Trial · NCT05653219
A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
NCT05653219, 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 Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids. Trials, record NCT05653219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05653219
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 Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
- NCT number
- NCT05653219
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 152 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Primary Immune Thrombocytopenia
- Interventions
- Ianalumab, Eltrombopag, Placebo
- First posted
- 2022-12-16
- Last updated
- 2026-11-09
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time from randomization until treatment failure | Randomization to until end of study (up to 39 months after randomization of last participant) | Time from randomization until treatment failure is defined as the time from randomization date until the first of the following events indicative of treatment failure: * platelet count below 30 G/L * start of a new ITP treatment * need for a rescue treatment * ineligibility to taper or inability to discontinue eltrombopag * death |
| Secondary | Stable response at 6 months (Key Secondary Endpoint) | At 6 months | Percentage of participants with at least 3 platelet count collected at month 6 (between study days 121 and 183 and at least 75% of platelet counts qualified as a response). |
| Secondary | Complete Response rate at each timepoint | Randomization to until end of study (up to 39 months after randomization of last participant) | Percentage of participants with any platelet count of at least 100 G/L in the absence of rescue treatment or new ITP treatment |
| Secondary | Response rate at each timepoint | Randomization to until end of study (up to 39 months after randomization of last participant) | Percentage of participants with any platelet count of at least 50 G/L in the absence of rescue treatment or new ITP treatment |
| Secondary | Best response rate across all timepoints | Randomization to until end of study (up to 39 months after randomization of last participant) | Percentage of participants with a best response rate of either response or complete response |
| Secondary | Time to first response/time to first complete response | Time from randomization up to the longest observed treatment period duration | Time from randomization to date of first response and time from randomization to date of first complete response |
| Secondary | Duration of response | Randomization to until end of study (up to 39 months after randomization of last participant) | Time from achievement of response to treatment failure. |
| Secondary | Stable response at 1 year | At 1 year | Percentage of participants with at least 2 platelet count collected at year 1 (between study days 296 and 379 and at least 66% of platelet counts qualified as a response). |
| Secondary | Duration of complete response | Randomization to end of study (up to 39 months after randomization of last participant) | Time from achievement of complete response to loss of complete response stable response at 1 year period |
| Secondary | Rate of participants who successfully taper and discontinue eltrombopag in each treatment arm | up to week 24 | Probability to be treatment failure-free (as defined for the primary efficacy endpoint) |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41363800 | DERIVED |
Source PubMed
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/NCT05653219
GET https://conductscience.org/api/trials/v1/NCT05653219/registered?page=2