Phase 1b/2 Study of DS-7011a in Patients with Systemic Lupus Erythematosus (SLE)

JRCT ID: jRCT2031230588

Registered date:23/01/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Systemic Lupus Erythematosus (SLE)
• Date of first enrollment: 12/06/2024
• Target sample size: 24
• Countries of recruitment: United States,Japan,Macedonia,Japan,China,Japan
• Study type: Interventional
• Intervention(s): 20 mg/kg, Intravenous infusions every 4 weeks (Weeks 0, 4, and 8)

Outcome(s)

• Primary Outcome: safety and tolerability
• Secondary Outcome: pharmacokinetics, efficacy and immunogenicity properties

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Inoguchi Akihiro
• Secondary ID(s): NCT05638802