Systemic SclerosisPhase 2NCT07047690
A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
A Phase 2 study testing Nemolizumab in people with Systemic Sclerosis, run by Galderma R&D at 3 sites in 2 countries.
Trial summary
The main purpose of the study is to investigate the efficacy on cutaneous thickness and the safety of Nemolizumab in adult patients with systemic sclerosis after a 52-week treatment period and to select the optimal dose for this target population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Nemolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 20 Feb 2026to 23 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be 18 years of age or older, at the time of signing the Informed Consent Form.
- Classification of systemic sclerosis (SSc) as defined by the 2013 American College of Rheumatology [ACR]/European League Against Rheumatism [EULAR] criteria.
- Modified Rodnan Skin Score.
- Diffuse cutaneous systemic sclerosis (DcSSc) participants and modified Rodnan Skin Score (mRSS) of greater than equal to (>=)12 and less than (<)30 at both screening and baseline
- Limited cutaneous systemic sclerosis (LcSSc) participants with mRSS >=8 at both screening and baseline. LcSSc participants with positive anti-centromere at screening are excluded.
- Disease duration in DcSSc participants <= 5 years from screening and LcSSc participants <=2 years from screening is defined as the time from the first non-Raynaud's phenomenon manifestation of SSc.
Show all 15Show fewer
- Participants are permitted to receive the following background therapies stable for at least 3 months prior to baseline, including any combination of the following:
- Nintedanib (<150mg twice daily) and/or
- One of the following:
- Methotrexate (MTX) (<25mg weekly) or
- Mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or mycophenolic acid (MPA) (<3000mg daily MMF, <2160mg daily for MPS or MPA) NOTE: MTX should not be used in combination with MMF/MPS/MPA
- Participants with evidence for active or progressive disease.
- Men (whose female partner can become pregnant) and women of childbearing potential will be required to use effective means of contraception or commit to true abstinence, when this is in line with preferred and usual lifestyle of the participant, during the study and for at least 12 weeks after receiving the last study treatment.
- Female participants of non-childbearing potential
- Signed informed consent
Who cannot join
- Anti-centromere antibody positive at screening for participants with LcSSc.
- Anti-RNA polymerase 3 antibody positive for participants with a disease duration >18months.
- Creatinine clearance <30 milli liter per minute [ml/min] (calculated by Cockcroft-Gault formula).
- Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HbcAb], hepatitis C [HCV] antibody with positive confirmatory test for hepatitis C virus [HCV] antibody with positive HCV RNA, or human immunodeficiency virus [HIV] antibody).
- FVC <50% of predicted normal value, and DLCO <40% of predicted normal value (corrected for Hb) at screening and baseline.
- Known diagnosis of clinically significant respiratory disorders other than ILD, including severe chronic obstructive pulmonary disease, severe asthma, recent (within 3 months) severe respiratory infections or history of recurrent respiratory infections, smoking, and any other respiratory condition that, in the opinion of the investigator, could interfere with the study or pose a risk to the participant.
Show all 26Show fewer
- Currently listed and/or anticipated to be listed for lung transplantation within the next 12 months.
- Cardiovascular disease with clinically significant arrhythmia requiring therapy, congestive heart failure (New York Heart Association Class III-IV functional capacity), unstable angina, uncontrolled hypertension, Cor pulmonale, or symptomatic pericardial effusion.
- History of myocardial infarction in the last 6 months prior to screening.
- Pulmonary hypertension WHO Functional Class III or higher (as defined by WHO 2009) requiring treatment.
- Clinical signs of severe malabsorption in the opinion of the investigator or needing parenteral nutrition.
- History of scleroderma renal crisis (SRC) 6 months prior to screening.
- Participants with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment).
- Body weight of <30.0 kilogram (Kg) at screening or BL
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed, or unwilling to use appropriate contraception measures during the study period
- Previous treatment with nemolizumab
- Participants with the primary diagnosis of a rheumatic autoimmune disease other than SSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, systemic vasculitis, Sjogren's syndrome, anti-synthetase syndrome, or mixed CTD, as determined by the investigator with consultation of the medical monitors
- Systemic sclerosis-like illness including but not limited to localized scleroderma (morphea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro mucinous conditions (scleredema, scleromyxedema), scleroderma-like conditions that are associated with environmental chemical and drug exposure (e.g., toxic rapeseed oil, vinyl chloride, bleomycin, gadolinium-based contrast agents [nephrogenic systemic fibrosis], or due to metabolic disease)
- History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, e.g., monoclonal antibody) or to any of the study treatment excipient
- Known active bacterial, viral, fungal, or any major episode of infection requiring hospitalization or treatment with IV antibiotics or antivirals within 4 weeks prior to screening, or oral antibiotics within 2 weeks prior to screening. Participants may be rescreened once the infection has resolved.
- History of a primary immunodeficiency
- History of Bone Morrow Transplantation. Chimeric Antigen Receptor (CAR)-T Cell Therapy or any other genetically engineering cells
- History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for (1) basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the BL visit, or (2) actinic keratoses that have been treated
- History of alcohol or substance abuse dependence or any condition that, in the investigator's opinion makes the participant unreliable to following instructions and complete the study
- In the opinion of the investigator, the participant has any medical condition, including clinically significant pulmonary abnormalities, or psychological condition,or clinically significant laboratory abnormalities that could pose undue risk to the participant, prevent study completion or adversely affect the validity or interpretability of the study measurements or interfere with the study assessments, or impede the participant's ability to complete the study.
- Participant has not adhered to the restrictions in select treatments prior to screening or is not expected to be compliant with restrictions during the study
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Galderma Investigational Site # 8743
Ann Arbor, Michigan, 48109-5000
Galderma Project Manager
- Recruiting
Galderma Investigational Site#7096
Arlington, Texas, 76012
Galderma Project Manager
Switzerland1 site, 1 recruiting
- Recruiting
Galderma Investigational Site # 6213
Sankt Gallen, 9007
Galderma Project Manager
About this study
Official title: A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of Nemolizumab in Adult Patients With Systemic Sclerosis
The main purpose of the study is to investigate the efficacy on cutaneous thickness and the safety of Nemolizumab in adult patients with systemic sclerosis after a 52-week treatment period and to select the optimal dose for this target population.
- Conditions
- Systemic Sclerosis
- Being tested
- Nemolizumab, Placebo
- Keywords
- Limited Cutaneous Systemic Sclerosis, Diffuse Cutaneous Systemic Sclerosis, Interstitial Lung Disease
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Limited, Scleroderma, Diffuse, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NemolizumabDrug
Also called CD14152
Subcutaneous Injection
PlaceboDrug
Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Nemolizumab Dose 1 | Experimental | Not described Receives: Drug: Nemolizumab |
| Nemolizumab Dose 2 | Experimental | Not described Receives: Drug: Nemolizumab |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (BL) in Modified Rodnan Skin Score (mRSS) 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.
Measured: Baseline, at Week 52
Secondary outcomes (13)
Change From Baseline in Forced Vital Capacity (FVC) at Week 52
FVC will be assessed with the Flow screen spirometer.
Measured: Baseline, at Week 52
Proportion of Responders to the Treatment Based on the Revised Composite Response Index in Systemic Sclerosis (rCRISS) 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.
Measured: At Week 52
Change From Baseline in mRSS at Weeks 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.
Measured: Baseline, at Week 8, 12, 24, 28, 36, 44, 52
Percent change from Baseline in mRSS 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.
Measured: Baseline, at Week 52
Change from Baseline in Percent Predicted FVC (ppFVC) at Week 52
FVC will be assessed with the Flow screen spirometer.
Measured: Baseline, at Week 52
Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) 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.
Measured: Baseline, at Week 52
Percent Change From Baseline in Patient's Global Assessment (PGA) Score 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.
Measured: Baseline, at Week 52
Percent Change From Baseline in Clinician's Global Assessment (CGA) Score 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.
Measured: Baseline, at Week 52
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.
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).
Measured: From baseline of study intervention to 12 weeks after last dose (52 weeks)
Incidence of Abnormal Vital Signs
Change from BL in pulse rate, blood pressure, respiration rate, and body temperature will be assessed by visit and treatment group including participants with treatment emergent changes.
Measured: From baseline of study intervention to 12 weeks after last dose (52 weeks)
Incidence of Abnormal Laboratory Parameters
Change from BL in hematology, clinical chemistry, and lipid variables will be assessed by visit and treatment group including participants with treatment-emergent changes.
Measured: From baseline of study intervention to 12 weeks after last dose (52 weeks)
Incidence of Abnormal Electrocardiogram (ECG) Findings
Observed values of heart rate, QRS duration, PR interval, RR interval and QT interval will be summarized by visit and treatment group including participants with clinically significant abnormal results.
Measured: From baseline of study intervention to 12 weeks after last dose (52 weeks)
Incidence of Abnormal Weight Change
Change from BL in weight (kilograms) will be assessed by visit and treatment and medically significant changes will be recorded as adverse events.
Measured: From baseline of study intervention to 12 weeks after last dose (52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start20 Feb 2026
- Primary completion28 May 2028 (estimated)
- Study completion23 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047690
- Sponsor's protocol ID
- SPR207796
- Status last verified
- Nov 2025
- First submitted
- 24 Jun 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of Nemolizumab in Adult Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT07047690
- Acronym / sponsor ID
- SPR207796
- Conditions
- Systemic Sclerosis
- Keywords
- Limited Cutaneous Systemic Sclerosis, Diffuse Cutaneous Systemic Sclerosis, Interstitial Lung Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 28 May 2028 (estimated)
- Study completion
- 23 Jul 2028 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study is to investigate the efficacy on cutaneous thickness and the safety of Nemolizumab in adult patients with systemic sclerosis after a 52-week treatment period and to select the optimal dose for this target population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nemolizumab Dose 1 | Experimental | Drug: Nemolizumab |
| Nemolizumab Dose 2 | Experimental | Drug: Nemolizumab |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Participant must be 18 years of age or older, at the time of signing the Informed Consent Form.
- Classification of systemic sclerosis (SSc) as defined by the 2013 American College of Rheumatology [ACR]/European League Against Rheumatism [EULAR] criteria.
- Modified Rodnan Skin Score.
- Disease duration in DcSSc participants <= 5 years from screening and LcSSc participants <=2 years from screening is defined as the time from the first non-Raynaud's phenomenon manifestation of SSc.
- Participants are permitted to receive the following background therapies stable for at least 3 months prior to baseline, including any combination of the following:
Key exclusion criteria (26 listed)
- Anti-centromere antibody positive at screening for participants with LcSSc.
- Anti-RNA polymerase 3 antibody positive for participants with a disease duration >18months.
- Creatinine clearance <30 milli liter per minute [ml/min] (calculated by Cockcroft-Gault formula).
- Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HbcAb], hepatitis C [HCV] antibody with positive confirmatory test for hepatitis C virus [HCV] antibody with positive HCV RNA, or human immunodeficiency virus [HIV] antibody).
- FVC <50% of predicted normal value, and DLCO <40% of predicted normal value (corrected for Hb) at screening and baseline.
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 |
|---|---|---|
| NemolizumabAlso: CD14152Subcutaneous Injection | Drug | Nemolizumab Dose 1, Nemolizumab Dose 2 |
| PlaceboSubcutaneous Injection | Drug | Placebo |
Primary outcome
Change From Baseline (BL) in Modified Rodnan Skin Score (mRSS) at Week 52
Time frame: 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.
13 secondary outcomes
Change From Baseline in Forced Vital Capacity (FVC) at Week 52
Time frame: Baseline, at Week 52
Proportion of Responders to the Treatment Based on the Revised Composite Response Index in Systemic Sclerosis (rCRISS) at Week 52
Time frame: At Week 52
Change From Baseline in mRSS at Weeks 8, 12, 24, 28, 36, 44, 52
Time frame: Baseline, at Week 8, 12, 24, 28, 36, 44, 52
Percent change from Baseline in mRSS at Week 52
Time frame: Baseline, at Week 52
Change from Baseline in Percent Predicted FVC (ppFVC) at Week 52
Time frame: Baseline, at Week 52
Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52
Time frame: Baseline, at Week 52
Percent Change From Baseline in Patient's Global Assessment (PGA) Score at Week 52
Time frame: Baseline, at Week 52
Percent Change From Baseline in Clinician's Global Assessment (CGA) Score at Week 52
Time frame: Baseline, at Week 52
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.
Time frame: From baseline of study intervention to 12 weeks after last dose (52 weeks)
Incidence of Abnormal Vital Signs
Time frame: From baseline of study intervention to 12 weeks after last dose (52 weeks)
Incidence of Abnormal Laboratory Parameters
Time frame: From baseline of study intervention to 12 weeks after last dose (52 weeks)
Incidence of Abnormal Electrocardiogram (ECG) Findings
Time frame: From baseline of study intervention to 12 weeks after last dose (52 weeks)
Incidence of Abnormal Weight Change
Time frame: From baseline of study intervention to 12 weeks after last dose (52 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Systemic Sclerosis
Not yet recruitingPhase 2
Hyaluronidase Injections for Sclerodactyly in Patients With Scleroderma
Scleroderma, Sclerodactyly
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
Systemic Sclerosis (SSc), Calcinosis Cutis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
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.
3 sites in 2 countries: 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 Galderma R&D at 3 sites in 2 countries.
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 15 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Switzerland. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Galderma Research and Development (817-961-5000, clinical.studies@galderma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline (BL) in Modified Rodnan Skin Score (mRSS) at Week 52 (time frame: Baseline, at Week 52). 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 31 Mar 2026.