Evaluating KK4277 in healthy volunteers and lupus patients

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

This study is testing a new drug called KK4277 to see if it's safe for healthy people and those with lupus.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 157 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Kyowa Kirin Co., Ltd. (Industry-sponsored)
• Locations: 23 sites (Kutsukake, Aichi and 22 other locations)
• Trial ID: NCT05411016 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and tolerability of KK4277, administered either intravenously or subcutaneously, in two parts. The first part involves healthy Japanese or non-Asian adult males, while the second part focuses on patients diagnosed with systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE). Participants will receive either KK4277 or a placebo, and the study will monitor their responses to the treatment. The goal is to gather data on the drug's safety profile in both healthy individuals and those with lupus-related conditions.

Who should consider this trial

Good fit: Ideal candidates include healthy males aged 18 to under 50 for Part 1 and adults aged 18 to under 75 with a diagnosis of SLE or CLE for Part 2.

Not a fit: Patients with active lupus nephritis or other significant health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients suffering from systemic and cutaneous lupus erythematosus.

How similar studies have performed: While this study explores a novel approach, similar studies evaluating treatments for lupus have shown varying degrees of success.

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

Where this trial is running

Kutsukake, Aichi and 22 other locations

• Fujita Health University Hospital — Kutsukake, Aichi, Japan (Enrolling_by_invitation)
• Japan Community Health care Organization Chukyo Hospital — Minami, Aichi, Japan (Enrolling_by_invitation)
• Juntendo University Urayasu Hospital — Urayasu, Chiba, Japan (Enrolling_by_invitation)
• Kyusyu University Hospital — Higashi, Fukuoka, Japan (Enrolling_by_invitation)
• Kanazawa University Hospital — Kanazawa, Ishikawa, Japan (Enrolling_by_invitation)
• Yokohama City University Medical Center — Minami, Kanagawa, Japan (Not_yet_recruiting)
• Kitasato University Hospital — Minami, Kanagawa, Japan (Enrolling_by_invitation)
• National University Corporation Tohoku University Tohoku University Hospital — Aoba, Miyagi, Japan (Not_yet_recruiting)
• Niigata University Medical & Dental Hospital — Chuo Ku, Niigata, Japan (Enrolling_by_invitation)
• University of the Ryukyus Hospital — Nishihara, Okinawa, Japan (Enrolling_by_invitation)
• Saitama Medical University Hospital — Moriyama, Saitama, Japan (Not_yet_recruiting)
• Tokyo Medical And Dental University Hospital — Bunkyō-Ku, Tokyo, Japan (Enrolling_by_invitation)
• St. Luke's International Hospital — Chuo Ku, Tokyo, Japan (Enrolling_by_invitation)
• Showa University East Hospital — Shinagawa-Ku, Tokyo, Japan (Recruiting)
• Keio University Hospital — Shinjuku-Ku, Tokyo, Japan (Recruiting)
• Center Hospital of the National Center for Global Health and Medicine — Shinjuku-Ku, Tokyo, Japan (Enrolling_by_invitation)
• Medical Co. LTA Sumida Hospital — Sumida-ku, Tokyo, Japan (Active_not_recruiting)
• Fukushima Medical University Hospital — Fukushima, Japan (Enrolling_by_invitation)
• Nagasaki University Hospital — Nagasaki, Japan (Not_yet_recruiting)
• Juntendo University Nerima Hospital — Tokyo, Japan (Not_yet_recruiting)
• Wakayama Medical University Hospital — Wakayama, Japan (Recruiting)
• Ajou University Hospital — Suwon, Gyeonggi-do, Korea, Republic of (Enrolling_by_invitation)
• Seoul National University Hospital — Seoul, Korea, Republic of (Enrolling_by_invitation)

Study contacts

• Study coordinator: Kyowa Kirin Co., Ltd.

Conditions Healthy Volunteers; Systemic Lupus Erythematosus; Cutaneous Lupus Erythematosus