Clinical trial NCT05411016: A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Systemic Lupus Erythematosus (SLE)
Cutaneous Lupus Erythematosus (CLE)
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-08
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 or SC administration of KK4277 in patients with Systemic lupus erythematosus (SLE) or Cutaneous lupus erythematosus (CLE).


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

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Part 1 : from Day 1 through at most Day 113, Part 2: from Day 1 through at most Day 169
Secondary outcomes:
measure: Profile of pharmacokinetics of serum KK4277 concentration
timeFrame: 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
measure: Time to the maximum concentration
timeFrame: Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169
measure: The maximum concentration
timeFrame: Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169
measure: Area under the concentration-time curve
timeFrame: Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169
Other outcomes:
Locations:
city: Kutsukake
country: Japan
facility: Fujita Health University Hospital
state: Aichi
city: Minami
country: Japan
facility: Japan Community Health care Organization Chukyo Hospital
state: Aichi
city: Urayasu
country: Japan
facility: Juntendo University Urayasu Hospital
state: Chiba
city: Higashi
country: Japan
facility: Kyusyu University Hospital
state: Fukuoka
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Minami
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Minami
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Aoba
country: Japan
facility: National University Corporation Tohoku University Tohoku University Hospital
state: Miyagi
city: Chuo Ku
country: Japan
facility: Niigata University Medical & Dental Hospital
state: Niigata
city: Nishihara
country: Japan
facility: University of the Ryukyus Hospital
state: Okinawa
city: Moriyama
country: Japan
facility: Saitama Medical University Hospital
state: Saitama
city: Bunkyō-Ku
country: Japan
facility: Tokyo Medical And Dental University Hospital
state: Tokyo
city: Chuo Ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Shinagawa-Ku
country: Japan
facility: Showa University East Hospital
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
state: Tokyo
city: Sumida-ku
country: Japan
facility: Medical Co. LTA Sumida Hospital
state: Tokyo
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Tokyo
country: Japan
facility: Juntendo University Nerima Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Kyowa Kirin Co., Ltd.
name: Jun Kinoshita
role: STUDY_CHAIR
References: