2025-522294-11-00招募中2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Nemolizumab in Adult Patients with Systemic Sclerosis, including a 52-Week Main Treatment Period and a 156-Week Extension Treatment Period
Galderma S.A.73 个研究点 分布在 6 个国家目标入组 56 人开始时间: 2026年6月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 73
研究概览
简要总结
- To evaluate the efficacy of nemolizumab on cutaneous thickness compared to placebo in adult patients with SSc after a 52-week treatment period and to select the optimal dose for this target population
- To evaluate the safety of nemolizumab in adult patients with SSc throughout a 156-week extension treatment period
研究设计
- 分配方式
- Na
- 主要目的
- Follow-up Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must be 18 years of age or older, or meet the legal adult age requirement in the country of enrollment (if higher than 18), at the time of signing the informed consent.
- •Classification of SSc as defined by the 2013 American College of Rheumatology [ACR]/European League Against Rheumatism [EULAR] criteria
- •Participants with modified Rodnan Skin Score: a. DcSSc participants and modified Rodnan Skin Score (mRSS) of ≥12 and <30 at both screening and baseline b. LcSSc participants with mRSS ≥8 at both screening and baseline. LcSSc participants with positive anti-centromere at screening are excluded.
- •Participants are included in the study if the disease duration is: a. DcSSc participants ≤5 years from screening b. LcSSc participants ≤2 years from screening Disease duration 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: a. Nintedanib (≤150mg twice daily) and/or b. One of the following: 1) Methotrexate (MTX) (≤25mg weekly) or 2) 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 should meet: a. Early disease duration (≤18 months at screening, defined as time from the first non−Raynaud phenomenon manifestation) b. OR if disease duration is >18 months, at least two of seven the following criteria at screening (anti-RNA polymerase III antibody positive for participants with a disease duration of >18 months are excluded): 1) Two new body areas within the previous 6 months 2) Increase in mRSS of ≥ 3 units compared with the most recent assessment performed within the previous 6 months 3) Involvement of one new body area and an increase in mRSS of ≥2 units compared with the most recent assessment performed within the previous 6 months 4) Tendon friction rub documented by medical records within 3 months or presence of arthritis or tenosynovitis not explainable by other causes other than SSc 5) High sensitivity CRP (hsCRP) 6.0 mg/L (≥ 0.6 mg/dL) or ESR ≥ 28 mm/hr. 6) SSc-ILD (confirmed by HRCT central reading) or Anti-topoisomerase I autoantibodies (anti-Scl-70) positive (≥ 20 U/mL) 7) mDAI ≥2.5
- •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. Contraceptive measures such as Plan B™, sold for emergency use after unprotected sex, are not acceptable methods for routine use.
- •Female participants of non-childbearing potential must meet 1 of the following criteria: a. Absence of menstrual bleeding for 1 year prior to screening without any other medical reason. For women under 60, postmenopausal status should be confirmed. by a follicle-stimulating hormone (FSH) level ≥40 IU/L, while no FSH confirmation is needed for women over
- •b. Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before screening
- •Participants who signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. Participant who is willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including use of an electronic eCOA/ePRO type device.
排除标准
- •Laboratory Parameters
- •Anti-centromere antibody positive at screening for participants with LcSSc.
- •anti-RNA polymerase III antibody positive for participants with a disease duration >18 months
- •Creatinine clearance <30 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
- •Participants with 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.
- •Participants with the history of a primary immunodeficiency and the below history are excluded from the study. Patients with History of Bone Morrow Transplantation. Chimeric Antigen Receptor (CAR)-T Cell Therapy or any other genetically engineering cells are excluded from the study. Patients with 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 baseline visit, or (2) actinic keratoses that have been treated are excluded from the study. Patients who have had 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 are excluded.
- •In the opinion of the investigator, the participant that 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.
- •The participant that has not adhered to the restrictions in the selected treatments prior to screening or is not expected to be compliant with restrictions during the study( systemic corticosteroids,anti-malarials,ciclosporin A, tacrolimus,calcineurin inhibitors, cyclophosphamide, chloramnucil, biologics,anti CD-20 therapies,cell depleting therapies,total lymphoid radiation,thalidomide,intravenous imunoglobulin,antifibrotic agent,Soluble guanylate-cyclase modulators, JAK inhibitors,Tyrosine-kinase inhibitor, -penicillamine and investigational drug) should be excluded.
- •Participants should not abuse alcohol or other substances while they are in the study
- •Lung Diseases FVC <50% of predicted normal value (i.e., ppFVC <50%) , and DLCO <40% of predicted normal value (corrected for Hb) (i.e., ppDLCOc <40%) at screening. Participants with 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. Participants who are currently listed and/or anticipated to be listed for lung transplantation within the next 12 months.
- •Participants with 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. Participants with 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. Participants with clinical signs of severe malabsorption in the opinion of the investigator or needing parenteral nutrition. Participants with history of SRC 6 months prior to screening. Participants with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment)
- •Participants with the body weight of <30.0 kg at screening or baseline.
- •Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed, or unwilling to use appropriate contraception measures during the study period are excluded.
- •Participant who have had previous treatment with nemolizumab are excluded.
- •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 are excluded.
- •Participants with systemic sclerosis-like illness including but not limited to localized scleroderma (morphea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibromucinous 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)
- •Participants with 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
研究组 & 干预措施
Nemluvio 30 mg powder and solvent for solution for injection in pre-filled pen
Test
干预措施: Nemluvio 30 mg powder and solvent for solution for injection in pre-filled pen (Drug)
Placebo Lyophilized Powder for Solution for Injection
Placebo
干预措施: Placebo Lyophilized Powder for Solution for Injection (Drug)
研究者
Julie Zhu (Senior Medical Expert)
Scientific
Galderma S.A.
研究点 (73)
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