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

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose or Multiple Ascending Dose Study of KK4277 in Healthy Volunteers, Patient With Systemic Lupus Erythematosus, and Patient With Cutaneous Lupus Erythematosus

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Volunteers; Systemic Lupus Erythematosus (SLE); Cutaneous Lupus Erythematosus (CLE)
• Intervention / Treatment: Drug: Placebo; Drug: KK4277

• Study Type: Interventional
• Enrollment (Estimated): 157
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukushima, Japan, 960-1295
    • Fukushima Medical University Hospital
  • Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital
  • Tokyo, Japan, 177-8521
    • Juntendo University Nerima Hospital
  • Wakayama, Japan, 641-8510
    • Wakayama Medical University Hospital
  • Aichi-ken
    • Kutsukake, Aichi-ken, Japan, 470-1192
      • Fujita Health University Hospital
    • Minami, Aichi-ken, Japan, 457-8510
      • Japan Community Health Care Organization Chukyo Hospital
  • Chiba
    • Urayasu, Chiba, Japan, 279-0021
      • Juntendo University Urayasu Hospital
  • Fukuoka
    • Higashi, Fukuoka, Japan, 812-8582
      • Kyusyu University Hospital
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan, 920-8641
      • Kanazawa University Hospital
  • Kanagawa
    • Minami, Kanagawa, Japan, 232-0024
      • Yokohama City University Medical Center
    • Minami, Kanagawa, Japan, 252-0375
      • Kitasato University Hospital
  • Miyagi
    • Aoba, Miyagi, Japan, 980-8574
      • National University Corporation Tohoku University Tohoku University Hospital
  • Niigata
    • Chuo Ku, Niigata, Japan, 951-8520
      • Niigata University Medical & Dental Hospital
  • Okinawa
    • Ginowan, Okinawa, Japan, 901-2725
      • University of the Ryukyus Hospital
  • Saitama
    • Moriyama, Saitama, Japan, 350-0495
      • Saitama Medical University Hospital
  • Tokyo
    • Bunkyō-Ku, Tokyo, Japan, 113-8519
      • Institute of Science Tokyo Hospital
    • Chuo Ku, Tokyo, Japan, 104-8560
      • St. Luke's International Hospital
    • Shinagawa-Ku, Tokyo, Japan, 142-0054
      • Showa Medical University East Hospital
    • Shinjuku-Ku, Tokyo, Japan, 160-8582
      • Keio University Hospital
    • Shinjuku-Ku, Tokyo, Japan, 162-8655
      • Japan Institute for Health Security National Center for Global Health and Medicine
    • Sumida-ku, Tokyo, Japan, 130-0004
      • Medical Co. LTA Sumida Hospital
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, South Korea, 16499
      • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: Part 1

• 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

Inclusion Criteria: Part 2

• 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: Part 1

• 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

Exclusion Criteria:Part2

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo is administered single dose or multiple dose by IV or SC injection
Experimental: KK4277	Drug: KK4277; KK4277 is administered single dose or multiple dose by IV or SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.
• Investigators: Study Chair: Jun Kinoshita, Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Actual): December 10, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 4277-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No