2023-509743-27-00已完成2 期
A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 56
研究概览
简要总结
• To assess the safety and tolerability of MK-7240/PRA023 in SSc-ILD • To compare the annual rate of change from Baseline in forced vital capacity (FVC) in mL of MK-7240/PRA023 vs. placebo over 50 weeks
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（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •1.Male or female ≥ 18 years of age. 2.Subjects must meet the 2013 ACR/EULAR definition of SSc. 3.Subjects must have had SSc onset (defined by first non-Raynaud symptom) ≤ 5 years (60 months) prior to screening. 4.Subjects must have diffuse cutaneous scleroderma defined as any level of skin thickening proximal to the elbows and knees exclusive of the face and neck. Total mRSS must be 10 to 35 units, inclusive. 5.Subjects must have SSc-related ILD of fibrotic disease in lung confirmed by HRCT ≥ 10% extent of involvement, assessed by central reading. 6.FVC ≥ 45% of predicted normal. 7.Diffusing capacity of lung for carbon monoxide (DLCO) ≥ 45% of predicted normal (corrected for hemoglobin [Hgb]). 8.Meet at least one of the following criteria: a. C-reactive protein (CRP) > upper limit of normal (ULN) b. Erythrocyte sedimentation rate (ESR) > 28 mm/hr c. Positive for anti-topoisomerase (anti-Scl-70) antibody 9.Background therapy is not required, but subjects receiving background therapy must meet drug stabilization requirements, as applicable: a.Either mycophenolate mofetil (not to exceed 3 g/day) or oral or subcutaneous methotrexate (not to exceed 25 mg/week) or azathioprine (not to exceed 150 mg/day) for ≥ 4 months prior to randomization (not more than 1 therapy) and on a stable dose for 4 weeks prior to randomization b.Subjects who have been on nintedanib for ≥ 6 months (and stable dose for at least 4 weeks) prior to randomization may enter the study provided that there has not been any improvement in FVC (% and absolute) from prior to the initiation of nintedanib therapy c.A stable dose of oral corticosteroids (≤ 10 mg/day prednisone equivalent) for 2 weeks prior to randomization. Inhaled and topical corticosteroids are permitted.
- •10.A female subject is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: • Is not a woman of childbearing potential (WOCBP) OR • Is a WOCBP and: - Uses an acceptable contraceptive method, or is abstinent from penilevaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis),from at least 4 weeks prior to Day 1/Week 0, during the intervention period, and for at least 14 weeks after the last dose of study intervention. The Investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by WOCBP should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. For any background medications, the local label should be followed for contraception. - Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. - Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a WOCBP with an early undetected pregnancy 11.Able to provide written informed consent and understand and comply with the requirements of the study.
排除标准
- •1.Subjects with a history of cancer within the last 5 years (other than (other than non-melanoma skin cell cancers cured by local resection or cervical carcinoma in situ).Existing non-melanoma skin cell cancers must be removed prior to enrollment. Subjects with carcinoma in situ or localized cervical cancer, treated with definitive surgical intervention, are allowed.
- •Subject has active TB or meets TB exclusionary parameters 3.Subjects with chronic or recurrent infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis).
- •Subjects with any active infections (excluding fungal infections of nail beds) including, but not limited to, those that require IV or IM antimicrobial treatment 4 weeks or oral antimicrobial treatment 2 weeks prior to randomization. 5.Subjects known to be infected with HBV, HCV, or HIV • Participants with positive HBsAg are excluded from the study. Participants with negative HBsAg and positive HBcAb must have further testing for HBV-DNA. Participants with HBV-DNA ≥LLOQ are not eligible for the study. Participants with HBV-DNA
研究组 & 干预措施
Placebo is 0.9% normal saline. It is identical to IMP and its pharmaceutical form is solution for infusion.
Placebo
干预措施: Placebo is 0.9% normal saline. It is identical to IMP and its pharmaceutical form is solution for infusion. (Drug)
tulisokibart, tulisokibart
Test
干预措施: tulisokibart (Drug)
研究者
Sonia Villegas
Scientific
Prometheus Biosciences Inc.
研究点 (56)
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