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NCT05648968 · ClinicalTrials.gov registry record · Phase 3
A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia
A Phase 3 study of Warm Autoimmune Hemolytic Anemia (wAIHA), sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT05648968: Active Phase 3 study of Warm Autoimmune Hemolytic Anemia (wAIHA), sponsored by Novartis Pharmaceuticals.
NCT05648968 is a Phase 3 study of Warm Autoimmune Hemolytic Anemia (wAIHA) that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 90 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05648968, a Phase 3 study of Warm Autoimmune Hemolytic Anemia (wAIHA), is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate efficacy and safety of ianalumab compared to placebo in patients with warm autoimmune hemolytic anemia, who failed at least one line of treatment.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Ianalumab
Study Locations (20)
Other
- Novartis Investigative Site - Caba
- Novartis Investigative Site - Caba
- Novartis Investigative Site - Dalian
- Novartis Investigative Site - Tianjin
- Novartis Investigative Site - Tianjin
- Novartis Investigative Site - Créteil
- Novartis Investigative Site - Lille
- Novartis Investigative Site - Nantes
- Novartis Investigative Site - Nice
- Novartis Investigative Site - Dresden
- Novartis Investigative Site - Essen
- Novartis Investigative Site - Giessen
Michigan
- Michigan Center of Medical Research - Farmington Hills
Minnesota
- University of Minnesota Med Center - Minneapolis
Washington
- Fred Hutchinson Cancer Center - Seattle
Buenos Aires
- Novartis Investigative Site - CABA
Australian Capital Territory
- Novartis Investigative Site - Garran
Victoria
- Novartis Investigative Site - Melbourne
Guangdong
- Novartis Investigative Site - Guangzhou
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2022-12-30 |
| Est. Completion | 2028-12-19 |
| Phase | Phase 3 |
What the registry record for NCT05648968 still lists
NCT05648968 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Warm Autoimmune Hemolytic Anemia (wAIHA) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05648968 names 20 study sites across 9 states, led by Other, Michigan, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05648968 about?
NCT05648968 is a clinical study titled "A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia". The purpose of this study is to evaluate efficacy and safety of ianalumab compared to placebo in patients with warm autoimmune hemolytic anemia, who failed at least one line of treatment.
What is the current status of trial NCT05648968?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2022-12-30. Estimated completion is 2028-12-19.
What conditions does trial NCT05648968 study?
This clinical trial studies the following conditions: Warm Autoimmune Hemolytic Anemia (wAIHA).
What interventions are being tested in trial NCT05648968?
The interventions under investigation include: Placebo (DRUG), Ianalumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05648968?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05648968 being conducted?
This trial has 20 study locations across Michigan, Minnesota, Washington, Buenos Aires, Australian Capital Territory. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Warm Autoimmune Hemolytic Anemia (wAIHA)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05648968's enrollment target sits among peer trials
90 1725th of 2000 higher than 263 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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