EUCTR2018-003273-10-IT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 for probable or definite DM (Bohan and Peter,1975a; Bohan and Peter 1975b)
- •b. ACR/EULAR criteria (Lundberg et al, 2017)
- •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 they or their male sexual partner must be using at least one acceptable method of contraception (see Appendix 1) 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 acceptable contraceptive requirements (see Appendix 1) 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 f emale sexual 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 19
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 or intramuscular 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 (see Section 8.2.6)
- •b. Human immunodeficiency virus infection (see Section 8.2.6)
- •c. History of active tuberculosis or positive tuberculosis test without a completed course of appropriate treatment. Having already completed at least 1 month of appropriate treatment is eligible.
- •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/1.73 m2 on screening blood
- •test, per the Modification of Diet in Renal Disease Study or in 24 hour
- •urine creatine clearance measurement
- •5. Any known hypersensitivity to lenabasum or any of its excipients.
- •6.Any medical, psychiatric or substance abuse condition, concurrent medical therapies, or abnormal laboratory values that in the opinion of the site investigator may put the subject at greater safety risk, influence response to study product, or interfere with study assessments
- •7. Subjects who have been accommodated in an institution as a result of official or judicial decision. When there is doubt as to subject eligibility, the investigator or qualified designee should discuss a subject's eligibility with the Medical Monitor.
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