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A Study of KHK4827 in Patients With Systemic Sclerosis

Primary Purpose

Systemic Sclerosis

Status
Active
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
KHK4827
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring systemic sclerosis, brodalumab, KHK4827

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Tokyo Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KHK4827

Arm Description

Outcomes

Primary Outcome Measures

serum KHK4827 concentration

Secondary Outcome Measures

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

Full Information

First Posted
April 13, 2020
Last Updated
February 13, 2023
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04368403
Brief Title
A Study of KHK4827 in Patients With Systemic Sclerosis
Official Title
A Phase 1, Open-label, Multiple-dose Study of KHK4827 in Subjects With Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 6, 2017 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
Keywords
systemic sclerosis, brodalumab, KHK4827

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KHK4827
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KHK4827
Intervention Description
210 mg every 2 weeks (Q2W), subcutaneous (SC) injection
Primary Outcome Measure Information:
Title
serum KHK4827 concentration
Time Frame
Pre-dose, Week 1, 2, 4, 8, 12, 16, 22, 24, 36, 48, 52 and every 24 weeks through study completion until 2023.
Secondary Outcome Measure Information:
Title
Change in modified Rodnan skin score (mRSS) from baseline
Description
mRSS: scored 0(normal), 1(mild), 2(moderate), or 3(severe) per each site, assessed in 17 different body sites, total score=51
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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: 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 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 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 Patient has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment
Facility Information:
Facility Name
The University of Tokyo Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study of KHK4827 in Patients With Systemic Sclerosis

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