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

• Register: ClinicalTrials.gov
• Last refreshed on: 23 September 2024
• Main ID: NCT05411016
• Date of registration: 06/06/2022
• Prospective Registration: Yes
• Primary sponsor: Kyowa Kirin Co., Ltd.
• Public title: A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
• Scientific 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
• Date of first enrolment: August 3, 2022
• Target sample size: 157
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05411016
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Japan, Korea, Republic of

Contacts

• Name: Kyowa Kirin Co., Ltd.

• Name: Jun Kinoshita
• Affiliation: Kyowa Kirin Co., Ltd.

Key inclusion & 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


Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Systemic Lupus Erythematosus (SLE)

Cutaneous Lupus Erythematosus (CLE)

Intervention(s)

Drug: Placebo

Drug: KK4277

Primary Outcome(s)

Number of participants with adverse events (AEs) [Time Frame: Part 1 : from Day 1 through at most Day 113, Part 2: from Day 1 through at most Day 169]

Secondary Outcome(s)

Profile of pharmacokinetics of serum KK4277 concentration [Time Frame: 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]

The maximum concentration [Time Frame: Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169]

Time to the maximum concentration [Time Frame: Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169]

Area under the concentration-time curve [Time Frame: Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169]

Secondary ID(s)

4277-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors