Moderate to Severe Systemic Sclerosis Clinical Trial
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
| Verified date | September 2022 |
| Source | Kyowa Kirin Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To evaluate the efficacy and safety of KHK4827 in patients with systemic sclerosis who have moderate to severe skin thickening
| Status | Active, not recruiting |
| Enrollment | 100 |
| Est. completion date | February 29, 2024 |
| Est. primary completion date | October 16, 2020 |
| 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) - 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. 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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Fukushima Medical University Hospital | Fukushima | |
| Japan | St. Marianna University School of Medecine Hospital | Kawasaki | Kanagawa |
| Japan | Chukyo Hospital | Nagoya | Aichi |
| Japan | Osaka University Hospital | Suita | Osaka |
| Japan | The University of Tokyo Hospital | Tokyo | Bunkyo-ku |
| Japan | The University of Fukui Hospital | Yoshida-gun | Fukui |
| Lead Sponsor | Collaborator |
|---|---|
| Kyowa Kirin Co., Ltd. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Change in modified Rodnan skin score (mRSS) from baseline at Week 52 | at least 2 weeks up to 52 weeks |