Clinical trial NCT01449071: Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)
Official title: A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Pharmacokinetics of One 12 Week Treatment Cycle of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects With Moderate to Severe Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Monoclonal antibody
B-cell immunotherapy
Epratuzumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-10-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of Epratuzumab in Japanese subjects with moderate to severe general SLE as add on to standard of care treatment during the trial.


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

Primary outcomes:
measure: Area under the concentration time curve (AUC)
timeFrame: From baseline to 12 weeks
measure: Half-life (t1/2)
timeFrame: From baseline to 12 weeks
measure: Maximum plasma Concentration (Cmax)
timeFrame: From Baseline to 12 weeks
Secondary outcomes:
measure: Incidence of anti-epratuzumab in plasma during administration over 12 weeks
timeFrame: Day 0 (initial administration day) and week 12 (end of the evaluation period)
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: 09
city: Fukuoka
country: Japan
facility: 10
city: Fukuoka
country: Japan
facility: 11
city: Kitakyushu
country: Japan
facility: 03
city: Tokyo
country: Japan
facility: 01
city: Tokyo
country: Japan
facility: 08
city: Urayasu
country: Japan
facility: 12
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
citation: Tsuru T, Tanaka Y, Kishimoto M, Saito K, Yoshizawa S, Takasaki Y, Miyamura T, Niiro H, Morimoto S, Yamamoto J, Lledo-Garcia R, Shao J, Tatematsu S, Togo O, Koike T. Safety, pharmacokinetics, and pharmacodynamics of epratuzumab in Japanese patients with moderate-to-severe systemic lupus erythematosus: Results from a phase 1/2 randomized study. Mod Rheumatol. 2016;26(1):87-93. doi: 10.3109/14397595.2015.1079292. Epub 2015 Oct 19.