A Phase 3 Study of KHK4827 in Patients With Systemic Sclerosis

NCT ID: NCT03957681

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-23
• Study Completion Date: 2025-04-11

Brief Summary

To evaluate the efficacy and safety of KHK4827 in patients with systemic sclerosis who have moderate to severe skin thickening

Conditions

Moderate to Severe Systemic Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

KHK4827

Group Type: EXPERIMENTAL

KHK4827

Intervention Type: DRUG

210 mg Q2W, SC

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Q2W, SC

Interventions

KHK4827

210 mg Q2W, SC

Intervention Type: DRUG

Placebo

Q2W, SC

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)
• Myocartial 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 (%FVC < 60% and %DLco < 40%, calculated according to the Reference Values for Spirometry, Including Viral Capacity, in Japanese Adults Calcluated 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

Chukyo Hospital

Nagoya, Aichi-ken, Japan

The University of Tokyo Hospital

Tokyo, Bunkyo-ku, Japan

The University of Fukui Hospital

Yoshida-gun, Fukui, Japan

St. Marianna University School of Medecine Hospital

Kawasaki, Kanagawa, Japan

Osaka University Hospital

Suita, Osaka, Japan

Fukushima Medical University Hospital

Fukushima, , Japan

Countries

Japan

Other Identifiers

4827-008

Identifier Type: -

Identifier Source: org_study_id