Actively Recruiting
A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of Nemolizumab in Adult Patients With Systemic Sclerosis
Led by Galderma R&D · Updated on 2026-03-31
162
Participants Needed
3
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Nemolizumab on skin thickness and safety in adults with systemic sclerosis over a 52-week treatment period. The study aims to find the best dose for this group of patients. It is a randomized, double-blind, placebo-controlled Phase 2 trial sponsored by Galderma R&D, focusing on systemic sclerosis, a condition affecting skin and internal organs. Participants will receive subcutaneous injections of either one of two doses of Nemolizumab or a placebo. The trial includes a 52-week treatment period during which patients are monitored closely for changes in skin thickness and lung function. The study also tracks safety and tolerability through various assessments throughout and up to 12 weeks after the last dose. During the study, participants will undergo regular evaluations including skin scoring with the Modified Rodnan Skin Score, lung function tests like forced vital capacity, and questionnaires assessing disability and global health. Safety monitoring includes checking for adverse events, vital signs, laboratory tests, ECGs, and weight changes. The total participation time covers the 52-week treatment and the follow-up period, allowing thorough observation of treatment effects and safety.
CONDITIONS
Brief Title
A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 years or older at the time of signing consent
- Diagnosis of systemic sclerosis according to 2013 ACR/EULAR criteria
- Modified Rodnan Skin Score (mRSS) between 12 and less than 30 for diffuse cutaneous systemic sclerosis (DcSSc) or mRSS 8 or higher for limited cutaneous systemic sclerosis (LcSSc) without positive anti-centromere antibodies
- Disease duration of 5 years or less for DcSSc and 2 years or less for LcSSc from first non-Raynaud's symptom
- Stable background therapies for at least 3 months prior to baseline, including specified doses of Nintedanib, Methotrexate, or Mycophenolate derivatives
- Evidence of active or progressive disease
- Men with partners who can become pregnant and women of childbearing potential must use effective contraception or abstain during the study and for 12 weeks after last dose
- Female participants who are not of childbearing potential
- Signed informed consent form
You will not qualify if you...
- Positive anti-centromere antibody in LcSSc participants
- Positive anti-RNA polymerase 3 antibody with disease duration over 18 months
- Creatinine clearance less than 30 ml/min
- Positive hepatitis B, hepatitis C, or HIV serology
- Forced vital capacity (FVC) less than 50% and diffusing capacity for carbon monoxide (DLCO) less than 40% at screening and baseline
- Severe respiratory disorders, recent severe infections, smoking, or other conditions affecting lungs
- Listed or anticipated for lung transplantation within 12 months
- Significant cardiovascular diseases including arrhythmia, heart failure, unstable angina, uncontrolled hypertension, or pericardial effusion
- Myocardial infarction history within 6 months prior to screening
- Pulmonary hypertension WHO Functional Class III or higher requiring treatment
- Severe malabsorption or need for parenteral nutrition
- History of scleroderma renal crisis within 6 months
- Chronic liver disease (Child Pugh A, B, or C)
- Body weight less than 30 kg
- Pregnant or breastfeeding women or unwilling to use contraception
- Previous treatment with nemolizumab
- Other rheumatic autoimmune diseases besides systemic sclerosis
- Scleroderma-like illnesses or conditions related to environmental exposures
- History of hypersensitivity to immunoglobulin products or study excipients
- Active or recent major infections requiring hospitalization or treatment
- History of primary immunodeficiency
- History of bone marrow transplantation, CAR-T therapy, or genetic cell engineering
- History of lymphoproliferative disease or malignancy within 5 years except certain skin or cervical conditions
- History of substance abuse or conditions impacting study compliance
- Medical or psychological conditions that pose risk or interfere with study assessments
- Non-compliance with treatment restrictions prior to screening or expected during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 52 weeks
Participants receive subcutaneous injections of Nemolizumab or placebo to treat systemic sclerosis.
Multiple visits across 52 weeks
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
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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