Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)
Launched by UCB PHARMA · Oct 6, 2011
Trial Information
Current as of May 23, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Positive Anti-nuclear Antibody (ANA) at Screening (Visit 1)
- • Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria
- • Active moderate to severe SLE activity as demonstrated by British Isles Lupus Assessment Group Index (BILAG)
- • Active moderate to severe SLE disease as demonstrated by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score on stable SLE treatment
- Exclusion Criteria:
- • Subjects who are breastfeeding, pregnant, or plan to become pregnant
- • Subjects with active, severe SLE disease activity which involves the renal system and active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A
- • Serious infections
About Ucb Pharma
UCB Pharma is a global biopharmaceutical company dedicated to discovering and delivering innovative treatments for severe diseases in neurology and immunology. With a strong focus on research and development, UCB leverages cutting-edge science and technology to advance its pipeline of therapies aimed at improving the quality of life for patients. Committed to collaboration and patient-centricity, UCB engages with healthcare professionals and patient communities to ensure its clinical trials address unmet medical needs and contribute to the advancement of healthcare solutions worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Fukuoka, , Japan
Fukuoka, , Japan
Fukuoka, , Japan
Kitakyushu, , Japan
Tokyo, , Japan
Tokyo, , Japan
Urayasu, , Japan
Patients applied
Trial Officials
UCB Clinical Trial Call Center
Study Director
+1 877 822 9493 (UCB)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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