臨床研究等提出・公開システム

A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Subjects with HTLV-1 Associated Myelopathy (HAM)

A Phase 3 Study of KW-0761 in Subjects with HTLV-1 Associated Myelopathy (HAM)

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

clinical.info.jp@kyowakirin.com

completed

June. 15, 2017

Interventional

Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study

treatment purpose

3

1) Voluntary written informed consent to participate in the study
2) Diagnosis as HAM according to the second edition of HAM Treatment Manual
3) At least 1-year history of HAM
4) Ongoing medication*1 for HAM, with no changes in 3 months before enrollment; or inadequate response or intolerance to prior medication,*2 which must have been discontinued for at least 3 months before enrollment. Subjects on maintenance therapy with steroids must have been receiving =< 10 mg/day prednisolone equivalent continuously for at least 3 months before enrollment.
*1 Steroids, salazosulfapyridine, or >= 1.5 g/day vitamin C
*2 Steroids, IFN-alpha, salazosulfapyridine, or >= 1.5 g/day vitamin C
5) No change in the degree of motor dysfunction for at least 3 months before the date of screening, as judged by the investigator or subinvestigator
6) A OMDS of >=3 at screening and able to walk >= 10 m at screening (use of a single cane or double canes is allowed)

1) Any of the following significant concomitant diseases:
Type 1 diabetes mellitus, Poorly controlled type 2 diabetes mellitus (HbA1c (NGSP) > 8.5%), Congestive heart failure (Class II to IV of the New York Heart Association Functional Classification), Myocardial infarction within 1 year before enrollment, Unstable angina within 1 year before enrollment, Poorly controlled hypertension (systolic blood pressure > 150 mm Hg and diastolic blood pressure > 90 mm Hg at screening), Sever chronic lung disease requiring oxygen therapy, Multiple sclerosis or any other demyelinating disease, Epilepsy requiring treatment with antiepileptics (with the exception of epilepsy controlled by antiepileptics, with no occurrence of seizures for at least 3 years before informed consent), and Active malignancy (including ATL); or onset of malignancy or previous treatment for malignancy (with the exception of resected or surgically cured intraepithelial carcinoma of the uterine cervix, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or ductal breast carcinoma) within 5 years before informed consent
2) Active infection
3) Concurrent spinal cord compression lesion (e.g., cervical spine diseases, disk herniation, or ossification of the ligamentum flavum) , with the exception of conditions that would not affect efficacy evaluation in the study, as judged by the investigator or subinvestigator
4) Concurrent dementia
5) Concurrent psychiatric disorder, with the exception of conditions that would not affect obtaining informed consent or efficacy evaluation in the study, as judged by the investigator or subinvestigator
6) History of or current alcohol or drug dependence
7) Planned surgery during the study period
8) Any other conditions unsuitable for participation in the study in the opinion of the investigator or subinvestigator

Both

HTLV-1 associated Myelopathy (HAM)

investigational material(s)
Generic name etc : KW-0761
INN of investigational material : Mogamulizumab
Therapeutic category code : 625 Anti-virus agents
Dosage and Administration for Investigational material : 0.3 mg/kg, IV

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

efficacy
Improvement in Osame's motor disability score

efficacy
- HTLV-1 proviral load and 10 m walking time at each measuring point
- Evaluation of muscle spasticity (Modified Ashworth Scale)
- Evaluation of Clinical Global Impression (CGI-I, VAS)
- Evaluation of Urinary dysfunction (OABSS, I-PSS)
- Evaluation of sensory dysfunction (numbness in the lower limbs (VAS), Pain in the lower limbs (VAS))
- Neopterine Concentration in CSF
safety
Adverse events

May. 22, 2017