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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411016
• Other study ID #: 4277-001
• Status: Recruiting
• Phase: Phase 1
• Start date: July 19, 2022
• Est. completion date: March 2025

Study information

• Verified date: August 2023
• Source: Kyowa Kirin Co., Ltd.
• Contact: Kyowa Kirin Co., Ltd.
• Phone: +81-3-5205-7200
• Email: clinical.info.jp[@]kyowakirin.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Lupus Erythematosus (CLE)
• Healthy Volunteers
• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus (SLE)

Intervention

Drug:
• Placebo
Placebo is administered single dose or multiple dose by IV or SC injection
• KK4277
KK4277 is administered single dose or multiple dose by IV or SC injection

Locations

Country	Name	City	State
Japan	Medical Co. LTA Sumida Hospital	Sumida-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to the maximum concentration		Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169
Secondary	The maximum concentration		Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169
Secondary	Area under the concentration-time curve		Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169