Trial · NCT05214794
An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
NCT05214794, Phase 2, Completed, Maruho Co., Ltd.; results first posted 2026-02-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis. Trials, record NCT05214794. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05214794
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
- NCT number
- NCT05214794
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Maruho Co., Ltd.
- Conditions
- Systemic Sclerosis
- Interventions
- nemolizumab
- First posted
- 2022-01-31
- Last updated
- 2026-02-13
- Results first posted
- 2026-02-13
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 24 | 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 |
| Secondary | Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 52 | From baseline up to 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 |
| Secondary | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 | From baseline up to 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. |
| Secondary | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52 | From baseline up to 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. |
| Secondary | Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 24 | From baseline up to 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). |
| Secondary | Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 52 | From baseline up to 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). |
| Secondary | Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 24 | From baseline up to 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) |
| Secondary | Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 52 | From baseline up to 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) |
| Secondary | Change From Baseline in Physician's Global Assessment at Week 24 | From baseline up to 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. |
| Secondary | Change From Baseline in Physician's Global Assessment at Week 52 | From baseline up to 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 24 | Baseline and week 24 | FAS population included all participants who were enrolled. | scores on scale | MEDIAN |
| SECONDARY | Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 52 | From baseline up to Week 52 | FAS population included all participants who were enrolled. | scores on scale | MEDIAN |
| SECONDARY | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 | From baseline up to Week 24 | FAS population included all participants who were enrolled. | scores on scale | MEDIAN |
| SECONDARY | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52 | From baseline up to Week 52 | FAS population included all participants who were enrolled. | scores on scale | MEDIAN |
| SECONDARY | Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 24 | From baseline up to Week 24 | FAS population included all participants who were enrolled. | percentage of actual to predicted FCV | MEDIAN |
| SECONDARY | Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 52 | From baseline up to Week 52 | FAS population included all participants who were enrolled. | percentage of actual to predicted FCV | MEDIAN |
| SECONDARY | Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 24 | From baseline up to Week 24 | FAS population included all participants who were enrolled. | percentage of actual to predicted DLco | MEDIAN |
| SECONDARY | Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 52 | From baseline up to Week 52 | FAS population included all participants who were enrolled. | percentage of actual to predicted DLco | MEDIAN |
| SECONDARY | Change From Baseline in Physician's Global Assessment at Week 24 | From baseline up to Week 24 | FAS population included all participants who were enrolled. | scores on scale | MEDIAN |
| SECONDARY | Change From Baseline in Physician's Global Assessment at Week 52 | From baseline up to Week 52 | FAS population included all participants who were enrolled. | scores on scale | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 24 | Nemolizumab | -9.5 | Full Range -13 to -6 | scores on scale | |
| Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 52 | Nemolizumab | -10.0 | Full Range -14 to -7 | scores on scale | |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 | Nemolizumab | 0.000 | Full Range -0.13 to 0.38 | scores on scale | |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52 | Nemolizumab | 0.063 | Full Range -0.13 to 0.25 | scores on scale | |
| Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 24 | Nemolizumab | -1.30 | Full Range -3.5 to 5.7 | percentage of actual to predicted FCV | |
| Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 52 | Nemolizumab | -0.35 | Full Range -6.4 to 5.7 | percentage of actual to predicted FCV | |
| Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 24 | Nemolizumab | 0.55 | Full Range -4.5 to 8.8 | percentage of actual to predicted DLco | |
| Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 52 | Nemolizumab | -3 | Full Range -6.6 to 4.4 | percentage of actual to predicted DLco | |
| Change From Baseline in Physician's Global Assessment at Week 24 | Nemolizumab | -3.30 | Full Range -5.4 to -0.9 | scores on scale | |
| Change From Baseline in Physician's Global Assessment at Week 52 | Nemolizumab | -3.10 | Full Range -6.5 to -0.6 | scores on scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nemolizumab | 6 | |
| Overall Study | COMPLETED | Nemolizumab | 6 | |
| Overall Study | NOT COMPLETED | Nemolizumab | 0 |
Source ClinicalTrials.gov
Adverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Nemolizumab | 3 | 6 | |
| other | Adenoviral conjunctivitis | Infections and infestations | Nemolizumab | 1 | 6 | |
| other | Gastroenteritis | Infections and infestations | Nemolizumab | 1 | 6 | |
| other | Paronychia | Infections and infestations | Nemolizumab | 1 | 6 | |
| other | Tinea pedis | Infections and infestations | Nemolizumab | 1 | 6 | |
| other | Oral herpes | Infections and infestations | Nemolizumab | 1 | 6 | |
| other | COVID-19 | Infections and infestations | Nemolizumab | 1 | 6 | |
| other | Animal bite | Injury, poisoning and procedural complications | Nemolizumab | 1 | 6 | |
| other | Ligament sprain | Injury, poisoning and procedural complications | Nemolizumab | 1 | 6 | |
| other | Vaccination complication | Injury, poisoning and procedural complications | Nemolizumab | 1 | 6 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nemolizumab | 0 | 6 |
| Total, other adverse events | Nemolizumab | 6 | 6 |
| Total, serious adverse events | Nemolizumab | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05214794
GET https://conductscience.org/api/trials/v1/NCT05214794/registered