臨床研究等提出・公開システム

A Phase 1, open-label, multiple-dose study of KHK4827 in subjects with systemic sclerosis

A Phase 1, open-label, multiple-dose study of KHK4827 in subjects with systemic sclerosis

Kyowa Kirin Co., Ltd.

1-9-2 Otemachi, Chiyoda-ku, Tokyo 100-0004, Japan

clinical.info.jp@kyowakirin.com

Kyowa Kirin Co., Ltd.

1-9-2 Otemachi, Chiyoda-ku, Tokyo 100-0004, Japan

+81-3-5205-7200

clinical.info.jp@kyowakirin.com

completed

Oct. 06, 2017

Interventional

A Phase 1, open-label, multiple-dose study

treatment purpose

1

- Subject meets the diagnostic criteria defined in the Guidelines for Systemic Sclerosis (Japanese Dermatological Association 2016) at screening.
- Onset of skin phenomenon within 60 months before enrollment
- Moderate to severe systemic sclerosis with a modified Rodnan total skin thickness score (mRSS) of 10 to < 30 and progressive skin thickening at screening and at enrollment.

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) Subject 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) Subject 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) Subject has severe depression based on a total score of >= 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment (note: subjects with a total score of 10 to 14 on the PHQ-8 should be referred to a mental health care professional)

Both

systemic sclerosis

investigational material(s)
Generic name etc : KHK4827
INN of investigational material : brodalumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : SC, 210 mg Q2W

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

pharmacokinetics
serum KHK4827 concentration, Pharmacokinetic parameter from week 22 to week 24


safety
Adverse events and side effects, anti-KHK4827 antibodies, C-SSRS, PHQ-8

efficacy
Change of mRSS from the baseline

July. 24, 2017