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Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
NCT04119050 · View on ClinicalTrials.gov ↗
Study Summary
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG M281
Study Locations (20)
Florida
- GNP Research — Cooper City
- University of Florida College of Medicine — Gainesville
- 21st Century Oncology — Jacksonville
- Lakes Research — Miami Lakes
- AdventHealth Cancer Institute — Orlando
- Children's Research Institute — St. Petersburg
California
- MemorialCare Medical Group — Fountain Valley
- University of Southern California — Los Angeles
- Compassionate Cancer Care — Riverside
- American Institute of Research — Whittier
New York
- Montefiore Medical Center — Lake Success
- Monter Cancer Center — Lake Success
- Hematology Oncology Associates of Rockland — Nyack
Colorado
- University of Colorado Anschutz Medical Campus — Aurora
Illinois
- Rush University Medical Center — Chicago
Kansas
- Alliance for Multispeciality Research — Merriam
Louisiana
- Tulane University School of Medicine — New Orleans
Michigan
- Henry Ford Medical Center — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2019-08-15 |
| Est. Completion | 2028-04-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04119050
The ClinicalTrials.gov registry entry for NCT04119050 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 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 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: NCT04119050 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, New York. 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 NCT04119050 about?
NCT04119050 is a clinical study titled "Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia". The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
What is the current status of trial NCT04119050?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2019-08-15. Estimated completion is 2028-04-01.
What conditions does trial NCT04119050 study?
This clinical trial studies the following conditions: Warm Autoimmune Hemolytic Anemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04119050?
The interventions under investigation include: Placebo (DRUG), M281 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04119050?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04119050 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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