CD19+ B-cell counts compared to baseline |
| Secondary | Time to first occurrence of B-cell recovery defined as ≥80% of baseline ≥50 cells/µL | From Week 1 Day 1 to end of study (until all participants have completed 24 months of safety follow-up since their last dose of ianalumab or discontinued the study earlier) | Time to B-cell recovery defined as ≥80% of baseline or ≥50 cells/µL |
| Secondary | Change from baseline in immunoglobulins | From Week 1 Day 1 to end of study (until all participants have completed 24 months of safety follow-up since their last dose of ianalumab or discontinued the study earlier) | Post-baseline immunoglobulin levels (change in titers of Total Ig, IgG, IgM, IgA) compared to baseline |
| Secondary | Incidence of anti-ianalumab antibodies in serum (ADA assay) over time | Up to 20 weeks after last dose of ianalumab | Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants to assess the immunogenicity of ianalumab |
| Secondary | Titer of anti-ianalumab antibodies in serum (ADA assay) over time | Up to 20 weeks after last dose of ianalumab | Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants to assess the immunogenicity of ianalumab |
| Secondary | Ianalumab serum concentrations over time | First dose (pre-dose, 2, 168, 336, 504, 672 hours post-dose); Subsequent doses (pre-dose and 2 hours post-dose); Last dose (pre-dose, 2 336, 672, 1344, 2016, 3360 hours post-dose) | Ianalumab concentration in serum over time, including end of infusion and concentration at trough. |
| Secondary | Ianalumab serum PK: AUC concentrations over time | First dose (pre-dose, 2, 168, 336, 504, 672 hours post-dose); Subsequent doses (pre-dose and 2 hours post-dose); Last dose (pre-dose, 2 336, 672, 1344, 2016, 3360 hours post-dose) | Ianalumab concentration in serum over time, including end of infusion and concentration at trough. |
| Secondary | Ianalumab serum PK parameters: Cmax | First dose (pre-dose, 2, 168, 336, 504, 672 hours post-dose); Subsequent doses (pre-dose and 2 hours post-dose); Last dose (pre-dose, 2 336, 672, 1344, 2016, 3360 hours post-dose) | Maximum (peak) observed plasma, blood, serum or other body fluid drug concentration |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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