Back to resultsA Study of E6011 in Japanese Subjects With Rheumatoid Arthritis
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
E6011
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Rheumatoid Arthritis, Japanese subjects
Eligibility Criteria
Inclusion Criteria
Subjects must meet all of the following criteria to be included in this study:
- Japanese patients aged 20 to 64 years old at the time of informed consent.
- Diagnosed with rheumatoid arthritis (RA) who meet the 1987 ACR or 2010 ACR/EULAR criteria.
- Presenting tenderness in more than 4 joints (out of 68) and swelling in more than 4 joints (out of 66) at Screening and Observation phase.
- Never been treated with non-anti-TNF biologics or never been treated with 2 or more anti-TNF agents.
- Subjects with greater than or equal to 0.6 mg/dL of high-sensitivity CRP (hs-CRP) level or greater than or equal to 28 mm/hr of erythrocyte sedimentation rate (ESR) at Screening.
- Weighs greater than or equal to 30 kg and less than or equal to 100 kg at Screening.
- Consent to use contraception (both the subject and the subject's partner), for at least 70 days after the last dose of study medication starting on the day of informed consent, if the subject is a man capable of reproduction or a woman of childbearing potential.
- Has voluntarily consented, in writing, to participate in this study
- Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with all aspects of the protocol.
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from this study:
- Any history or complication of inflammatory arthritic disorder other than rheumatoid arthritis or Sjogren's syndrome.
- Meet Class 4 with the Steinbrocker functional classification.
- History or current clinical condition, or associated complications of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease.
- Immunodeficiency or history of HIV infection
- Infection requiring hospitalization or intravenous administration of antibiotics within 4 weeks before the first dose of study treatment, or an infection requiring oral antibiotics within 2 weeks before the first dose of study treatment.
- History of tuberculosis or current complication of active tuberculosis.
- History of severe allergy (shock, or anaphylactoid symptoms).
- History of clinically important vascular edema, hematemesis, hemorrhagic stool, or hemoptysis.
- History of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis obliterans.
- History of clinically important vasculitis (such as mononeuritis multiplex).
- Tested positive for any of the following at Screening: human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (HBs antibody), hepatitis B virus core antibody (HBc antibody), hepatitis B virus DNA (HBV DNA), hepatitis C virus antibody (HCV antibody), human T-lymphotrophic virus Type I antibody (HTLV-1 antibody), or syphilis.
- Any result other than negative in tuberculosis test (T-SPOT.TB Test or QuantiFERON TB Gold Test) at Screening.
- Findings indicating a history of tuberculosis on chest X-ray at Screening.
- Ineligible to participate in the study in the opinion of the investigator or sub investigator.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
E6011, 100 mg Arm
E6011, 200 mg Arm
E6011, 400 mg Arm
Arm Description
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 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).
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).
Outcomes
Primary Outcome Measures
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Secondary Outcome Measures
Number of Participants With Positive Anti-E6011 Antibodies Results
Serum Concentrations of E6011
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02196558
Brief Title
A Study of E6011 in Japanese Subjects With Rheumatoid Arthritis
Official Title
A Phase 1/2 Study of Repeated Subcutaneous E6011 Administration in Japanese Subjects With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 26, 2014 (Actual)
Primary Completion Date
August 12, 2016 (Actual)
Study Completion Date
July 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Rheumatoid Arthritis, Japanese subjects
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E6011, 100 mg Arm
Arm Type
Experimental
Arm Description
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).
Arm Title
E6011, 200 mg Arm
Arm Type
Experimental
Arm Description
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).
Arm Title
E6011, 400 mg Arm
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
E6011
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame
Up to 52 Weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Positive Anti-E6011 Antibodies Results
Time Frame
Up to 52 weeks
Title
Serum Concentrations of E6011
Time Frame
At Week 0 (predose), Week 1, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (postdose)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Subjects must meet all of the following criteria to be included in this study:
Japanese patients aged 20 to 64 years old at the time of informed consent.
Diagnosed with rheumatoid arthritis (RA) who meet the 1987 ACR or 2010 ACR/EULAR criteria.
Presenting tenderness in more than 4 joints (out of 68) and swelling in more than 4 joints (out of 66) at Screening and Observation phase.
Never been treated with non-anti-TNF biologics or never been treated with 2 or more anti-TNF agents.
Subjects with greater than or equal to 0.6 mg/dL of high-sensitivity CRP (hs-CRP) level or greater than or equal to 28 mm/hr of erythrocyte sedimentation rate (ESR) at Screening.
Weighs greater than or equal to 30 kg and less than or equal to 100 kg at Screening.
Consent to use contraception (both the subject and the subject's partner), for at least 70 days after the last dose of study medication starting on the day of informed consent, if the subject is a man capable of reproduction or a woman of childbearing potential.
Has voluntarily consented, in writing, to participate in this study
Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with all aspects of the protocol.
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from this study:
Any history or complication of inflammatory arthritic disorder other than rheumatoid arthritis or Sjogren's syndrome.
Meet Class 4 with the Steinbrocker functional classification.
History or current clinical condition, or associated complications of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease.
Immunodeficiency or history of HIV infection
Infection requiring hospitalization or intravenous administration of antibiotics within 4 weeks before the first dose of study treatment, or an infection requiring oral antibiotics within 2 weeks before the first dose of study treatment.
History of tuberculosis or current complication of active tuberculosis.
History of severe allergy (shock, or anaphylactoid symptoms).
History of clinically important vascular edema, hematemesis, hemorrhagic stool, or hemoptysis.
History of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis obliterans.
History of clinically important vasculitis (such as mononeuritis multiplex).
Tested positive for any of the following at Screening: human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (HBs antibody), hepatitis B virus core antibody (HBc antibody), hepatitis B virus DNA (HBV DNA), hepatitis C virus antibody (HCV antibody), human T-lymphotrophic virus Type I antibody (HTLV-1 antibody), or syphilis.
Any result other than negative in tuberculosis test (T-SPOT.TB Test or QuantiFERON TB Gold Test) at Screening.
Findings indicating a history of tuberculosis on chest X-ray at Screening.
Ineligible to participate in the study in the opinion of the investigator or sub investigator.
Facility Information:
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Kakogawa
State/Province
Hyogo
Country
Japan
City
Kato
State/Province
Hyogo
Country
Japan
City
Kahoku-gun
State/Province
Ishikawa
Country
Japan
City
Yokohama
State/Province
Kanagawa
Country
Japan
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
City
Chuo-Ku
State/Province
Tokyo
Country
Japan
City
Meguro-Ku
State/Province
Tokyo
Country
Japan
City
Ota-Ku
State/Province
Tokyo
Country
Japan
City
Shinjuku-Ku
State/Province
Tokyo
Country
Japan
City
Miyazaki
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
28681650
Citation
Tanaka Y, Takeuchi T, Umehara H, Nanki T, Yasuda N, Tago F, Kawakubo M, Kitahara Y, Hojo S, Kawano T, Imai T. Safety, pharmacokinetics, and efficacy of E6011, an antifractalkine monoclonal antibody, in a first-in-patient phase 1/2 study on rheumatoid arthritis. Mod Rheumatol. 2018 Jan;28(1):58-65. doi: 10.1080/14397595.2017.1337056. Epub 2017 Jul 6.
Results Reference
derived
Learn more about this trial
A Study of E6011 in Japanese Subjects With Rheumatoid Arthritis
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