A Phase 3 Study of KHK4827 in Patients With Systemic Sclerosis

NCT03957681 | Completed Phase 3

• 1 other identifier: 4827-008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

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

Keywords

systemic sclerosis; brodalumab; KHK4827

Outcome Measures

Primary Outcomes (1)

• 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

  at least 2 weeks up to 24 weeks

Secondary Outcomes (1)

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

  at least 2 weeks up to 52 weeks

Study Arms (2)

KHK4827

EXPERIMENTAL

Drug: KHK4827

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

KHK4827 DRUG

210 mg Q2W, SC

KHK4827

Placebo DRUG

Q2W, SC

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (6)

Chukyo Hospital

Nagoya, Aichi-ken, 457-8510, Japan

Location

The University of Tokyo Hospital

Tokyo, Bunkyo-ku, 113-8655, Japan

Location

The University of Fukui Hospital

Yoshida-gun, Fukui, 910-1193, Japan

Location

St. Marianna University School of Medecine Hospital

Kawasaki, Kanagawa, 216-8511, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Fukushima Medical University Hospital

Fukushima, 960-1295, Japan

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 21, 2019
• Study Start: May 23, 2019
• Primary Completion: October 16, 2020
• Study Completion: April 11, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

JP (6)