Actively Recruiting
A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
Led by Galderma R&D · Updated on 2026-03-31
162
Participants Needed
3
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older at the time of signing the Informed Consent Form
- Diagnosis of systemic sclerosis as defined by the 2013 ACR/EULAR criteria
- For diffuse cutaneous systemic sclerosis (DcSSc), Modified Rodnan Skin Score (mRSS) between 12 and less than 30 at screening and baseline
- For limited cutaneous systemic sclerosis (LcSSc), mRSS of 8 or higher at screening and baseline; LcSSc participants must be negative for anti-centromere antibody
- Disease duration of 5 years or less for DcSSc and 2 years or less for LcSSc from the first non-Raynaud's symptom
- Stable use of allowed background therapies (nintedanib less than 150mg twice daily; methotrexate less than 25mg weekly; or mycophenolate mofetil/mycophenolate sodium/mycophenolic acid within specified doses) for at least 3 months prior to baseline
- Evidence of active or progressive disease
- Men with partners who can become pregnant and women of childbearing potential must agree to use effective contraception or true abstinence during the study and for 12 weeks after last treatment
- Female participants of non-childbearing potential
- Signed informed consent
You will not qualify if you...
- Positive anti-centromere antibody in LcSSc participants
- Positive anti-RNA polymerase 3 antibody for disease duration over 18 months
- Creatinine clearance less than 30 ml/min
- Positive hepatitis B surface antigen or core antibody, hepatitis C antibody with positive confirmatory HCV RNA, or HIV antibody
- Forced vital capacity (FVC) less than 50% predicted and DLCO less than 40% predicted at screening and baseline
- Significant respiratory disorders other than interstitial lung disease, including severe COPD, severe asthma, recent severe respiratory infections, smoking, or other respiratory conditions posing risk
- Listed or expected to be listed for lung transplantation within 12 months
- Clinically significant cardiovascular disease requiring therapy, recent myocardial infarction, pulmonary hypertension WHO Class III or higher
- Severe malabsorption or needing parenteral nutrition
- History of scleroderma renal crisis within 6 months
- Chronic liver disease (Child Pugh A, B, C)
- Body weight under 30 kg at screening or baseline
- Pregnant or breastfeeding women, or women planning pregnancy or unwilling to use contraception
- Previous treatment with nemolizumab
- Diagnosis of other rheumatic autoimmune diseases besides systemic sclerosis
- Systemic sclerosis-like illnesses or scleroderma-like conditions from environmental or metabolic causes
- History of hypersensitivity to immunoglobulin products or study treatment excipients
- Active infections requiring hospitalization or IV treatment within 4 weeks, or oral antibiotics within 2 weeks prior to screening
- History of primary immunodeficiency
- History of bone marrow transplantation, CAR-T cell therapy, or other genetically engineered cells
- History of lymphoproliferative disease or malignancy within 5 years except certain treated skin or cervical cancers
- History of alcohol or substance abuse or conditions impairing study compliance
- Any other medical or psychological condition that could pose risk, interfere with study assessments, or prevent completion
- Noncompliance with treatment restrictions prior to screening or expected noncompliance during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Galderma Investigational Site # 8743
Ann Arbor, Michigan, United States, 48109-5000
Actively Recruiting
2
Galderma Investigational Site#7096
Arlington, Texas, United States, 76012
Actively Recruiting
3
Galderma Investigational Site # 6213
Sankt Gallen, Switzerland, 9007
Actively Recruiting
Research Team
G
Galderma Research and Development
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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