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New lupus drug candidate enters first human tests

NCT ID NCT05411016

Disease control Sponsor: Kyowa Kirin Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage study tests a new drug called KK4277 in healthy volunteers and people with lupus (SLE or CLE). The main goal is to check safety and how the body processes the drug. It is too early to know if it works, but results will guide future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KK4277
What this could lead to
If safe, this could pave the way for larger studies testing whether KK4277 helps control lupus symptoms.
What could go wrong
This is a very early Phase 1 trial focused only on safety and dosing. It is too small and early to know if KK4277 works for lupus, and many early-stage drugs fail.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 157 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cutaneous lupus erythematosus systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cutaneous lupus erythematosus (CLE) Healthy volunteers Systemic lupus erythematosus (SLE)

Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Fujita Health University Hospital

    Kutsukake, Aichi-ken, 470-1192, Japan

  • Fukushima Medical University Hospital

    Fukushima, 960-1295, Japan

  • Institute of Science Tokyo Hospital

    Bunkyō-Ku, Tokyo, 113-8519, Japan

  • Japan Community Health care Organization Chukyo Hospital

    Minami, Aichi-ken, 457-8510, Japan

  • Japan Institute for Health Security National Center for Global Health and Medicine

    Shinjuku-Ku, Tokyo, 162-8655, Japan

  • Juntendo University Nerima Hospital

    Tokyo, 177-8521, Japan

  • Juntendo University Urayasu Hospital

    Urayasu, Chiba, 279-0021, Japan

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Keio University Hospital

    Shinjuku-Ku, Tokyo, 160-8582, Japan

  • Kitasato University Hospital

    Minami, Kanagawa, 252-0375, Japan

  • Kyusyu University Hospital

    Higashi, Fukuoka, 812-8582, Japan

  • Medical Co. LTA Sumida Hospital

    Sumida-ku, Tokyo, 130-0004, Japan

  • Nagasaki University Hospital

    Nagasaki, 852-8501, Japan

  • National University Corporation Tohoku University Tohoku University Hospital

    Aoba, Miyagi, 980-8574, Japan

  • Niigata University Medical & Dental Hospital

    Chuo Ku, Niigata, 951-8520, Japan

  • Saitama Medical University Hospital

    Moriyama, Saitama, 350-0495, Japan

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Showa Medical University East Hospital

    Shinagawa-Ku, Tokyo, 142-0054, Japan

  • St. Luke's International Hospital

    Chuo Ku, Tokyo, 104-8560, Japan

  • University of the Ryukyus Hospital

    Ginowan, Okinawa, 901-2725, Japan

  • Wakayama Medical University Hospital

    Wakayama, 641-8510, Japan

  • Yokohama City University Medical Center

    Minami, Kanagawa, 232-0024, Japan

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