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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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23 April 2024 |
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Main ID: |
JPRN-jRCT2031230588 |
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Date of registration:
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23/01/2024 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase 1b/2 Study of DS-7011a in Patients with Systemic Lupus Erythematosus (SLE)
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Scientific title:
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A Phase 1b/2, Double-Blind, Placebo-Controlled, Randomized, Parallel-Arm Study to Explore the Safety, Pharmacokinetics, and Proof of Biological Activity of DS-7011a in Patients with Systemic Lupus Erythematosus |
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Date of first enrolment:
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01/05/2024 |
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Target sample size:
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24 |
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Recruitment status: |
Pending |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCT2031230588 |
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Study type:
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Interventional |
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Study design:
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randomized controlled trial, double blind, placebo control, parallel assignment, treatment purpose
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Phase:
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1-2
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Countries of recruitment
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China
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Japan
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Macedonia
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United States
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Contacts
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Name:
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Contact for Clinical Trial Information |
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Address:
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1-2-58, Hiromachi, Shinagawa-ku, Tokyo
140-8710
Tokyo
Japan |
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Telephone:
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+81-3-6225-1111 |
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Email:
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dsclinicaltrial@daiichisankyo.co.jp |
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Affiliation:
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Daiichi Sankyo Co., Ltd. |
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Name:
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Akihiro
Inoguchi |
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Address:
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1-2-58, Hiromachi, Shinagawa-ku, Tokyo
140-8710
Tokyo
Japan |
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Telephone:
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+81-3-6225-1111 |
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Email:
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dsclinicaltrial@daiichisankyo.co.jp |
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Affiliation:
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Daiichi Sankyo Co., Ltd. |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Male and female subjects must be of 18 years or more with definite SLE for at least 6 months prior to Screening, defined according to the 2019 European League Against Rheumatism (EULAR)/ American College of Rheumatology (ACR) classification criteria for SLE3, including documented history of positivity for antinuclear antibody (titer >=1:80).
- Body mass index (BMI) >=18 kg/m^2 and body weight >=45 kg.
- Presence of active CLE (acute, subacute, and chronic cutaneous lupus) with active skin involvement and a CLASI-A score of 4 or higher at the time of Screening and randomization, as recognized by 2 adjudicators, despite adequate use of conventional therapies (either topical corticosteroids or antimalarial agents used for at least 12 weeks prior to Screening) or because of the requirement to discontinue these therapies due to side effects or poor tolerability.
- Subjects must be willing to have skin tape harvests collected from the affected skin area (skin tape stripping done on the target lesion).
- Subjects must be vaccinated against COVID-19.
Exclusion criteria: - Active LN on induction therapy, or induction therapy completed within 12 weeks prior to Screening.
- Active neuropsychiatric SLE.
- Primary diagnosis of autoimmune or rheumatic disease other than SLE or drug-induced lupus.
- History of chronic, recurrent or recent serious infection, including viral infections, as determined by the investigator, or requiring anti-infective treatment within 12 weeks prior to Screening.
- History of severe herpes infection or signs of herpes or varicella zoster viral infection within 12 weeks prior to Screening.
- Positive COVID-19 molecular (polymerase chain reaction [PCR]) test at Screening or symptoms suggestive of SARS-CoV-2 infection or close contact with an individual with SARS-CoV-2 infection within 2 weeks prior to randomization.
Age minimum:
>= 18age old
Age maximum:
Not applicable
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus (SLE)
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Intervention(s)
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20 mg/kg, Intravenous infusions every 4 weeks (Weeks 0, 4, and 8)
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Primary Outcome(s)
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safety and tolerability
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Secondary Outcome(s)
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pharmacokinetics, efficacy and immunogenicity properties
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Source(s) of Monetary Support
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Ethics review
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Status:
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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