A Study of KHK4827 in Patients With Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Official title:

A Phase 1, Open-label, Multiple-dose Study of KHK4827 in Subjects With Systemic Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04368403
• Other study ID #: 4827-007
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 6, 2017
• Est. completion date: February 29, 2024

Study information

• Verified date: September 2022
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: February 29, 2024
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Drug:
• KHK4827
210 mg every 2 weeks (Q2W), subcutaneous (SC) injection

Locations

Country	Name	City	State
Japan	The University of Tokyo Hospital	Bunkyo-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum KHK4827 concentration		Pre-dose, Week 1, 2, 4, 8, 12, 16, 22, 24, 36, 48, 52 and every 24 weeks through study completion until 2023.
Secondary	Change in modified Rodnan skin score (mRSS) from baseline	mRSS: scored 0(normal), 1(mild), 2(moderate), or 3(severe) per each site, assessed in 17 different body sites, total score=51	Pre-dose, Week 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and every 8 weeks through study completion until 2023.