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To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nemolizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nemolizumab | Drug | nemolizumab will be administered subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 24 | Compare pre- and post-treatment total mRSS at Week 24. The investigator assessed the degree of skin thickening for each of 17 sites (fingers of both hands, dorsum of both hands, both forearms, both upper arms, face, anterior chest, abdomen, both thighs, both lower legs, and dorsum of both feet) with a 4-point scale from 0 to 3; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness. The total mRSS is the sum of the mRSS of 17 site | Baseline and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 52 | Compare pre- and post-treatment total mRSS at Week 52. The investigator assessed the degree of skin thickening for each of 17 sites (fingers of both hands, dorsum of both hands, both forearms, both upper arms, face, anterior chest, abdomen, both thighs, both lower legs, and dorsum of both feet) with a 4-point scale from 0 to 3; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness. The total mRSS is the sum of the mRSS of 17 site |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayumi Yoshizaki, MD, PhD | Tokyo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Tokyo Hospital | Tokyo | Japan |
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The study was conducted at one site in Japan from April 2022 to July 2024
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| ID | Title | Description |
|---|---|---|
| FG000 | Nemolizumab | Nemolizumab (60mg) was administered subcutaneously every 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
FAS population included all participants who were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nemolizumab | nemolizumab: nemolizumab will be administered subcutaneous injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 24 | Compare pre- and post-treatment total mRSS at Week 24. The investigator assessed the degree of skin thickening for each of 17 sites (fingers of both hands, dorsum of both hands, both forearms, both upper arms, face, anterior chest, abdomen, both thighs, both lower legs, and dorsum of both feet) with a 4-point scale from 0 to 3; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness. The total mRSS is the sum of the mRSS of 17 site | FAS population included all participants who were enrolled. | Posted | Median | Full Range | scores on scale | Baseline and week 24 |
|
From baseline up to Week 52
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nemolizumab | nemolizumab: nemolizumab will be administered subcutaneous injection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA/J ver. 24.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maruho Co.,Ltd. Kyoto R&D Center | Clinical Development Dept. | +81-75-325-3255 | ctinfo@mii.maruho.co.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2023 | Oct 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000612881 | nemolizumab |
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| From baseline up to Week 52 |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 | Compare pre- and post-treatment HAQ-DI at Week 24. The HAQ is a questionnaire that patients with chronic diseases answer themselves to assess physical function related to activities of daily living. The questionnaire consists of 20 questions divided into eight categories (dressing and grooming, standing, eating, walking, hygiene, movement, grip strength, and others), which are rated on a four-point scale from 0 to 3. 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. The highest value in each category is the index for that category, and the average of these is the HAQ-DI. The higher the HAQ-DI, the greater the degree of functional impairment. | From baseline up to Week 24 |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52 | Compare pre- and post-treatment HAQ-DI at Week 52. The HAQ is a questionnaire that patients with chronic diseases answer themselves to assess physical function related to activities of daily living. The questionnaire consists of 20 questions divided into eight categories (dressing and grooming, standing, eating, walking, hygiene, movement, grip strength, and others), which are rated on a four-point scale from 0 to 3. 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. The highest value in each category is the index for that category, and the average of these is the HAQ-DI. The higher the HAQ-DI, the greater the degree of functional impairment. | From baseline up to Week 52 |
| Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 24 | Compare pre- and post-treatment %FVC at Week 24. %FVC is the ratio of the actual measured FVC to the predicted FVC (predicted based on gender, age, and height). | From baseline up to Week 24 |
| Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 52 | Compare pre- and post-treatment %FVC at Week 52. %FVC is the ratio of the actual measured FVC to the predicted FVC (predicted based on gender, age, and height). | From baseline up to Week 52 |
| Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 24 | Compare pre- and post-treatment %DLco at Week 24. Pulmonary diffusion capacity refers to the ability to supply gases such as oxygen from alveoli to the alveolar capillaries. DLco is measured for carbon monoxide (CO) and is expressed as the volume (mL) of CO that transfers from alveolar air to the blood per minute per 1mmHg of alveolar partial pressure. %DLco is the ratio of the actual measured DLco to the predicted DLco (predicated based on age, sex, and height) | From baseline up to Week 24 |
| Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 52 | Compare pre- and post-treatment %DLco at Week 52. Pulmonary diffusion capacity refers to the ability to supply gases such as oxygen from alveoli to the alveolar capillaries. DLco is measured for carbon monoxide (CO) and is expressed as the volume (mL) of CO that transfers from alveolar air to the blood per minute per 1mmHg of alveolar partial pressure. %DLco is the ratio of the actual measured DLco to the predicted DLco (predicated based on age, sex, and height) | From baseline up to Week 52 |
| Change From Baseline in Physician's Global Assessment at Week 24 | Compare pre- and post-treatment physician's global assessment at Week 24. Physician's global assessment is a visual analogue scale in which the attending physician assess the condition of systemic sclerosis based on severity, damage, and overall disease status. 0 is the best condition and 10 is the worst condition. | From baseline up to Week 24 |
| Change From Baseline in Physician's Global Assessment at Week 52 | Compare pre- and post-treatment physician's global assessment at Week 52. Physician's global assessment is a visual analogue scale in which the attending physician assess the condition of systemic sclerosis based on severity, damage, and overall disease status. 0 is the best condition and 10 is the worst condition. | From baseline up to Week 52 |
| Change From Baseline in Patient's Global Assessment at Week 24 | Compare pre- and post-treatment patient's global assessment at Week 24. Patient's Global Assessment is a visual analogue scale in which patients rate their systemic sclerosis condition, with 0 being the best and 10 being the worst. | From baseline up to Week 24 |
| Change From Baseline in Patient's Global Assessment at Week 52 | Compare pre- and post-treatment patient's global assessment at Week 52. Patient's Global Assessment is a visual analogue scale in which patients rate their systemic sclerosis condition, with 0 being the best and 10 being the worst. | From baseline up to Week 52 |
| Participants |
|
| Age, Continuous | Median | Full Range | year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Classification of Primary Disease | Count of Participants | Participants |
|
| Modified Rodnan Total Skin Thickness Score (Total mRSS) | The mRSS is used to assess the severity of skin thickness. The investigator assessed the degree of skin thickening for each of 17 sites (fingers of both hands, dorsum of both hands, both forearms, both upper arms, face, anterior chest, abdomen, both thighs, both lower legs, and dorsum of both feet) with a 4-point scale from 0 to 3; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness. The total mRSS is the sum of the mRSS of 17 sites and ranges from 0 to 51. A higher total mRSS indicates a more severity of skin thickening. | Median | Full Range | scores on scale |
|
| percent forced vital capacity (%FVC) | Forced vital capacity (FVC) is a pulmonary function test that measures the amount of air a participant can forcefully exhale after taking a maximal breath. %FVC is the ratio of the actual measured FVC to the predicted FVC (predicted based on gender, age, and height), with a value of 80% or higher being normal. | Median | Full Range | percentage of actual to predicted FCV |
|
| percent diffusing capacity of lung for carbon monoxide (% DLco) | Pulmonary diffusion capacity refers to the ability to supply gases such as oxygen from alveoli to the alveolar capillaries. DLco is measured for carbon monoxide (CO) and is expressed as the volume (mL) of CO that transfers from alveolar air to the blood per minute per 1mmHg of alveolar partial pressure. %DLco is the ratio of the actual measured DLco to the predicted DLco (predicated based on age, sex, and height), with a normal range of 80% to 120%. | Median | Full Range | percentage of actual to predicted DLco |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 52 | Compare pre- and post-treatment total mRSS at Week 52. The investigator assessed the degree of skin thickening for each of 17 sites (fingers of both hands, dorsum of both hands, both forearms, both upper arms, face, anterior chest, abdomen, both thighs, both lower legs, and dorsum of both feet) with a 4-point scale from 0 to 3; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness. The total mRSS is the sum of the mRSS of 17 site | FAS population included all participants who were enrolled. | Posted | Median | Full Range | scores on scale | From baseline up to Week 52 |
|
|
|
| Secondary | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 | Compare pre- and post-treatment HAQ-DI at Week 24. The HAQ is a questionnaire that patients with chronic diseases answer themselves to assess physical function related to activities of daily living. The questionnaire consists of 20 questions divided into eight categories (dressing and grooming, standing, eating, walking, hygiene, movement, grip strength, and others), which are rated on a four-point scale from 0 to 3. 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. The highest value in each category is the index for that category, and the average of these is the HAQ-DI. The higher the HAQ-DI, the greater the degree of functional impairment. | FAS population included all participants who were enrolled. | Posted | Median | Full Range | scores on scale | From baseline up to Week 24 |
|
|
|
| Secondary | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52 | Compare pre- and post-treatment HAQ-DI at Week 52. The HAQ is a questionnaire that patients with chronic diseases answer themselves to assess physical function related to activities of daily living. The questionnaire consists of 20 questions divided into eight categories (dressing and grooming, standing, eating, walking, hygiene, movement, grip strength, and others), which are rated on a four-point scale from 0 to 3. 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. The highest value in each category is the index for that category, and the average of these is the HAQ-DI. The higher the HAQ-DI, the greater the degree of functional impairment. | FAS population included all participants who were enrolled. | Posted | Median | Full Range | scores on scale | From baseline up to Week 52 |
|
|
|
| Secondary | Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 24 | Compare pre- and post-treatment %FVC at Week 24. %FVC is the ratio of the actual measured FVC to the predicted FVC (predicted based on gender, age, and height). | FAS population included all participants who were enrolled. | Posted | Median | Full Range | percentage of actual to predicted FCV | From baseline up to Week 24 |
|
|
|
| Secondary | Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 52 | Compare pre- and post-treatment %FVC at Week 52. %FVC is the ratio of the actual measured FVC to the predicted FVC (predicted based on gender, age, and height). | FAS population included all participants who were enrolled. | Posted | Median | Full Range | percentage of actual to predicted FCV | From baseline up to Week 52 |
|
|
|
| Secondary | Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 24 | Compare pre- and post-treatment %DLco at Week 24. Pulmonary diffusion capacity refers to the ability to supply gases such as oxygen from alveoli to the alveolar capillaries. DLco is measured for carbon monoxide (CO) and is expressed as the volume (mL) of CO that transfers from alveolar air to the blood per minute per 1mmHg of alveolar partial pressure. %DLco is the ratio of the actual measured DLco to the predicted DLco (predicated based on age, sex, and height) | FAS population included all participants who were enrolled. | Posted | Median | Full Range | percentage of actual to predicted DLco | From baseline up to Week 24 |
|
|
|
| Secondary | Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 52 | Compare pre- and post-treatment %DLco at Week 52. Pulmonary diffusion capacity refers to the ability to supply gases such as oxygen from alveoli to the alveolar capillaries. DLco is measured for carbon monoxide (CO) and is expressed as the volume (mL) of CO that transfers from alveolar air to the blood per minute per 1mmHg of alveolar partial pressure. %DLco is the ratio of the actual measured DLco to the predicted DLco (predicated based on age, sex, and height) | FAS population included all participants who were enrolled. | Posted | Median | Full Range | percentage of actual to predicted DLco | From baseline up to Week 52 |
|
|
|
| Secondary | Change From Baseline in Physician's Global Assessment at Week 24 | Compare pre- and post-treatment physician's global assessment at Week 24. Physician's global assessment is a visual analogue scale in which the attending physician assess the condition of systemic sclerosis based on severity, damage, and overall disease status. 0 is the best condition and 10 is the worst condition. | FAS population included all participants who were enrolled. | Posted | Median | Full Range | scores on scale | From baseline up to Week 24 |
|
|
|
| Secondary | Change From Baseline in Physician's Global Assessment at Week 52 | Compare pre- and post-treatment physician's global assessment at Week 52. Physician's global assessment is a visual analogue scale in which the attending physician assess the condition of systemic sclerosis based on severity, damage, and overall disease status. 0 is the best condition and 10 is the worst condition. | FAS population included all participants who were enrolled. | Posted | Median | Full Range | scores on scale | From baseline up to Week 52 |
|
|
|
| Secondary | Change From Baseline in Patient's Global Assessment at Week 24 | Compare pre- and post-treatment patient's global assessment at Week 24. Patient's Global Assessment is a visual analogue scale in which patients rate their systemic sclerosis condition, with 0 being the best and 10 being the worst. | FAS population included all participants who were enrolled. | Posted | Median | Full Range | scores on scale | From baseline up to Week 24 |
|
|
|
| Secondary | Change From Baseline in Patient's Global Assessment at Week 52 | Compare pre- and post-treatment patient's global assessment at Week 52. Patient's Global Assessment is a visual analogue scale in which patients rate their systemic sclerosis condition, with 0 being the best and 10 being the worst. | FAS population included all participants who were enrolled. | Posted | Median | Full Range | scores on scale | From baseline up to Week 52 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| Adenoviral conjunctivitis | Infections and infestations | MedDRA/J ver. 24.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA/J ver. 24.1 | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA/J ver. 24.1 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA/J ver. 24.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA/J ver. 24.1 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA/J ver. 24.1 | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA/J ver. 24.1 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA/J ver. 24.1 | Non-systematic Assessment |
|
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA/J ver. 24.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA/J ver. 24.1 | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA/J ver. 24.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA/J ver. 24.1 | Non-systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA/J ver. 24.1 | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA/J ver. 24.1 | Non-systematic Assessment |
|
If the PI intends to disclose information obtained through the clinical trial to external parties such as academic societies, prior approval from the Sponsor is required. The Sponsor must not unreasonably withhold such approval. There is no time limit imposed on the Sponsor for granting prior approval.