A Phase 2 interventional study of Nemolizumab and Placebo in Systemic Sclerosis, sponsored by Galderma R&D. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Galderma R&D (part of Galderma Group AG) · Phase 2, Interventional, and Treatment
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.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 162 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Galderma R&D is the lead sponsor of 284 studies on the registry; 11 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 55 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Modified Rodnan Skin Score.
Participants are permitted to receive the following background therapies stable for at least 3 months prior to baseline, including any combination of the following:
One of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Nemolizumab
Drug: Nemolizumab
Drug: Placebo
Subcutaneous Injection
Also known as: CD14152
Subcutaneous Injection
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.
Time frame: Baseline, at Week 52
Change From Baseline in Forced Vital Capacity (FVC) at Week 52
FVC will be assessed with the Flow screen spirometer.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, at Week 52
Change from Baseline in Percent Predicted FVC (ppFVC) at Week 52
FVC will be assessed with the Flow screen spirometer.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline of study intervention to 12 weeks after last dose (52 weeks)
Plan to share: No
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Studies of the drug tested here: Nemolizumab