Active — Not RecruitingPhase 1

A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus

Japan157 participantsStarted 2022-08-03

Plain-language summary

Part 1 : To evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KK4277 in healthy Japanese or non-Asian adult males. Part 2 : To evaluate the safety and tolerability of repeated IV or SC administration of KK4277 in patients with Systemic lupus erythematosus (SLE) or Cutaneous lupus erythematosus (CLE).

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Patients who meet the EULAR/ACR 2019 SLE classification criteria and have a diagnosis of SLE by screening
✓. Patients with CLE diagnosed by skin biopsy

What they're measuring

Number of participants with adverse events (AEs)

Timeframe: Part 1 : from Day 1 through at most Day 113, Part 2: from Day 1 through at most Day 169

Trial details

NCT IDNCT05411016

SponsorKyowa Kirin Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-10

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