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New treatment option for Systemic Sclerosis
Official title A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
ClinicalTrials.gov ID: NCT07047690
What this study is testing
What is Nemolizumab?
Nemolizumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for systemic sclerosis.
Also referred to as CD14152.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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]...
- 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...
- Limited cutaneous systemic sclerosis (LcSSc) participants with mRSS \>=8 at both screening and baseline. LcSSc participants with positive...
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
Who can 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.
- 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...
- Female participants of non-childbearing potential
- Signed informed consent
What rules you out
- 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...
- 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...
- 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...
- 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...
- Systemic sclerosis-like illness including but not limited to localized scleroderma (morphea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro mucinous conditions (scleredema, scleromyxedema)...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
- Arlington, Texas, United States
- Sankt Gallen, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States; Arlington, Texas, United States; Sankt Gallen, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.