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

Kyowa Kirin

Status and phase

Enrolling

Phase 1

Conditions

Healthy Volunteers

Cutaneous Lupus Erythematosus (CLE)

Systemic Lupus Erythematosus (SLE)

Treatments

Drug: Placebo

Drug: KK4277

Study type

Interventional

Funder types

Industry

Identifiers

NCT05411016

4277-001

Details and patient eligibility

About

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).

Enrollment

157 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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