A Study of KW-0761 in Subjects With HTLV-1 Associated Myelopathy (HAM)

NCT ID: NCT03191526

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-22
• Study Completion Date: 2021-08-31

Brief Summary

The objective of this study is to assess the efficacy and safety of KW-0761 after intravenous injections in subjects with HTLV-1 associated myelopathy (HAM) in Japan.

Detailed Description

The effects of KW-0761 (0.3 mg/kg) on the Osame's motor disability score (OMDS) of subjects with HTLV-1 associated myelopathy (HAM).

Conditions

HTLV-1 Associated Myelopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

KW-0761 0.3 mg/kg IV

Intravenous injection every 12 weeks. Duration of double-blind treatment is going to be for 24 weeks and be followed by transitional period, which is for maximal 4 weeks. After that, duration of open label treatment is going to be conducted for 24 weeks. And an extension treatment will be continued until the approval or termination.

Group Type: EXPERIMENTAL

KW-0761 0.3 mg/kg IV

Intervention Type: DRUG

Intravenous injection every 12 weeks.

Placebo (saline)

Intravenous injection every 12 weeks. Duration of double-blind treatment is going to be for 24 weeks and be followed by transitional period, which is for maximal 4 weeks. After that, duration of open label treatment is going to be conducted for 24 weeks. And an extension treatment will be continued until the approval or termination.

Group Type: PLACEBO_COMPARATOR

Placebo (saline)

Intervention Type: DRUG

Intravenous injection every 12 weeks.

Interventions

KW-0761 0.3 mg/kg IV

Intravenous injection every 12 weeks.

Intervention Type: DRUG

Placebo (saline)

Intravenous injection every 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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, Interferon-α, 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)

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nagoya University Hosipital

Nagoya, Aichi-ken, Japan

Ehime University Hospital

Tone, Ehime, Japan

Fukuoka University Hospital

Fukuoka, Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Hospital of the University of Occupational and Environmental Health, Japan

Kitakyushu, Fukuoka, Japan

Kagoshima City Hospital

Kagoshima, Kagoshima-ken, Japan

Kagoshima University Hospital

Kagoshima, Kagoshima-ken, Japan

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, Japan

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Tohoku University Hosipital

Sendai, Miyagi, Japan

Fujimoto General Hospital

Miyakonojō, Miyazaki, Japan

Oita Prefectural Hospital

Ōita, Oita Prefecture, Japan

National Hospital Organization Okinawa National Hospital

Ginowan, Okinawa, Japan

University of the Ryukyus Hospital

Nakagami, Okinawa, Japan

Kansai Medical University Hosipital

Hirakata, Osaka, Japan

University Hosipital, Kyoto Prefectural University of Medicine

Kyoto, , Japan

Countries

Japan

References

Sato T, Nagai M, Watanabe O, Misu T, Takenouchi N, Ohkubo R, Ishihara S, Tsuboi Y, Katsuno M, Nakagawa M, Matsushita T, Aso Y, Matsuura E, Tokashiki T, Mukaino A, Adachi H, Nakanishi K, Yamaguchi Y, Yamaguchi S, Yamano Y. Multicenter, randomized, double-blind, placebo-controlled phase 3 study of mogamulizumab with open-label extension study in a minimum number of patients with human T-cell leukemia virus type-1-associated myelopathy. J Neurol. 2024 Jun;271(6):3471-3485. doi: 10.1007/s00415-024-12239-x. Epub 2024 Mar 2.

Reference Type: DERIVED

PMID: 38430272 (View on PubMed)

Other Identifiers

0761HAM-001

Identifier Type: -

Identifier Source: org_study_id