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

Phase 1

Recruiting

• Conditions: Healthy Volunteers; Systemic Lupus Erythematosus (SLE); Cutaneous Lupus Erythematosus (CLE)
• Interventions: Drug: Placebo; Drug: KK4277

• Registration Number: NCT05411016
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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 administration of KK4277 in patients with Systemic lupus erythematosus (SLE) or Cutaneous lupus erythematosus (CLE).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-08
• Study Start: 2022-07-19
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-06
• Last Update Posted: 2023-08-08
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
KK4277	KK4277	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)	Part 1 : from Day 1 through at most Day 113, Part 2: from Day 1 through at most Day 169	For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are evaluated.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (23)

Fujita Health University Hospital; 🇯🇵 Kutsukake, Aichi, Japan

Japan Community Health care Organization Chukyo Hospital; 🇯🇵 Minami, Aichi, Japan

Juntendo University Urayasu Hospital; 🇯🇵 Urayasu, Chiba, Japan

Kyusyu University Hospital; 🇯🇵 Higashi, Fukuoka, Japan

Kanazawa University Hospital; 🇯🇵 Kanazawa, Ishikawa, 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; 🇯🇵 Nishihara, Okinawa, Japan

Saitama Medical University Hospital; 🇯🇵 Moriyama, Saitama, Japan

Tokyo Medical And Dental University Hospital; 🇯🇵 Bunkyō-Ku, Tokyo, Japan

St. Luke's International Hospital; 🇯🇵 Chuo Ku, Tokyo, Japan

Showa University East Hospital; 🇯🇵 Shinagawa-Ku, Tokyo, Japan

Keio University Hospital; 🇯🇵 Shinjuku-Ku, Tokyo, Japan

Center Hospital of the 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, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of