Trial · NCT05648968
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Binary variable indicating whether a patient achieves a durable response | Randomization to Week 25 | Durable response: hemoglobin level ≥10 g/dL and ≥2 g/dL increase from baseline, for a period of at least eight consecutive weeks between W9 and W25, in the absence of rescue medication or prohibited treatment |
| Secondary | Duration of response (Key Secondary) | Randomization to end of study (up to 39 months after randomization of last patient) | • For patients who previously reached durable response: Time from first hemoglobin assessment showing durable response to confirmed loss of durable response, defined as the first of the following events: * hemoglobin level \<10 g/dL in at least two consecutive weekly assessments, * start of any rescue medication or prohibited treatment, * death; • For patients who did not achieve the durable response according to primary endpoint definition: duration will be 0 days |
| Secondary | Time from randomization to start of durable response in each treatment group | Randomization to end of study (up to 39 months after randomization of last patient) | Durable response is defined as in primary endpoint. |
| Secondary | Time from randomization to start of first response in each treatment group | Randomization to end of study (up to 39 months after randomization of last patient) | Response is defined as hemoglobin level of at least 10 g/dL and an increase of at least 2 g/dl from baseline, or normalization of hemoglobin (at least 11 g/dL for women and 12 g/dL for men), without biochemical resolution of hemolysis. |
| Secondary | Time from randomization to start of complete response in each treatment group | Randomization to end of study (up to 39 months after randomization of last patient) | Complete response is defined as normalization of hemoglobin levels and no evidence of hemolysis (normal levels of indirect bilirubin, LDH, haptoglobin and reticulocytes), in the absence of red blood cell transfusions. |
| Secondary | Response rate | Randomization to end of study (up to 39 months after randomization of last patient) | Assessment of quality of response in each treatment group. |
| Secondary | Complete response rate | Randomization to end of study (up to 39 months after randomization of last patient) | Assessment of complete response rate in each treatment group. |
| Secondary | Hemoglobine Levels | Randomization to end of study (up to 39 months after randomization of last patient) | Assessment of hemoglobin levels in each treatment group. |
| Secondary | Number of participants who received rescue treatment (overall & by type of rescue treatment) | Randomization to end of study (up to 39 months after randomization of last patient) | This is to assess the need for rescue treatment in all treatment groups, measured as time-standardized numbers of each type of rescue treatment and as change from baseline in time-standardized number of transfusions. |
| Secondary | Percentage of participants who received rescue treatment (overall & by type of rescue treatment) | Randomization to end of study (up to 39 months after randomization of last patient) | This is to assess the need for rescue treatment in all treatment groups. |
| Secondary | Change from baseline in the the frequency and absolute number of CD19+ B cell counts | Randomization to end of study (up to 39 months after randomization of last patient) | Change from baseline in the the frequency and absolute number of CD19+ B cell counts in whole blood |
| Secondary | Time to first occurrence of B cell recovery, defined as ≥80% of baseline or ≥50 cells/μL | Randomization to end of study (up to 39 months after randomization of last patient) | Time to first occurrence of B cell recovery, defined as ≥80% of baseline or ≥50 cells/μL in whole blood |
| Secondary | Change from baseline in immunoglobulin levels | Randomization until month 30 | Change from baseline in immunoglobulin levels (change in titers of IgG, IgM, IgA) |
| Secondary | Change from baseline in the 8 domain scores and in the summary scores (PCS, MCS) of SF-36 questionnaire | Randomization to end of study (up to 39 months after randomization of last patient) | SF-36 v2.0 (acute) includes 36 items that assess general health related quality of life covering 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role-emotional health and mental health. Scores for the 8 domains are generated, as well as a physical component summary (PCS) score and a mental component summary (MCS) score. Responses to items are based on a 5-point Likert scale. Scores below 50 indicate less than average health, while scores above 50 indicate better than average health. |
| Secondary | Change from baseline in the T-score of PROMIS Fatigue-13a questionnaire | Randomization to end of study (up to 39 months after randomization of last patient) | Assessment of quality of life in each treatment group. The PROMIS Short Form v1.0 Fatigue-13a includes 13 items that assess fatigue. All items in the PROMIS-Fatigue-13a utilize a 5-point response scale (e.g., not at all, a little bit, somewhat, quite a bit, very much). Higher scores on the PROMIS-Fatigue-13a represent greater fatigue. |
| Secondary | Ianalumab PK parameter - AUClast | After first dose of study treatment (pre-dose, 2 hours, 336 hours, 672 hours post dose) and after last dose (pre-dose, 2 hours, 336 hours, 672 hours, 1344 hours, 2016 hours and 3360 hours post dose). | AUClast: area under the curve from time zero to last measurable concentration sampling time (tlast). |
| Secondary | Ianalumab PK parameter - AUCtau | After first dose of study treatment (pre-dose, 2 hours, 336 hours, 672 hours post dose) and after last dose (pre-dose, 2 hours, 336 hours, 672 hours, 1344 hours, 2016 hours and 3360 hours post dose). | AUCtau: the AUV calculated to the end of a dosing interval (tau). |
| Secondary | Ianalumab PK parameter - Accumulation ratio Racc | After last dose (pre-dose, 2 hours, 336 hours, 672 hours, 1344 hours, 2016 hours and 3360 hours post dose). | Accumulation ratio calculated using AUC values obtained between last and first dose |
| Secondary | Ianalumab PK parameter - Cmax | After first dose of study treatment (pre-dose, 2 hours, 336 hours, 672 hours post dose) and after last dose (pre-dose, 2 hours, 336 hours, 672 hours, 1344 hours, 2016 hours and 3360 hours post dose). | Maximum (peak) observed plasma, blood, serum or other body fluid drug concentration |
| Secondary | Ianalumab PK parameter - Tmax | After first dose of study treatment (pre-dose, 2 hours, 336 hours, 672 hours post dose) and after last dose (pre-dose, 2 hours, 336 hours, 672 hours, 1344 hours, 2016 hours and 3360 hours post dose). | Time to reach maximum (peak) 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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