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

NCT ID: NCT05411016

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-03
• Study Completion Date: 2025-12-31

Brief 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).

Conditions

Healthy Volunteers; Systemic Lupus Erythematosus (SLE); Cutaneous Lupus Erythematosus (CLE)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo is administered single dose or multiple dose by IV or SC injection

KK4277

Group Type: EXPERIMENTAL

KK4277

Intervention Type: DRUG

KK4277 is administered single dose or multiple dose by IV or SC injection

Interventions

Placebo

Placebo is administered single dose or multiple dose by IV or SC injection

Intervention Type: DRUG

KK4277

KK4277 is administered single dose or multiple dose by IV or SC injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Voluntary written informed consent to participate in the study
• Japanese or non-Asian healthy men 18 to < 50 years at the time of informed consent
• BMI 18.5 to < 30.0 at screening

• Voluntary written informed consent to participate in the study
• Age 18 years to < 75 years at the time of informed consent
• Weight over 40 kg and BMI 18.5 to < 35.0 at screening
• Patients who meet any of the following criteria

1. Patients who meet the EULAR/ACR 2019 SLE classification criteria and have a diagnosis of SLE by screening

2. Patients with CLE diagnosed by skin biopsy

Exclusion Criteria

• Current illness requiring treatment
• History of or current respiratory disease, heart disease, gastrointestinal disease, kidney disease, liver disease, psychiatric disease, autoimmune disease, or Cancer.
• History or of current drug allergy

• Complications of active lupus nephritis(urinary column (granular column or red blood cell column), hematuria (>5 red blood cells/high power field, excluding other causes such as stones or infection), proteinuria >0.5 g/24 h, pyuria (>5 white blood cells/high power field excluding infection)) or active central nervous lupus (delirium, psychiatric symptoms, seizures, etc.)
• Patients with serious complications that are judged by the investigator or sub-investigator to affect the conduct and evaluation of the study.
• Patients with bacterial, viral, fungal, or parasitic infections recognized within 28 days prior to obtaining consent
• Patients with an infectious disease requiring hospitalization or IV administration of antimicrobial, antiviral, antifungal, or antiparasitic drugs within 24 weeks prior to obtaining consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Kinoshita

Role: STUDY_CHAIR

Kyowa Kirin Co., Ltd.

Locations

Fujita Health University Hospital

Kutsukake, Aichi-ken, Japan

Japan Community Health care Organization Chukyo Hospital

Minami, Aichi-ken, Japan

Juntendo University Urayasu Hospital

Urayasu, Chiba, Japan

Kyusyu University Hospital

Higashi, Fukuoka, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Yokohama City University Medical Center

Minami, Kanagawa, Japan

Kitasato University Hospital

Minami, Kanagawa, Japan

National University Corporation Tohoku University Tohoku University Hospital

Aoba, Miyagi, Japan

Niigata University Medical & Dental Hospital

Chuo Ku, Niigata, Japan

University of the Ryukyus Hospital

Ginowan, Okinawa, Japan

Saitama Medical University Hospital

Moriyama, Saitama, Japan

Institute of Science Tokyo Hospital

Bunkyō-Ku, Tokyo, Japan

St. Luke's International Hospital

Chuo Ku, Tokyo, Japan

Showa Medical University East Hospital

Shinagawa-Ku, Tokyo, Japan

Keio University Hospital

Shinjuku-Ku, Tokyo, Japan

Japan Institute for Health Security National Center for Global Health and Medicine

Shinjuku-Ku, Tokyo, Japan

Medical Co. LTA Sumida Hospital

Sumida-ku, Tokyo, Japan

Fukushima Medical University Hospital

Fukushima, , Japan

Nagasaki University Hospital

Nagasaki, , Japan

Juntendo University Nerima Hospital

Tokyo, , Japan

Wakayama Medical University Hospital

Wakayama, , Japan

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, , South Korea

Countries

Japan; South Korea

Other Identifiers

4277-001

Identifier Type: -

Identifier Source: org_study_id