Phase I study to evaluate the safety of crovalimab, the effects of crovalimab on the body, and the processing of crovalimab in participants with lupus nephritis
- Conditions
- upus nephritisSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN12809537
- Lead Sponsor
- F. Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 15
Current participant inclusion criteria as of 27/04/2023:
1. Age 18 - 65 years at the time of signing the Informed Consent Form
2. Body weight =40 kg at screening
3. Active LN, as evidenced by either: 1) A kidney biopsy demonstrating active proliferative (Class III or IV) and/or membranous (Class V) LN, performed within 12 months of screening or during screening; or 2) biopsy-proven Class III, IV, and/or V LN at anytime before screening and an active LN flare, as determined by the investigator, requiring the equivalent of at least 0.5 mg/kg/day of prednisone during screening.
4. UPCR =1.5 g/g on a 24-hour urine collection at screening
5. Vaccination against Neisseria meningitidis (N. meningitidis) serotypes A, C, W, and Y <3 years prior to initiation of study treatment
6. Vaccination against Haemophilus influenzae type B and Streptococcus pneumoniae according to national vaccination recommendations
Previous participant inclusion criteria as of 06/12/2022:
1. Age 18 - 65 years at the time of signing the Informed Consent Form
2. Body weight =40 kg at screening
3. Active LN, as evidenced by a kidney biopsy demonstrating active proliferative (Class III or IV) and/or membranous (Class V) LN, performed within 12 months of screening or during screening
4. UPCR =1.5 g/g on a 24-hour urine collection at screening
5. Vaccination against Neisseria meningitidis (N. meningitidis) serotypes A, C, W, and Y <3 years prior to initiation of study treatment
6. Vaccination against Haemophilus influenzae type B and Streptococcus pneumoniae according to national vaccination recommendations
Previous participant inclusion criteria:
1. Age 18 - 65 years at the time of signing the Informed Consent Form
2. Body weight =40 kg at screening
3. Active LN, as evidenced by a kidney biopsy demonstrating active proliferative (Class III or IV) and/or membranous (Class V) LN, performed within 12 months of screening or during screening
4. UPCR = 1.5 g/g on a 24-hour urine collection at screening
5. Vaccination against Neisseria meningitidis (N. meningitidis) <3 years prior to initiation of study treatment
6. Vaccination against Haemophilus influenzae type B and Streptococcus pneumoniae according to national vaccination recommendations
Current participant exclusion criteria as of 06/12/2022:
1. Pregnant or breastfeeding or intending to become pregnant during the study or within 46 weeks after the final dose of crovalimab or within 6 weeks after the final dose of mycopenolate mofetil (MMF), whichever is longer
2. Severe renal impairment, as defined by estimated glomerular filtration rate < 15 millimetres per minute per 1.73 metres square (mL/min/1.73 m²), need for dialysis or renal transplantation
3. Presence of rapidly-progressive glomerulonephritis
4. Active or evolving multisystem organ dysfunction or failure
5. Known or suspected hereditary complement deficiency
6. History of N. meningitidis infection within 6 months prior to screening and up to the first drug administration
7. History of serious recurrent or chronic infection
8. Known or suspected immune deficiency
9. Positive Human immunodeficiency virus (HIV) test or known HIV infection
10. Splenectomy < 6 months prior to screening
11. Participants who have a history of malignancy within 5 years prior to screening and up to the first dose of study treatment
12. History of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in crovalimab, including hypersensitivity to human, humanized, or murine monoclonal antibodies or known hypersensitivity to any constituent of the product, or to corticosteroids or MMF
13. Current, previous or expected future treatment with a complement inhibitor within 46 weeks after the final crovalimab administration
14. Lack of peripheral venous access
15. Any condition requiring plasmapheresis
Previous participant exclusion criteria:
1. Pregnant or breastfeeding, or intending to become pregnant during the study or within 6 months after the final dose of crovalimab or within 6 weeks after the final dose of mycopenolate mofetil (MMF), whichever is longer
2. Severe renal impairment, as defined by estimated glomerular filtration rate < 15 millimetres per minute per 1.73 metres square (mL/min/1.73 m²), need for dialysis or renal transplantation
3. Presence of rapidly-progressive glomerulonephritis
4. Active or evolving multisystem organ dysfunction or failure
5. Known or suspected hereditary complement deficiency
6. History of N. meningitidis infection within 6 months prior to screening and up to the first drug administration
7. History of serious recurrent or chronic infection
8. Known or suspected immune deficiency
9. Positive Human immunodeficiency virus (HIV) test or known HIV infection
10. Splenectomy < 6 months prior to screening
11. Participants who have a history of malignancy within 5 years prior to screening and up to the first dose of study treatment
12. History of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in crovalimab, including hypersensitivity to human, humanized, or murine monoclonal antibodies or known hypersensitivity to any constituent of the product, or to corticosteroids or MMF
13. Current, previous or expected future treatment with a complement inhibitor within 6 months after the final crovalimab administration
14. Lack of peripheral venous access
15. Any condition requiring plasmapheresis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method