Trial · NCT07047690
A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
NCT07047690, Phase 2, Recruiting, Galderma R&D
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis. Trials, record NCT07047690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07047690
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
- NCT number
- NCT07047690
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 162 participants, estimated
- Lead sponsor
- Galderma R&D
- Conditions
- Systemic Sclerosis
- Interventions
- Nemolizumab, Placebo
- First posted
- 2025-07-02
- Last updated
- 2026-03-31
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (BL) in Modified Rodnan Skin Score (mRSS) at Week 52 | Baseline, at Week 52 | mRSS is the assessment of skin involvement includes semiquantitative estimation of skin thickness, pliability (hardness), and fixation to underlying structures (tethering).Cutaneous thickness is assessed in 17 body surface areas using a 0-3 scale, where mRSS of score 0="normal" with fine wrinkles but no skin thickness; score 1="mild" skin thickness; score 2= "moderate" skin thickness with difficulty in making skin folds and no wrinkles; and score 3="severe" skin thickness with inability to make skin folds between 2 examining fingers. Where higher score indicating more severe disease. |
| Secondary | Change From Baseline in Forced Vital Capacity (FVC) at Week 52 | Baseline, at Week 52 | FVC will be assessed with the Flow screen spirometer. |
| Secondary | Proportion of Responders to the Treatment Based on the Revised Composite Response Index in Systemic Sclerosis (rCRISS) at Week 52 | At Week 52 | Responders are defined as participants who meet all the following criteria: Improvement in 2 out of the 5 rCRISS components \>=5% absolute increase from BL in ppFVC (percent predicted forced vital capacity), \>=25% relative decrease from BL in mRSS, Health Assessment Questionnaire Disability Index (HAQ-DI), PGA (Patient's Global Assessment), CGA(Clinician/Physician's Global Assessment) score. Worsening in no more than 1 rCRISS component \>=5% absolute decrease from BL in ppFVC, \>=25% relative increase from BL in mRSS, HAQ-DI, PGA, CGA score. No significant SSc-related event. |
| Secondary | Change From Baseline in mRSS at Weeks 8, 12, 24, 28, 36, 44, 52 | Baseline, at Week 8, 12, 24, 28, 36, 44, 52 | mRSS is the assessment of skin involvement includes semiquantitative estimation of skin thickness, pliability (hardness), and fixation to underlying structures (tethering).Cutaneous thickness is assessed in 17 body surface areas using a 0-3 scale, where mRSS of score 0="normal" with fine wrinkles but no skin thickness; score 1="mild" skin thickness; score 2= "moderate" skin thickness with difficulty in making skin folds and no wrinkles; and score 3="severe" skin thickness with inability to make skin folds between 2 examining fingers. Where higher score indicating more severe disease. |
| Secondary | Percent change from Baseline in mRSS at Week 52 | Baseline, at Week 52 | mRSS is the assessment of skin involvement includes semiquantitative estimation of skin thickness, pliability (hardness), and fixation to underlying structures (tethering).Cutaneous thickness is assessed in 17 body surface areas using a 0-3 scale, where mRSS of score 0="normal" with fine wrinkles but no skin thickness; score 1="mild" skin thickness; score 2= "moderate" skin thickness with difficulty in making skin folds and no wrinkles; and score 3="severe" skin thickness with inability to make skin folds between 2 examining fingers. Where higher score indicating more severe disease. |
| Secondary | Change from Baseline in Percent Predicted FVC (ppFVC) at Week 52 | Baseline, at Week 52 | FVC will be assessed with the Flow screen spirometer. |
| Secondary | Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52 | Baseline, at Week 52 | HAQ-DI is a participant-reported questionnaire and sensitive to change in disease activity (cutaneous and visceral involvement and with changes in physiological parameters over time).Each question is rated on a 0 to 3 scale (0 = without difficulty; 3 = unable to do), and additional points can be added if aids or devices (i.e., cane, walker) are needed for specific activities. An increased score indicated worse functionality. |
| Secondary | Percent Change From Baseline in Patient's Global Assessment (PGA) Score at Week 52 | Baseline, at Week 52 | The participant's global impression of health Numeric Rating Scale 0-10 (NRS) will be self-administered by the participant. 0 represents excellent and 10 represents extremely poor. |
| Secondary | Percent Change From Baseline in Clinician's Global Assessment (CGA) Score at Week 52 | Baseline, at Week 52 | The clinician global impression of health Numeric Rating Scale 0-10 (NRS) will be filled out by the participant's clinician after all other study procedures have been completed. 0 represents excellent and 10 represents extremely poor. |
| Secondary | Incidence and Severity of TEAEs, Treatment-Emergent SAEs, Treatment-Emergent AEs of Special Interest (AESIs), Significant SSc-Related TEAEs, TEAEs Leading to Investigational Product Discontinuation and Study Discontinuation. | From baseline of study intervention to 12 weeks after last dose (52 weeks) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A Serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: Results in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, Other serious (important medical events). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT07047690
GET https://conductscience.org/api/trials/v1/NCT07047690/registered