What Is Crovalimab?
Crovalimab is a drug currently under investigation in clinical trials. The provided trial descriptions indicate that it is administered through either intravenous (IV) infusion or subcutaneous (SC) injection. The specific way Crovalimab works in the body (its mechanism of action) is not detailed in the available trial information. It is being studied for its potential to treat several conditions, primarily focusing on certain blood disorders and autoimmune diseases.
Hoffmann-La Roche is the sole sponsor for all 10 clinical trials involving Crovalimab. These studies have collectively enrolled a total of 759 participants. The first trial began on 2017-05-17, and the latest study is projected to conclude on 2025-09-15. To date, 2 trials have been completed, and there are currently no trials actively recruiting new participants for Crovalimab studies.
Uses and Conditions Under Study
Crovalimab is being investigated for its potential to treat several serious medical conditions. The majority of studies focus on blood disorders and conditions affecting the immune system.
- Paroxysmal Nocturnal Hemoglobinuria (PNH): This rare, life-threatening blood disorder is characterized by the destruction of red blood cells. Crovalimab is being studied for its potential to manage symptoms and prevent complications associated with PNH. A total of 4 trials are investigating Crovalimab for PNH, including those listed as Paroxysmal Hemoglobinuria, Nocturnal.
- Atypical Hemolytic Uremic Syndrome (aHUS): aHUS is a rare genetic disease that causes abnormal blood clots to form in small blood vessels throughout the body, leading to kidney failure and other serious problems. Crovalimab is being explored as a potential treatment to help regulate the immune system's complement pathway, which is often overactive in aHUS. 2 trials are studying Crovalimab for aHUS.
- Sickle Cell Disease: This inherited blood disorder affects red blood cells, causing them to become rigid and sickle-shaped, which can block blood flow and lead to pain and organ damage. Crovalimab is being investigated in 2 trials for its potential role in managing aspects of sickle cell disease.
- Antiphospholipid Syndrome: This autoimmune disorder causes the immune system to mistakenly attack normal proteins in the blood, leading to blood clots in arteries and veins. Crovalimab is being studied in 1 trial for its potential to address the immune dysregulation seen in this syndrome.
- Guillain-Barré Syndrome: A rare disorder where the body's immune system attacks its nerves, leading to muscle weakness and sometimes paralysis. Crovalimab is being investigated in 1 trial for its potential to modulate the immune response in patients with Guillain-Barré Syndrome.
Dosing
Crovalimab has been studied in various dosage forms and administration schedules. It is administered either intravenously (IV) or subcutaneously (SC). The dosage often varies based on the participant's body weight.
Investigational dosages described in trials include:
- For participants weighing between 40 kilograms (kg) and less than 100 kg:
- An initial IV dose of 1000 mg.
- Followed by SC injections of 340 mg on specific days (e.g., Day 2, Weeks 2, 3, and 4).
- Maintenance SC doses of 680 mg every 4 weeks (Q4W) from Week 5 onwards.
- For participants weighing 100 kg or more:
- An initial IV dose of 1500 mg.
- Followed by SC injections of 340 mg on specific days (e.g., Day 2, Weeks 2, 3, and 4).
- Maintenance SC doses of 680 mg every 4 weeks (Q4W) from Week 5 onwards.
Some trials also explore different weekly or bi-weekly subcutaneous dosing schedules, such as Crovalimab administered QW (weekly), Q2W (every two weeks), or Q4W (every four weeks) for PNH participants. Specific dosage forms studied include Crovalimab alone, or Crovalimab in combination with Vitamin K Antagonists (VKA).
Side Effects
Information regarding the specific side effects of Crovalimab from the provided clinical trial data is not available.
Clinical Trial Results
Crovalimab for Paroxysmal Nocturnal Hemoglobinuria (PNH)
In a study (NCT04434092) comparing Crovalimab to Eculizumab in participants with PNH who had not previously received complement inhibitors, several key outcomes were assessed:
- Hemolysis Control: Hemolysis control, measured by lactate dehydrogenase (LDH) levels, was achieved in 79.3% of participants treated with Crovalimab, which was comparable to 79.0% of those receiving Eculizumab.
- Breakthrough Hemolysis (BTH): Breakthrough hemolysis occurred in 10.4% of participants on Crovalimab, compared to 14.5% of those on Eculizumab.
- Free Hemoglobin: Crovalimab treatment generally led to a reduction in free hemoglobin levels, with most participants experiencing decreases ranging from approximately -431.50 mg/L to -367.86 mg/L. One participant, however, saw an increase of 474.88 mg/L. Similarly, Eculizumab treatment typically resulted in free hemoglobin reductions, ranging from about -421.14 mg/L to -328.56 mg/L, with one participant experiencing an increase of 495.69 mg/L. A decrease in free hemoglobin indicates less red blood cell destruction.
- Fatigue: Participants treated with Crovalimab experienced an average increase in their Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score, indicating improved fatigue, with mean changes of 7.79 and 36.02. Participants on Eculizumab also saw improvements, with mean changes of 5.15 and 35.09.
Another study (NCT04654468) evaluated Crovalimab in participants with PNH who had not previously received complement inhibition:
- Transfusion Avoidance: The percentage of participants who avoided transfusions from baseline through week 25, compared to the 24 weeks prior to screening, showed a difference of 50.98%.
- Hemolysis Control: The mean percentage of participants achieving hemolysis control was 78.66%.
- Stabilized Hemoglobin: Hemoglobin stabilization was observed in 51.0% of participants.
- Free Hemoglobin: Participants experienced a mean percent change from baseline in free hemoglobin of -45.6180%, indicating a significant reduction.
- Haptoglobin: Haptoglobin levels, which typically increase when red blood cell destruction is reduced, showed a mean percent change from baseline of 295.1351%.
- Fatigue: Fatigue, as assessed by a scale, showed improvements with mean score changes ranging from 6.67 to 31.77.
Currently Recruiting Trials
Based on the latest available information, there are currently no clinical trials for Crovalimab actively recruiting new participants. This means that at this time, no new volunteers are being sought for studies involving this investigational treatment.
Where to Participate
As there are no Crovalimab clinical trials currently recruiting, there are no active sites seeking participants at this time. When trials are active, participation is typically open to individuals of all genders. It is important to note that these trials generally do not enroll healthy volunteers, focusing instead on patients with specific medical conditions. While specific age ranges can vary by study, general eligibility for Crovalimab trials has typically not included children.
Development Timeline
The journey of Crovalimab in clinical development began on May 17, 2017, with its first trial. Since then, Hoffmann-La Roche has been the sole sponsor, driving the research across 10 total trials involving 759 participants. Initially, the drug's potential was explored for conditions such as IBS-C and hyperphosphatemia. Over time, the development pipeline significantly expanded to address a broader range of serious conditions.
This expansion included studies for Sickle Cell Disease, Antiphospholipid Syndrome, Guillain-Barré Syndrome, and Paroxysmal Nocturnal Hemoglobinuria. The development has progressed steadily through various phases, with a strong focus on later-stage research. Out of the ten trials conducted, six have reached Phase 3, indicating advanced stages of investigation, alongside two Phase 2 trials, one Phase 1 trial, and one Phase 1/Phase 2 study. The latest trial is projected to conclude by September 15, 2025, marking continued commitment to understanding Crovalimab's full potential.