A Study of E6011 in Japanese Subjects With Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: E6011

• Registration Number: NCT02196558
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

This study consist of treatment phase (12 weeks) and extension phase (40 weeks). This study is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate mainly the safety and tolerability of 12-week repeated subcutaneous administration of E6011 in Japanese subjects with Rheumatoid Arthritis. First 12 subjects will enroll as 100 mg group, next 12 subjects will enroll as 200 mg group, and last 9 subjects will enroll as 400 mg group. A total of 33 subjects will receive repeated subcutaneous administration of E6011. Subjects who roll over onto the Extension phase will have continued monitoring until 52 weeks after the initial administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-26
• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-22
• Primary Completion: 2016-08-12
• Study Completion: 2017-07-13
• Status Verified: 2017-08
• Results First Submitted: 2020-07-29
• Results First Submitted QC: 2020-07-29
• Last Update Submitted: 2020-07-29
• Results First Posted: 2020-08-13
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E6011, 100 mg Arm	E6011	E6011 will be administered repeatedly, subcutaneously at Week 0, 1, 2, followed by every 2 weeks upto 10 weeks (treatment phase).100 mg group will receive E6011 subcutaneously, 1 ml. If a subject intends to continue administrations; the subject will receive a total of 20 subsequent biweekly administrations (40 weeks) at stable dose (Extension phase).
E6011, 400 mg Arm	E6011	E6011 will be administered repeatedly, subcutaneously at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks (treatment phase). 400 mg group will receive E6011 subcutaneously, 1 ml each at four sites or 2 ml each at two sites. If a subject intends to continue administrations, the subject will receive a total of 20 subsequent biweekly administrations (40 weeks) at stable dose (Extension Phase).
E6011, 200 mg Arm	E6011	E6011 will be administered repeatedly, subcutaneously at Week 0, 1, 2, followed by every 2 weeks upto 10 weeks (treatment phase). 200 mg group will receive E6011 subcutaneously, 1 ml each at two sites. If a subject intends to continue administrations; the subject will receive a total of 20 subsequent biweekly administrations (40 weeks) at stable dose (Extension phase).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Up to 52 Weeks

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Positive Anti-E6011 Antibodies Results	Up to 52 weeks
Serum Concentrations of E6011	At Week 0 (predose), Week 1, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (postdose)