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

NCT05411016 | Active Not Recruiting Phase 1

• 1 other identifier: 4277-001
• Study Type: interventional
• Target: 157
• Locations: 2 countries
• Sites: 23

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)

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events (AEs)

  For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are evaluated.

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

Secondary Outcomes (4)

• Profile of pharmacokinetics of serum KK4277 concentration

  Part 1 : Day 1 (pre-dose, 0, 1, 6 hours after the start of administration), 2, 3, 4, 5, 6, 8, 15, 22, 29, 43, 57, 71, 85, 99, 113, Part 2 :Enrollment, Day1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 141, 169

• Time to the maximum concentration

  Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169

• The maximum concentration

  Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169

• Area under the concentration-time curve

  Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

KK4277

EXPERIMENTAL

Drug: KK4277

Interventions

Placebo DRUG

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

Placebo

KK4277 DRUG

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

KK4277

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (23)

Fujita Health University Hospital

Kutsukake, Aichi-ken, 470-1192, Japan

Location

Japan Community Health care Organization Chukyo Hospital

Minami, Aichi-ken, 457-8510, Japan

Location

Juntendo University Urayasu Hospital

Urayasu, Chiba, 279-0021, Japan

Location

Kyusyu University Hospital

Higashi, Fukuoka, 812-8582, Japan

Location

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Yokohama City University Medical Center

Minami, Kanagawa, 232-0024, Japan

Location

Kitasato University Hospital

Minami, Kanagawa, 252-0375, Japan

Location

National University Corporation Tohoku University Tohoku University Hospital

Aoba, Miyagi, 980-8574, Japan

Location

Niigata University Medical & Dental Hospital

Chuo Ku, Niigata, 951-8520, Japan

Location

University of the Ryukyus Hospital

Ginowan, Okinawa, 901-2725, Japan

Location

Saitama Medical University Hospital

Moriyama, Saitama, 350-0495, Japan

Location

Institute of Science Tokyo Hospital

Bunkyō-Ku, Tokyo, 113-8519, Japan

Location

St. Luke's International Hospital

Chuo Ku, Tokyo, 104-8560, Japan

Location

Showa Medical University East Hospital

Shinagawa-Ku, Tokyo, 142-0054, Japan

Location

Keio University Hospital

Shinjuku-Ku, Tokyo, 160-8582, Japan

Location

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

Shinjuku-Ku, Tokyo, 162-8655, Japan

Location

Medical Co. LTA Sumida Hospital

Sumida-ku, Tokyo, 130-0004, Japan

Location

Fukushima Medical University Hospital

Fukushima, 960-1295, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

Juntendo University Nerima Hospital

Tokyo, 177-8521, Japan

Location

Wakayama Medical University Hospital

Wakayama, 641-8510, Japan

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases

Study Officials

• Jun Kinoshita

  Kyowa Kirin Co., Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor: pharmacokinetic person, pharmacodynamic analysis person and investigational drug administration person are unblinded.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 8, 2022
• Study Start: August 3, 2022
• Primary Completion: December 10, 2024
• Study Completion: December 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (21); KR (2)