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

Launched by KYOWA KIRIN CO., LTD. · Jun 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called KK4277 to see how safe and well-tolerated it is in both healthy volunteers and patients with certain types of lupus, specifically Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE). The trial is divided into two parts: the first part involves healthy adult men aged 18 to under 50, while the second part focuses on adults aged 18 to under 75 who have been diagnosed with SLE or CLE. Participants will receive either a single dose or multiple doses of KK4277 through an intravenous (IV) line or a subcutaneous (under the skin) injection.

To join the trial, healthy volunteers must be non-Asian males with a specific body mass index (BMI) and no significant health issues, while patients with lupus need to have a confirmed diagnosis and meet certain health criteria. Throughout the study, participants can expect to be closely monitored for their health and any side effects from the treatment. It's important to know that individuals with severe complications from lupus or other serious health problems may not be eligible to participate. This trial aims to gather important information that could help improve treatments for lupus.

Gender

ALL

Eligibility 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