A Phase 1, open-label, multiple-dose study of KHK4827 in subjects with systemic sclerosis

Phase 1

Completed

• Conditions: systemic sclerosis

• Registration Number: JPRN-jRCT2080223630
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Subject meets the diagnostic criteria defined in the Guidelines for Systemic Sclerosis (Japanese Dermatological Association 2016) at screening.
- Onset of skin phenomenon within 60 months before enrollment
- Moderate to severe systemic sclerosis with a modified Rodnan total skin thickness score (mRSS) of 10 to < 30 and progressive skin thickening at screening and at enrollment.

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) Subject 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) Subject 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) Subject has severe depression based on a total score of >= 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment (note: subjects with a total score of 10 to 14 on the PHQ-8 should be referred to a mental health care professional)

Study & Design

• Study Type: Interventional
• Study Design: Not specified