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A Phase 3 Study of KHK4827 in Patients With Systemic Sclerosis

Primary Purpose

Moderate to Severe Systemic Sclerosis

Status

Active

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

KHK4827

Placebo

About this trial

This is an interventional treatment trial for Moderate to Severe 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:

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
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

Sites / Locations

Chukyo Hospital
The University of Tokyo Hospital
The University of Fukui Hospital
St. Marianna University School of Medecine Hospital
Osaka University Hospital
Fukushima Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

KHK4827

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in modified Rodnan skin score (mRSS) from baseline at Week 24

mRSS: scored 0(normal), 1(mild), 2(moderate), or 3(severe) per each site, assessed in 17 different body sites, total score=51

Secondary Outcome Measures

Change in modified Rodnan skin score (mRSS) from baseline at Week 52

Full Information

NCT ID

NCT03957681

First Posted

May 16, 2019

Last Updated

February 13, 2023

Sponsor

Kyowa Kirin Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03957681

Brief Title

A Phase 3 Study of KHK4827 in Patients With Systemic Sclerosis

Official Title

A Phase 3, Placebo-controlled, Double-blind Comparative Study of KHK4827 With an Open-label Extension Period in Subjects With Systemic Sclerosis Who Have Moderate to Severe Skin Thickening

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 23, 2019 (Actual)

Primary Completion Date

October 16, 2020 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Moderate to Severe Systemic Sclerosis

Keywords

systemic sclerosis, brodalumab, KHK4827

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

KHK4827

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

KHK4827

Intervention Description

210 mg Q2W, SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Q2W, SC

Primary Outcome Measure Information:

Title

Change in modified Rodnan skin score (mRSS) from baseline at Week 24

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

at least 2 weeks up to 24 weeks

Secondary Outcome Measure Information:

Title

Change in modified Rodnan skin score (mRSS) from baseline at Week 52

Time Frame

at least 2 weeks up to 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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) 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 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

Chukyo Hospital

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

457-8510

Country

Japan

Facility Name

The University of Tokyo Hospital

City

Tokyo

State/Province

Bunkyo-ku

ZIP/Postal Code

113-8655

Country

Japan

Facility Name

The University of Fukui Hospital

City

Yoshida-gun

State/Province

Fukui

ZIP/Postal Code

910-1193

Country

Japan

Facility Name

St. Marianna University School of Medecine Hospital

City

Kawasaki

State/Province

Kanagawa

ZIP/Postal Code

216-8511

Country

Japan

Facility Name

Osaka University Hospital

City

Suita

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Fukushima Medical University Hospital

City

Fukushima

ZIP/Postal Code

960-1295

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

A Phase 3 Study of KHK4827 in Patients With Systemic Sclerosis

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