NCT04368403CompletedPhase 1
A Study of KHK4827 in Patients With Systemic Sclerosis
A Phase 1, Open-label, Multiple-dose Study of KHK4827 in Subjects With Systemic Sclerosis
Source: ClinicalTrials.gov · Last updated 11 Jul 2025
Brief summary (registry, in English)
Exploratory evaluation of pharmacokinetics and safety of KHK4827 in subjects with systemic sclerosis
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 13 Apr 2020
- Start date
- 6 Oct 2017
- Primary completion date
- 31 Jan 2019
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT04368403
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 8
- From 6 Oct 2017 to the primary completion date, 31 Jan 2019
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Tokyo Hospital Coordinator of this site? Confirm its status | Bunkyō-Ku | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.