Trial · NCT05653349
Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
NCT05653349, Phase 3, Active not recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP). Trials, record NCT05653349. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05653349
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
- NCT number
- NCT05653349
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 226 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Primary Immune Thrombocytopenia (ITP)
- Interventions
- Ianalumab, Placebo, Corticosteroids
- First posted
- 2022-12-16
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Stable Response off treatment at 12 months (SROT-12) | 12 months after last patient completed treatment | A participant will be considered in SROT-12 if at least 75% of the platelet counts collected between visits Week 53 Day 1 and Week 65 Day 1 (Study Days 352 and 463) qualify as Response. Response is any platelet counts of at least 50 G/L in the absence of rescue treatment or new immune thrombocytopenia (ITP) treatment). |
| Secondary | Time from randomization to Treatment Failure (TTF) (Key Secondary Endpoint) | Randomization to end of study (up to 39 months after randomization of last patient | Time to Treatment Failure (TTF) is defined as the time from randomization until the first of the following events/situation indicative of treatment failure: platelet count below 30 G/L later than 8 weeks from randomization, need for a rescue treatment later than 8 weeks from randomization, intake of rescue treatment (e.g., corticosteroids, Intravenous immunoglobulins (IVIG), or platelet transfusion) given later than 8 weeks from randomization, start of new Immune Thrombocytopenia (ITP) treatment whenever it occurs, death (whatever the cause). |
| Secondary | Complete Response (CR) rate in each treatment group | Randomization to end of study (up to 39 months after randomization of last patient) | Complete Response (CR) rate at each timepoint defined as the proportion of participants with any platelet count of at least 100 G/L in the absence of rescue treatment or new ITP treatment. |
| Secondary | Response (R) rate in each treatment group | Randomization to end of study (up to 39 months after randomization of last patient) | Response (R) rate at each timepoint defined as the proportion of participants with any platelet count of at least 50 G/L in the absence of rescue treatment or new ITP treatment. |
| Secondary | Time to complete response in each treatment group | Randomization to end of study (up to 39 months after randomization of last patient) | Time from randomization to date of first complete response. |
| Secondary | Duration of response in each treatment group | Randomization to end of study (up to 39 months after randomization of last patient) | Time from achievement of complete response to loss of complete response |
| Secondary | Stable response at 6 months | At 6 months | Percentage of participants with at least 2 platelet count collected at month 6 (between study dates 107 and 183) and at least 66% of platelet counts qualified as a response |
| Secondary | Stable response at 1 year | At 1 year | Percentage of participants with at least 2 platelet counts collected at year 1 (between study days 296 and 379) and at least 66% of platelet counts qualified as a response |
| Secondary | Percentage of participants with bleeding events overall and by World Health Organization (WHO) bleeding scale severity | Randomization to end of study (up to 39 months after randomization of last patient) | This is to assess the incidence and severity of bleeding in each treatment arm |
| Secondary | Number of participants with bleeding events overall and by World Health Organization (WHO) bleeding scale severity | Randomization to end of study (up to 39 months after randomization of last patient) | This is to assess the number and severity of bleeding in each treatment arm |
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.
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/NCT05653349
GET https://conductscience.org/api/trials/v1/NCT05653349/registered?page=2