Systemic SclerosisPhase 2NCT05214794
An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
A Phase 2 study testing nemolizumab in people with Systemic Sclerosis, run by Maruho Co., Ltd. at 1 site in Japan.
Trial summary
To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- nemolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteJapan
- Study dates
- 20 Apr 2022to 30 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Systemic Sclerosis according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria
- Systemic Sclerosis patients with moderate to sever skin sclerosis
Who cannot join
- Patients witg a disease considered inappropriate for participation in clinical trials, such as serious cardiac / hepatic / renal / pulmonary / hematologic disease
- Patients with a diseases that could interfere with assessment of Systemic Sclerosis
- Patients with body weight less than 30.0kg
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.
- Conditions
- Systemic Sclerosis
- Being tested
- nemolizumab
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nemolizumabDrug
nemolizumab will be administered subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| nemolizumab | Experimental | Not described Receives: Drug: nemolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and week 24
Secondary outcomes (11)
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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start20 Apr 2022
- Primary completion4 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maruho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ayumi Yoshizaki, MD, PhD, Principal investigator, Tokyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214794
- Sponsor's protocol ID
- M525101-21
- Status last verified
- Nov 2024
- First submitted
- 17 Jan 2022
- Last updated
- 13 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT05214794
- Acronym / sponsor ID
- M525101-21
- Conditions
- Systemic Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Posted 13 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nemolizumab | Experimental | Drug: nemolizumab |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Systemic Sclerosis according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria
- Systemic Sclerosis patients with moderate to sever skin sclerosis
Key exclusion criteria (4 listed)
- Patients witg a disease considered inappropriate for participation in clinical trials, such as serious cardiac / hepatic / renal / pulmonary / hematologic disease
- Patients with a diseases that could interfere with assessment of Systemic Sclerosis
- Patients with body weight less than 30.0kg
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nemolizumabnemolizumab will be administered subcutaneous injection | Drug | nemolizumab |
Primary outcome
Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 24
Time frame: Baseline and 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
11 secondary outcomes
Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 52
Time frame: From baseline up to Week 52
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24
Time frame: From baseline up to Week 24
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52
Time frame: From baseline up to Week 52
Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 24
Time frame: From baseline up to Week 24
Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 52
Time frame: From baseline up to Week 52
Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 24
Time frame: From baseline up to Week 24
Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 52
Time frame: From baseline up to Week 52
Change From Baseline in Physician's Global Assessment at Week 24
Time frame: From baseline up to Week 24
Change From Baseline in Physician's Global Assessment at Week 52
Time frame: From baseline up to Week 52
Change From Baseline in Patient's Global Assessment at Week 24
Time frame: From baseline up to Week 24
Change From Baseline in Patient's Global Assessment at Week 52
Time frame: From baseline up to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayumi Yoshizaki, MD, PhD principal investigator
Tokyo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nemolizumab in people with Systemic Sclerosis, run by Maruho Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 24 (time frame: Baseline and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.