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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03191526
Recruitment Status : Active, not recruiting
First Posted : June 19, 2017
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
HTLV-1 Associated Myelopathy Drug: KW-0761 0.3 mg/kg IV Drug: Placebo (saline) Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Patients With HTLV-1 Associated Myelopathy (HAM)
Actual Study Start Date : May 22, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: 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.
Drug: KW-0761 0.3 mg/kg IV
Intravenous injection every 12 weeks.

Placebo Comparator: 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.
Drug: Placebo (saline)
Intravenous injection every 12 weeks.




Primary Outcome Measures :
  1. Improvement in Osame's motor disability score [ Time Frame: At week 4, 8 and 12 after second injection ]

Secondary Outcome Measures :
  1. HTLV-1 Proviral load in peripheral blood [ Time Frame: Pre-dose, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 weeks post-dose ]
  2. Mean of twice 10 m walking time [ Time Frame: Pre-dose, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 weeks post-dose ]
  3. Modified Ashworth Scale [ Time Frame: Pre-dose, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 weeks post-dose ]
  4. Evaluation of Clinical Global Impression (CGI-I) [ Time Frame: Pre-dose, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 weeks post-dose ]
  5. Evaluation of Clinical Global Impression (VAS) [ Time Frame: Pre-dose, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 weeks post-dose ]
  6. Evaluation of Urinary dysfunction (OABSS) [ Time Frame: Pre-dose, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 weeks post-dose ]
  7. Evaluation of Urinary dysfunction (I-PSS) [ Time Frame: Pre-dose, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 weeks post-dose ]
  8. Evaluation of sensory dysfunction (numbness in the lower limbs (VAS)) [ Time Frame: Pre-dose, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 weeks post-dose ]
  9. Evaluation of sensory dysfunction (Pain in the lower limbs (VAS)) [ Time Frame: Pre-dose, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 weeks post-dose ]
  10. Neopterine Concentration in CSF [ Time Frame: At week 12 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191526


Locations
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Japan
Nagoya University Hosipital
Nagoya, Aichi, Japan
Ehime University Hospital
Tone, Ehime, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka Prefecture, Japan
Kyushu University Hospital
Fukuoka, Fukuoka Prefecture, Japan
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu, Fukuoka, Japan
Kagoshima City Hospital
Kagoshima, Kagoshima Prefecture, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima Prefecture, Japan
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa Prefecture, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto Prefecture, Japan
Tohoku University Hosipital
Sendai, Miyagi Prefecture, Japan
Fujimoto General Hospital
Miyakonojō, Miyazaki, Japan
Oita Prefectural Hospital
Oita, Oita Prefecture, Japan
National Hospital Organization Okinawa National Hospital
Ginowan, Okinawa Prefecture, Japan
University of the Ryukyus Hospital
Nakagami, Okinawa Prefecture, Japan
Kansai Medical University Hosipital
Hirakata, Osaka Prefecture, Japan
University Hosipital, Kyoto Prefectural University of Medicine
Kyoto, Japan
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.

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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT03191526     History of Changes
Other Study ID Numbers: 0761HAM-001
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Paraparesis, Tropical Spastic
Spinal Cord Diseases
Bone Marrow Diseases
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases
HTLV-I Infections
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Mogamulizumab
Antineoplastic Agents