EUCTR2018-003273-10-HU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 Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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. Able to understand and voluntarily sign the informed consent
- •2. Male or female = 18 years of age at the time of signing the informed consent
- •3. Fulfill one of the following criteria for DM:
- •a. Bohan and Peter’s criteria
- •b. ACR/EULAR criteria
- •4. Subject has active DM as determined by the investigator
- •5. Disease activity/severity fulfils one of the following three criteria:
- •i. MDGA = 3 cm (0-10 cm scale) and MMT-8 score = 142 (out of 150 total possible)
- •ii. Sum of MDGA, PtGA and EMGA VAS scores is = 10 cm (all scales individually on 0-10 cm scale)
- •iii. MDGA = 3 cm and CDASI activity score of >14
- •6. Stable doses of immunosuppressive medications for DM as defined by:
- •a. Unchanged dose of oral corticosteroids = 20 mg per day prednisone or equivalent for = 4 weeks before Visit 1
- •b. Unchanged dose of immunosuppressive medications other than oral corticosteroids for = 8 weeks before Screening
- •7. Willing to not start or stop any immunosuppressive medications for DM from Screening through end of study, unless a change is part of the protocol or considered in the subject’s best medical interest by the site investigator or another physician who has primary responsibility for treating the subject’s DM.
- •8. Willing to not use any cannabinoids, including recreational marijuana, medical marijuana and other prescription cannabinoids from Screening through end of study.
- •9. Able to adhere to the study visit schedule and other protocol requirements and follow study restrictions.
- •10. Women of childbearing potential (WOCBP) must not be pregnant or breastfeeding and must be using at least one recommended method of contraception for at least 4 weeks before Visit 1 and be willing to continue its use for at least 4 weeks after discontinuation of study product.
- •11. Male subjects must be willing to follow contraceptive requirements and should not get anyone pregnant while they are taking the study product or within 4 weeks 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 recommended method of contraception.
- •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 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Unstable DM or DM with end-stage organ involvement at Screening or Visit 1, including:
- •a. On an organ transplantation list or has received an organ transplant, except corneal transplant
- •b. Interstitial lung disease requiring constant oxygen therapy. This excludes oxygen used to aid sleep or exercise
- •c. Pulmonary hypertension requiring constant oxygen therapy. This excludes oxygen used to aid sleep or exercise
- •d. Subjects requiring supplemental tube feeding or parenteral nutrition
- •2. Certain medications at Visit 1, including:
- •a. Treatment with intravenous corticosteroids within 4 weeks before Visit 1 (Note: treatment with intra-articular corticosteroids within 4 weeks before Visit 1 is allowed)
- •b. Treatment with oral or intravenous antibiotics or antiviral treatments for new bacterial or viral infections within 4 weeks of Visit 1. This does not include prophylactic antibiotics or antiviral treatments
- •c. Any investigational agent within 30 days or 5 therapeutic half-lives of that agent whichever is longer, before Visit 1
- •3. Significant diseases or conditions other than DM that may influence response to the study product or safety, such as:
- •a. Acute or chronic hepatitis B or C infection (HBsAg or HCV RNA positivity)
- •b. Human immunodeficiency virus infection
- •c. History of active tuberculosis or positive tuberculosis test without a completed course of appropriate treatment or having already completed at least 1 month of ongoing appropriate treatment
- •d. Evidence of cancer (except for treated basal or squamous cell carcinoma of the skin or cervical carcinoma in situ) within 3 years of Visit 1
- •Note: Overlap with features of SSc, systemic lupus erythematosus, Sjogren’s syndrome, or rheumatoid arthritis is allowed if the dominant clinical disease is DM.
- •4. Any of the following values for laboratory tests at Screening:
- •a. A positive pregnancy test in women of child-bearing potential (WOCBP) - also at Visit 1
- •b. Hemoglobin < 9 g/dL in males and < 8 g/dL in females
- •c. Neutrophils < 1.0 × 10^9/L
- •d. Platelets < 75 × 10^9/L
- •e. Creatinine clearance < 50 mL/min on screening blood test, per the Modification of Diet in Renal Disease Study or in 24 hour urine creatine clearance measurement
- •5. Significant diseases or conditions other than DM or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
研究者
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