Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01262365
• Date of registration: 14/12/2010
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus EMBODY1
• Scientific title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease
• Date of first enrolment: December 2010
• Target sample size: 793
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01262365
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, Brazil, Bulgaria, Czech Republic, Czechia, Estonia, France, Germany, India, Israel, Italy, Korea, Republic of, Lithuania, Mexico, Puerto Rico, Romania, Russian Federation, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: UCb Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

Inclusion Criteria:

- Positive antinuclear antibodies (ANA) at Screening (Visit 1)

- Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College
of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met

- Active moderate to severe SLE activity as demonstrated by the British Isles Lupus
Assessment Group Index (BILAG)

- Active moderate to severe SLE disease as demonstrated by SLEDAI total score.

- On stable SLE treatment regimen, including mandatory corticosteroids and
immunosuppressants or antimalarials

Exclusion Criteria:

- Subjects who are breastfeeding, pregnant, or plan to become pregnant

- Subjects with active, severe SLE disease activity which involves the renal system

- Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric
element scoring BILAG level A disease.

- Subjects with the evidence of an immunosuppressive state

- Subjects who, in the opinion of the investigator, are at a particularly high risk of
significant infection

- History of malignant cancer, except the following treated cancers: cervical carcinoma
in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.

- Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit
1).

- Subjects with history of infections, including but not limited to concurrent acute or
chronic viral hepatitis B or C

- Subjects with substance abuse or dependence or other relevant concurrent medical
condition

- Subjects with history of thromboembolic events within 1 year of screening Visit.

- Subjects with significant hematologic abnormalities

- Subject has received treatment with other anti- B cell antibodies within 12 months
prior to screening (visit 1)

- Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs
(NSAIDs) within 12 weeks prior to screening (Visit 1)

- Subject has previously participated in this study or has previously received
epratuzumab treatment.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Placebo

Drug: Epratuzumab

Primary Outcome(s)

The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index [Time Frame: At Week 48]

Secondary Outcome(s)

Change From Baseline in Daily Corticosteroid Dose at Week 48 [Time Frame: At Week 48]

The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index [Time Frame: At Week 12]

Change From Baseline in Daily Corticosteroid Dose at Week 24 [Time Frame: At Week 24]

The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index [Time Frame: At Week 24]

The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index [Time Frame: At Week 36]

Secondary ID(s)

2010-018563-41

SL0009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/06/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01262365