Clinical Trial

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

Active, Not Recruiting Phase 1
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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).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-06-06; most recent amendment 2025-09-15.
Status change: Recruiting → Active, Not Recruiting 2025-09-15
Status change: Not Yet Recruiting → Recruiting 2023-08-06
Trial Details
NCT Number NCT05411016
Lead Sponsor Kyowa Kirin Co., Ltd.
Conditions Healthy Volunteers, Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
Enrollment 157 participants
Start Date 2022-08-03
Primary Completion 2024-12-10 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-09-19