Trial · NCT05648968
A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia
NCT05648968, Phase 3, Active not recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia. Trials, record NCT05648968. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05648968
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia
- NCT number
- NCT05648968
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 90 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Warm Autoimmune Hemolytic Anemia (wAIHA)
- Interventions
- Ianalumab, Placebo
- First posted
- 2022-12-13
- Last updated
- 2026-09-11
- Other registries' IDs
- eudract:2022-001773-31
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05648968
GET https://conductscience.org/api/trials/v1/NCT05648968/registered?page=2