EUCTR2017-000372-29-NL进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 354
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Fulfills the 2013 American College of Rheumatology criteria for systemic sclerosis (van den Hoogen et al, 2013).
- •2. Diffuse cutaneous SSc (skin thickening on upper arms proximal to the elbows, upper legs proximal to the knees, or trunk).
- •3. = 18 years of age at the time Informed Consent is signed.
- •4. Written informed consent from the subject.
- •5. Disease duration = 6 years from the first non-Raynaud’s symptom. If disease duration is > 3 years and = 6 years, then mRSS = 15. Subjects with disease duration > 3 years and = 6 years and mRSS = 15 will be limited to no more than 1/3rd of the subjects.
- •6. Patient Global Assessment = 3 or MDGA = 3.
- •7. Stable treatment for SSc = 28 days before Visit 1.
- •8. Willing to not start or stop any immunosuppressive medications for SSc from Visit 1 through Visit 11, unless a change is considered in the subject’s best medical interest by the site investigator or another physician who has primary responsibility for treating the subject’s
- •9. Willing not to use any cannabinoids including recreational marijuana, medical marijuana and other prescription cannabinoids from Screening through Visit 11.
- •10. Women of childbearing potential must not be pregnant or breastfeeding at Screening or Visit 1 and must be using at least one highly effective method of contraception (failure rate < 1% per year) for
- •at least 28 days before Visit 1 and be willing to continue to use at least one highly effective method of contraception throughout the study and for at least 28 days after discontinuation of study product.
- •11. Male participants must be willing to follow contraceptive requirements and should not get anyone pregnant while they are taking the study product or within 28 days after taking the last dose of the study product, during which time period they or their partner must be willing to use at least one highly effective method of contraception.
- •12. Able to adhere to the study visit schedule and other protocol requirements.
- •13. Complete dosing in Part A without permanent discontinuation of
- •study product for safety or tolerability reasons or voluntary withdrawal
- •from the study.
- •14. Complete Visit 11 of Part A.
- •15. Understand and voluntarily sign the informed consent.
- •16. Able to adhere to the study visit schedule and other protocol
- •requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 329
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1, such as:
- •a. On an organ transplantation list or has received an organ transplant (previous autologous bone marrow/stem cell transplantation is permitted, but such cases should be discussed individually with the medical monitor).
- •b. Renal crisis within 1 year
- •c. Interstitial lung disease requiring constant oxygen treatment. This excludes oxygen used to aid sleep or exercise.
- •d. Pulmonary hypertension requiring constant oxygen treatment. This excludes oxygen used to aid sleep or exercise.
- •e. Gastrointestinal dysmotility requiring total parenteral nutrition or hospitalization within 6 months before Visit 1.
- •2. Certain medications at Screening or Visit 1, including:
- •a. Treatment with any oral prednisone > 10 mg per day or equivalent within 28 days before Visit 1. Treatment with intravenous corticosteroids within 28 days before Visit 1 is not allowed, and treatment with intra-articular corticosteroids within 28 days before Visit 1 is allowed (topical corticosteroids are allowed).
- •b. New or increase in doses of any non-corticosteroid immunosuppressive medication within 8 weeks before Screening.
- •c. Treatment with cyclophosphamide within 3 months before Visit 1.
- •3. Concomitant inflammatory myositis, rheumatoid arthritis, or systemic lupus erythematosus when definite classification criteria for those diseases are met (Bohan and Peter criteria for polymyositis and dermatomyositis [Bohan and Peter, 1975a; Bhan and Peter, 1975b]; 2010 rheumatoid arthritis classification criteria of American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) [Aletaha, 2010]; ACR revised criteria for the classification of systemic lupus erythematosus [Hochberg, 1997]).
- •4. SSc-like illnesses related to exposures or ingestions.
- •5. A positive test for anti-centromere antibody at Screening. If the subject is anti-centromere antibody positive and clearly has diffuse cutaneous SSc, then the subject may be eligible and the investigator must discuss this situation with the Medical Monitor to determine eligibility.
- •6. Significant diseases or conditions other than SSc that may influence response to the study product or safety, such as:
- •a. A new bacterial or viral infection that was treated with oral or intravenous antibiotics or anti-viral treatments within 28 days before Visit 1. This does not include prophylactic antibiotic or anti-viral treatments or treatment for gastrointestinal bacterial overgrowth.
- •b. Acute or chronic hepatitis B or C infection.
- •c. Human immunodeficiency virus (HIV) infection.
- •d. History of active tuberculosis or positive tuberculosis test without a completed course of appropriate treatment or already completed at least 1 month of ongoing appropriate treatment.
- •e. Evidence of required treatment for cancer (except for treated, localized basal or squamous cell carcinoma of the skin or cervical carcinoma in situ) within 3 years of Visit 1.
- •7. Any of the following values for laboratory tests at Screening:
- •a. A positive pregnancy test in WOCBP (also at Visit 1).
- •b. Hemoglobin < 9 g/dL in males and < 8 g/dL in females
- •c. Neutrophils < 1.0 × 1000,000,000/L
- •d. Platelets < 75 × 1000,000,000/L
- •e. Creatinine clearance in blood < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation. Creatinine clearance may be assessed in a 24-hour urine collection to confirm eligibility (creatinine
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