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NCT05133531 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment
A Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, sponsored by Regeneron Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 190
- Enrollment target
- 20
- Study locations
NCT05133531 is a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 190 participants, below the 251-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT05133531, a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 190 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is researching a clinical treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on people with paroxysmal nocturnal hemoglobinuria (PNH). The aim of the study is to see how safe and effective the pozelimab + cemdisiran combination is for people with PNH and how the combination compares with 2 existing treatments: ravulizumab and eculizumab. The pozelimab + cemdisiran combination may be referred to as "study drugs". Ravulizumab and eculizumab may also be called the "comparator drug". The study is looking at several research questions, including: * How effective is the pozelimab + cemdisiran combination compared to ravulizumab? * How effective is pozelimab + cemdisiran combination compared to eculizumab? * What side effects may happen from taking the study drugs? * How much study drugs are in the blood at different times? * Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)
Conditions Studied
Interventions
- DRUG Ravulizumab
- DRUG Pozelimab
- DRUG Cemdisiran
- DRUG Eculizumab
Study Locations (20)
Other
- A Beneficencia Portuguesa de Sao Paulo, BP Mirante - São Paulo
- Casa de Saude Santa Marcelina - São Paulo
- George Papanikolaou Hospital - Thessaloniki
- Semmelweis University - Budapest
- Bhagwan Mahaveer Cancer Hospital and Research Centre (BMCHRC) - Jaipur
- Hematology Citta della Salute e della Scienza di Torino - Turin
Kerala
- Malabar Cancer Center, Kerala - Kannur
- Amrita Institute of Medical Sciences (AIMS) and Research Centre Aims - Kochi
Uttar Pradesh
- King George Hospital - Lucknow
- Sanjay Gandhi Postgraduate Institute of Medical Sciences - Lucknow
California
- The Oncology Institute of Hope & Innovation - Whittier
São Paulo
- Centro de Estudos e Pesquisas em Hematologia e Oncologia - Santo André
Ontario
- Toronto General Hospital - Toronto
Beijing Municipality
- Peking Union Medical College Hospital - Beijing
Antioquia
- Hospital Pablo Tobon Uribe - Medellín
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2027-01-28 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05133531
The ClinicalTrials.gov registry entry for NCT05133531 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 251-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (24% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Paroxysmal Nocturnal Hemoglobinuria appearing as the primary indexed condition, and to 4 interventions - of which Ravulizumab is the first listed.
NCT05133531 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, Kerala, Uttar Pradesh.
Frequently Asked Questions
What is clinical trial NCT05133531 about?
NCT05133531 is a clinical study titled "A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment". This study is researching a clinical treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on people with paroxysmal nocturnal hemoglobinuria (PNH). The aim of the study is to see how safe and effective the pozelimab + cemdisiran combination is for p...
What is the current status of trial NCT05133531?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 190 participants. The study started on 2022-08-01. Estimated completion is 2027-01-28.
What conditions does trial NCT05133531 study?
This clinical trial studies the following conditions: Paroxysmal Nocturnal Hemoglobinuria.
What interventions are being tested in trial NCT05133531?
The interventions under investigation include: Ravulizumab (DRUG), Pozelimab (DRUG), Cemdisiran (DRUG), Eculizumab (DRUG).
Who is sponsoring clinical trial NCT05133531?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05133531 being conducted?
This trial has 20 study locations across California, São Paulo, Ontario, Beijing Municipality, Antioquia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
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