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ACTIVE NOT RECRUITING Phase 3

A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia

NCT05648968 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 90 participants
Start Date 2022-12-30
Est. Completion 2028-12-19
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05648968

The ClinicalTrials.gov registry entry for NCT05648968 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05648968 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Michigan, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05648968?

The interventions under investigation include: Placebo (DRUG), Ianalumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05648968?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial