A Study of KHK4827 in Patients With Systemic Sclerosis

NCT ID: NCT04368403

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-06
• Study Completion Date: 2025-03-31

Brief Summary

Exploratory evaluation of pharmacokinetics and safety of KHK4827 in subjects with systemic sclerosis

Conditions

Systemic Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KHK4827

Group Type: EXPERIMENTAL

KHK4827

Intervention Type: DRUG

210 mg every 2 weeks (Q2W), subcutaneous (SC) injection

Interventions

KHK4827

210 mg every 2 weeks (Q2W), subcutaneous (SC) injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject meets the criteria for diagnosis of the Diagnostic Criteria, Severity Classification, and Clinical Practice Guidelines for Systemic Sclerosis （Japanese Dermatological Association 2016） at the pre-examination
• Subject presented the first symptoms of sclerosis other than Raynaud's phenomenon within 60 months before enrollment
• Subject who has systemic sclerosis accompanied by moderate to severe skin thickening with an mRSS of 10 to <30 at the pre-examination and who has progressing skin thickening

Exclusion Criteria

1. Any of the following significant concomitant diseases:

• Type 1 diabetes
• Poorly controlled type 2 diabetes (HbA1c > 8.5%)
• Congestive heart failure (Class II to IV of the New York Heart Association Functional Classification)
• Myocardial infarction, unstable angina, or stroke occurring within 12 months before the first dose of investigational product
• Poorly controlled hypertension (systolic pressure > 150 mm Hg or diastolic pressure > 90 mg Hg at screening)
• Severe chronic lung disease (%Forced Vital Capacity (FVC) < 60% and %Diffusing capacity of lung for carbon monoxide (DLco) < 40%, calculated according to the Reference Values for Spirometry, Including Viral Capacity, in Japanese Adults Calculated with the LMS Method and Compared with Previous Values [Japanese Respiratory Society])
• Major chronic inflammatory diseases or connective tissue diseases other than scleroderma

2. Patient has a history or evidence of a psychiatric disorder, alcohol and/or substance abuse, or any other mental health disorder that, in the opinion of the investigators, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion

3. Patient has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at enrollment

4. Patient has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

Countries

Japan

References

Fukasawa T, Yoshizaki A, Ebata S, Fukayama M, Kuzumi A, Norimatsu Y, Matsuda KM, Kotani H, Sumida H, Yoshizaki-Ogawa A, Kagebayashi H, Sato S. Interleukin-17 pathway inhibition with brodalumab in early systemic sclerosis: Analysis of a single-arm, open-label, phase 1 trial. J Am Acad Dermatol. 2023 Aug;89(2):366-369. doi: 10.1016/j.jaad.2023.02.061. Epub 2023 Mar 29. No abstract available.

Reference Type: DERIVED

PMID: 36997069 (View on PubMed)

Other Identifiers

4827-007

Identifier Type: -

Identifier Source: org_study_id