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DISC-0974 在骨髓纤维化和贫血参与者中的研究

2026年9月14日 更新者：Disc Medicine, Inc

一项评估 DISC-0974 在骨髓纤维化和贫血参与者中的安全性、耐受性、药代动力学和药效学的 1b/2a 期开放标签研究

这项 1b/2a 期开放标签研究将评估 DISC-0974 的安全性、耐受性、药代动力学和药效学，并将对骨髓纤维化和贫血受试者的贫血反应的影响进行分类。

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

150

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 澳大利亚
      • Nedlands、澳大利亚、6009
      • Saint Albans、澳大利亚、3021
        • 招聘中
        • Western Health
        • 接触：
        • 接触：
        • 首席研究员：
          • William Renwick, MBBS
      • Sydney、澳大利亚、2010
      • West Perth、澳大利亚、6005
        • 招聘中
        • Perth Blood Institute
        • 接触：
        • 首席研究员：
          • Ross Baker, MBBS, BMedSc, FRACP, FACP
  • 美国
    • Arizona
      • Gilbert、Arizona、美国、85234
    • California
      • Duarte、California、美国、91010
        • 招聘中
        • City of Hope - Duarte
        • 接触：
        • 接触：
        • 首席研究员：
          • Idoroenyi Amanam, MD
      • Irvine、California、美国、92618
        • 招聘中
        • City of Hope - Lennar
        • 首席研究员：
          • Idoroenyi Amanam, MD
        • 接触：
        • 接触：
      • Los Angeles、California、美国、90095
      • San Francisco、California、美国、94143
        • 招聘中
        • University of California, San Francisco
        • 首席研究员：
          • Jerry Lee, MD, MS
        • 接触：
        • 接触：
    • Colorado
      • Aurora、Colorado、美国、80045
        • 招聘中
        • University of Colorado Anschutz Medical Campus
        • 接触：
        • 首席研究员：
          • Brandon McMahon, MD
    • Florida
      • Jacksonville、Florida、美国、32224
        • 招聘中
        • Mayo Clinic Jacksonville
        • 首席研究员：
          • James Foran, MD
        • 接触：
      • Miami、Florida、美国、33136
      • Tampa、Florida、美国、33612
        • 招聘中
        • Moffitt Cancer Center
        • 首席研究员：
          • Andrew Kuykendall, MD
        • 接触：
    • Georgia
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • 招聘中
        • University of Michigan
        • 接触：
        • 首席研究员：
          • Moshe Talpaz, MD
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • 招聘中
        • Mayo Clinic Rochester
        • 首席研究员：
          • Naseema Gangat, MBBS
        • 接触：
    • Missouri
      • St Louis、Missouri、美国、63110
        • 招聘中
        • Washington University St.Louis
        • 接触：
        • 首席研究员：
          • Amy Zhou, MD
    • New Jersey
      • East Brunswick、New Jersey、美国、08816
    • New York
      • New York、New York、美国、10029
        • 招聘中
        • Icahn School of Medicine at Mount Sinai
        • 首席研究员：
          • John Mascarenhas, MD
        • 接触：
        • 接触：
      • New York、New York、美国、10021
        • 招聘中
        • Memorial Sloan Kettering Cancer Center
        • 首席研究员：
          • Prioty Islam, MD, MSc
        • 接触：
        • 接触：
      • New York、New York、美国、10467
    • North Carolina
      • Winston-Salem、North Carolina、美国、27157
        • 招聘中
        • Atrium Health Wake Forest Baptist
        • 接触：
        • 首席研究员：
          • Anne Wofford, MD
    • Ohio
      • Canton、Ohio、美国、44718
        • 终止
        • Gabrail Cancer Center Research
      • Cleveland、Ohio、美国、44195
        • 招聘中
        • Cleveland Clinic
        • 首席研究员：
          • Aaron Gerds, MD
        • 接触：
        • 接触：
      • Columbus、Ohio、美国、43201
        • 招聘中
        • The Ohio State University
        • 首席研究员：
          • Shivani Handa, MD
        • 接触：
        • 接触：
      • Maumee、Ohio、美国、43537
        • 招聘中
        • Taylor Cancer Research Center
        • 首席研究员：
          • John Nemunaitis, MD
        • 接触：
        • 接触：
    • Oregon
      • Portland、Oregon、美国、97239
        • 招聘中
        • Oregon Health and Science University
        • 接触：
        • 首席研究员：
          • Ronan Swords, MD, PhD
    • Pennsylvania
      • Gettysburg、Pennsylvania、美国、17325
        • 撤销
        • Sargon Research - Pennsylvania Cancer Specialists and Research Center
      • Philadelphia、Pennsylvania、美国、19104
    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • MD Anderson
        • 首席研究员：
          • Prithviraj Bose, MD
        • 接触：
    • Washington
      • Seattle、Washington、美国、98109
        • 招聘中
        • University of Washington
        • 首席研究员：
          • Anna Halpern, MD
        • 接触：
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • 招聘中
        • Medical College of Wisconsin
        • 首席研究员：
          • Laura Michaelis, MD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  1. 签署知情同意书 (ICF) 时年满 18 岁。
  2. 对于 1b 期：动态国际预后评分系统 (DIPSS) 评分为 3 至 4（中等 2 风险）或 ≥ 5（高风险）原发性 MF、PV 后 MF 和/或 ET 后 MF，如在根据世界卫生组织 (WHO) 2016 年标准的最新本地骨髓活检报告。
  3. 在筛选以下治疗之前至少 28 天清除：雄激素、促红细胞生成素、克拉屈滨、免疫调节剂（来那度胺、沙利度胺）、干扰素 α-2a 或任何其他 MF 导向疗法。 如果在筛选前 ≥ 28 天稳定或减少剂量并且在筛选前的 28 天内接受相当于 ≤ 10 mg 泼尼松的等效剂量，则允许全身性皮质类固醇用于非血液病症。
  4. 贫血：对于第 1b 期：筛选前 84 天的≥ 3 次评估中血红蛋白 (Hgb) < 10 g/dL，无红细胞输注，或 Hgb < 10 g/dL 且定期接受红细胞输注但不符合 TD 参与者的标准为 TD 队列定义。 这些参与者的基线 Hgb 值是筛选前 84 天内的最低 Hgb 水平，或 RBC 输血依赖性，定义为筛选前 84 天内 RBC 输注频率≥ 6 个单位浓缩 RBC (PRBC)。 在 84 天期间内不得有任何连续 42 天未输注红细胞，最后一次输血必须在筛选前 28 天内。 对于 2a 期：RBC 输血依赖，定义为在筛选前的 84 天内 RBC 输血频率≥ 6 个单位 PRBC。 在 84 天期间内不得有任何连续 42 天未输注红细胞，最后一次输血必须在筛选前 28 天内。
  5. 稳定剂量的 JAK 抑制剂和/或羟基脲，或者，如果采取任何其他 MF 治疗，在筛选前稳定至少 4 个月。
  6. 东部肿瘤合作组 (ECOG) 表现得分 ≤ 2。
  7. 预计在筛选后 8 个月内输注造血干细胞移植。
  8. MRI 显示的肝铁浓度 < 7 mg/g 干重。
  9. 筛选时血清铁蛋白≥ 30 μg/L。
  10. 血小板计数 ≥ 25,000/μL 且 < 1,000,000/μL；中性粒细胞 ≥ 1,000/μL；筛选时总白细胞 (WBC) 计数 < 50,000/μL。
  11. 估计肾小球滤过率 (eGFR) ≥ 30 mL/min/1.73m2 通过慢性肾脏病流行病学协作 (CKD-EPI) 公式。
  12. 筛选时天冬氨酸转氨酶 (AST) 和丙氨酸转氨酶 (ALT) < 3.0 x 正常值上限 (ULN)。
  13. 筛选时直接胆红素 < 2x ULN。 如果这些可以被研究者归因于无效的红细胞生成，则更高的水平是可以接受的。

排除标准：

病史：

  1. 遗传性血色素沉着症
  2. 与贫血相关的血红蛋白病或内在红细胞缺陷
  3. 脾切除术
  4. 造血干细胞移植
  5. 当前因缺铁、维生素 B12 或叶酸缺乏、感染或出血导致的贫血
  6. 主动免疫介导的溶血性贫血
  7. 在筛选前的 6 个月内，关键区域或器官出现与手术无关的症状性出血和/或导致 Hgb 降低≥ 2 g/dL 或导致输注 ≥ 2 单位红细胞的出血
  8. 筛选前 8 周内进行过大手术或之前的任何手术未完全恢复

  9. 除原发性 MF、ET 后或 PV 后 MF 外，过去 3 年内的恶性肿瘤。 允许以下历史或并发条件：

    1. 基底细胞癌或鳞状细胞癌
    2. 子宫颈或乳房原位癌
    3. 前列腺癌的组织学发现（使用肿瘤、淋巴结、转移 [TNM] 临床分期系统的 T1a 或 T1b）
  10. 筛选前 6 个月内中风、深静脉血栓形成或肺或动脉栓塞
  11. 已知对任何研究药物赋形剂有过敏反应，或对任何食物或药物有过敏反应
  12. 抗药抗体形成史
  13. 心脏病控制不佳（纽约心脏协会分类 3 或 4）和/或已知左心室射血分数 < 35%
  14. 具有可检测病毒载量的活动性乙型或丙型肝炎病毒或人类免疫缺陷病毒 (HIV)

  15. 不受控制的真菌、细菌或病毒感染（与感染相关的持续体征/症状，尽管进行了适当的治疗但仍无改善）

    治疗史：

  16. 在研究期间同时或计划使用莫美洛替尼进行治疗
  17. 筛选前 3 个月的铁螯合疗法

  18. 筛选前 8 周内抗凝治疗方案发生变化

    实验室排除：

  19. 外周血成髓细胞≥ 10% 筛选前的最近评估中的 WBC 差异
  20. 阳性直接抗球蛋白试验结合反应性红细胞洗脱液筛选

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：阶段 1b：剂量递增
在研究的 1b 期（剂量递增）部分，DISC-0974 将每 4 周皮下注射一次。
药品：DISC-0974
DISC-0974 是皮下给药的。
实验性的：第二阶段：扩张
在该研究的第 2 期（扩展）部分，DISC-0974 将每 4 周皮下注射一次。
药品：DISC-0974
DISC-0974 是皮下给药的。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Safety and Tolerability of DISC-0974 (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
Assessed by treatment-emergent adverse events
From Day 1 to the end of treatment on Day 169
Safety and Tolerability of DISC-0974 (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
Assessed by vital signs through blood pressure (mmHg), heart rate (bpm), respiration rate (breaths/min), and temperature (°C)
From Day 1 to the end of treatment on Day 169
Safety and Tolerability of DISC-0974 (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
Assessed by physical examinations
From Day 1 to the end of treatment on Day 169
Safety and Tolerability of DISC-0974 (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
Assessed by electrocardiogram (ECG) parameters: heart rate, PR interval, QRS duration, QRS axis, QT interval, and QTcF interval)
From Day 1 to the end of treatment on Day 169
Safety and Tolerability of DISC-0974 assessed through blood testing (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
The blood testing will include a hematology panel, blood chemistry panel, serology/virology panel, biomarker assessments, PK assessments, and Anti-Drug Antibodies
From Day 1 to the end of treatment on Day 169
Safety and Tolerability of DISC-0974 assessed through urine testing (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
The urine testing will include a urinalysis
From Day 1 to the end of treatment on Day 169
Transfusion-dependent (TD) high cohort: transfusion independence (Phase 2 only)
大体时间：From Day 1 to the end of treatment on Day 169
Defined as the absence of packed red blood cell (PRBC) transfusions over any rolling 12-week interval during the treatment period with a minimum hemoglobin (Hgb) of 7 g/dL. Participants meeting this criterion will be considered to have a major response to treatment.
From Day 1 to the end of treatment on Day 169
TD low cohort: transfusion independence (Phase 2 only)
大体时间：From Day 1 to the end of treatment on Day 169
Defined as the absence of PRBC transfusions over any rolling 16-week interval during the treatment period with a minimum Hgb of 7 g/dL. Participants meeting this criterion will be considered to have a major response to treatment.
From Day 1 to the end of treatment on Day 169
Non-transfusion-dependent (nTD) cohort: anemia response (Phase 2 only)
大体时间：From Day 1 to the end of treatment on Day 169
Defined as the composite of the absence of transfusions over any rolling 12-week period and a concomitant mean Hgb increase of ≥1.5 g/dL over baseline. Participants meeting this criterion will be considered to have a major response to treatment.
From Day 1 to the end of treatment on Day 169

次要结果测量

结果测量
措施说明
大体时间
Anemia response defined per IWG-MRT 2006 criteria (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
Response in nTD participants is defined as ≥2.0 g/dL increase from baseline in Hgb levels. Response in TD participants requires absence of PRBC transfusions during any rolling 12-week period during the treatment period, capped by an Hgb level of ≥8.5 g/dL.
From Day 1 to the end of treatment on Day 169
TD high and TD low participants will be evaluated for absence of PRBC transfusions for any rolling 12-week interval during the treatment period (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
TD high participants will be evaluated for absence of PRBC transfusions with minimum Hgb of 7 g/dL during any rolling 12-week interval during the treatment period (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
TD low participants will be evaluated for absence of PRBC transfusions with minimum Hgb of 7 g/dL during any rolling 16-week interval during the treatment period (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
nTD participants will be evaluated for ≥1.5 g/dL increase from baseline Hgb levels during the treatment period (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
nTD participants will be evaluated for the composite of the absence of transfusions over any rolling 12-week period and a concomitant mean Hgb increase of ≥1.5 g/dL over baseline (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Incidence of TEAEs following repeated DISC-0974 SC doses in participants with myelodysplastic syndrome (MDS) or MDS/myeloproliferative neoplasm (MPN) without excess blasts (collectively referred to as MDS) and anemia (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
Proportion of participants with treatment-emergent adverse events
From Day 1 to the end of treatment on Day 169
Incidence of clinically abnormal vital signs following repeated DISC-0974 SC doses in participants with myelodysplastic syndrome (MDS) or MDS/myeloproliferative neoplasm (MPN) without excess blasts and anemia (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Incidence of clinically abnormal physical exam following repeated DISC-0974 SC doses in participants with myelodysplastic syndrome (MDS) or MDS/myeloproliferative neoplasm (MPN) without excess blasts and anemia (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Incidence of clinically abnormal electrocardiograms (ECGs) following repeated DISC-0974 SC doses in participants with myelodysplastic syndrome (MDS) or MDS/myeloproliferative neoplasm (MPN) without excess blasts and anemia (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Incidence of abnormal laboratory test results following repeated DISC-0974 SC doses in participants with myelodysplastic syndrome (MDS) or MDS/myeloproliferative neoplasm (MPN) without excess blasts and anemia (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Pharmacokinetic data of DISC-0974 following repeated SC doses in participants with myelodysplastic syndrome (MDS) or MDS/myeloproliferative neoplasm (MPN) without excess blasts and anemia (Phase 1b only)
大体时间：From Day 1 to the end of treatment on Day 169
Pharmacokinetic parameters include DISC-0974 pre-dose concentrations at different visits
From Day 1 to the end of treatment on Day 169
Proportion of participants achieving a mean Hgb increase ≥1 g/dL or ≥2 g/dL from baseline over any rolling 12-week period in absence of PRBC transfusions in each cohort (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
Participants who are nTD and achieve a mean Hgb increase ≥1 g/dL from baseline over any rolling 12-week period in the absence of transfusion will be considered to have a minor response to treatment.
From Day 1 to the end of treatment on Day 169
PD markers of mechanism engagement, including exploratory cohorts assessed through serum iron levels (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
PD markers of mechanism engagement, including exploratory cohorts assessed through TSAT levels (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
PD markers of mechanism engagement, including exploratory cohorts assessed through Ferritin levels (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
PD markers of mechanism engagement, including exploratory cohorts assessed through Transferrin levels (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
PD markers of mechanism engagement, including exploratory cohorts assessed through Serum-hepcidin-25 levels (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Hematologic Parameters assessed through Reticulocyte count (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Hematologic Parameters assessed through Hemoglobin levels (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Hematologic Parameters assessed through Reticulocyte Hemoglobin (CHr) (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Hematologic Parameters assessed through Red Blood Cell Count (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Rate of RBC transfusions per participant month during the treatment period for each cohort (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
The number of units of RBC transfusions per participant month during the treatment period for each cohort (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Transfusion-dependent cohorts will be evaluated for proportion of participants who reduce their transfusion requirement by ≥50%, as compared to baseline, over any rolling 12-week period during treatment. (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
Participants who are TD and achieve a reduction in transfusion requirement ≥50% as compared to baseline over any rolling 12-week period during treatment will be considered to have a minor response to treatment.
From Day 1 to the end of treatment on Day 169
nTD participants will be evaluated for longest duration of mean Hgb increase of ≥1.5 g/dL from baseline during the treatment period (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Mean change in Hgb over 12-week treatment periods will be evaluated for all cohorts (nTD, TD low, and TD high) (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Maximum duration of RBC-transfusion-independent response for TD participants (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Proportion of participants that require dose escalation in each cohort (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Proportion of participants that improve Functional Assessment of Cancer Therapy-Anemia (FACT-An) subscale by at least 3 points in each cohort during the treatment period (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Mean hemoglobin increase of ≥1.5 g/dL over any rolling 12-week interval and an increase in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue of 3 points by the end of study (EOS) for nTD participants (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
TD high cohort will be evaluated for absence of packed red blood cell (PRBC) transfusions a terminal 12-week interval during the treatment period with a minimum hemoglobin (Hgb) of 7 g/dL (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
TD low cohort: will be evaluated for the absence of PRBC transfusions a terminal 16-week interval during the treatment period with a minimum Hgb of 7 g/dL (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
From Day 1 to the end of treatment on Day 169
Non-transfusion-dependent (nTD) cohort will be evaluated for anemia response (Phase 1b and 2)
大体时间：From Day 1 to the end of treatment on Day 169
Defined as the composite of the absence of transfusions over any rolling 12-week period and a concomitant mean Hgb increase of ≥1.5 g/dL over baseline
From Day 1 to the end of treatment on Day 169
Safety and Tolerability of DISC-0974 (Phase 2 only)
大体时间：From Day 1 to the end of treatment on Day 169
Assessed by treatment-emergent adverse events
From Day 1 to the end of treatment on Day 169
Safety and Tolerability of DISC-0974 (Phase 2 only)
大体时间：From Day 1 to the end of treatment on Day 169
Assessed by vital signs through blood pressure (mmHg), heart rate (bpm), respiration rate (breaths/min), and temperature (°C)
From Day 1 to the end of treatment on Day 169
Safety and Tolerability of DISC-0974 (Phase 2 only)
大体时间：From Day 1 to the end of treatment on Day 169
Assessed by physical examinations
From Day 1 to the end of treatment on Day 169
Safety and Tolerability of DISC-0974 (Phase 2 only)
大体时间：From Day 1 to the end of treatment on Day 169
Assessed by electrocardiogram (ECG) parameters: heart rate, PR interval, QRS duration, QRS axis, QT interval, and QTcF interval)
From Day 1 to the end of treatment on Day 169
Safety and Tolerability of DISC-0974 assessed through blood testing (Phase 2 only)
大体时间：From Day 1 to the end of treatment on Day 169
The blood testing will include a hematology panel, blood chemistry panel, serology/virology panel, biomarker assessments, PK assessments, and Anti-Drug Antibodies
From Day 1 to the end of treatment on Day 169
Safety and Tolerability of DISC-0974 assessed through urine testing (Phase 2 only)
大体时间：From Day 1 to the end of treatment on Day 169
The urine testing will include a urinalysis
From Day 1 to the end of treatment on Day 169
Safety and tolerability of DISC-0974 following repeated SC doses in participants with MF receiving concomitant momelotinib or pacritinib therapy (Phase 2 only)
大体时间：From Day 1 to the end of treatment on Day 169
Assessed by treatment-emergent adverse events
From Day 1 to the end of treatment on Day 169
Safety and tolerability of DISC-0974 following repeated SC doses in participants with MF receiving concomitant momelotinib or pacritinib therapy (Phase 2 only)
大体时间：From Day 1 to the end of treatment on Day 169
Assessed by vital signs through blood pressure (mmHg), heart rate (bpm), respiration rate (breaths/min), and temperature (°C)
From Day 1 to the end of treatment on Day 169
Safety and tolerability of DISC-0974 following repeated SC doses in participants with MF receiving concomitant momelotinib or pacritinib therapy (Phase 2 only)
大体时间：From Day 1 to the end of treatment on Day 169
Assessed by physical examinations
From Day 1 to the end of treatment on Day 169
Safety and tolerability of DISC-0974 following repeated SC doses in participants with MF receiving concomitant momelotinib or pacritinib therapy (Phase 2 only)
大体时间：From Day 1 to the end of treatment on Day 169
Assessed by electrocardiogram (ECG) parameters: heart rate, PR interval, QRS duration, QRS axis, QT interval, and QTcF interval)
From Day 1 to the end of treatment on Day 169
Safety and tolerability of DISC-0974 following repeated SC doses in participants with MF receiving concomitant momelotinib or pacritinib therapy assessed through blood testing (Phase 2 only)
大体时间：From Day 1 to the end of treatment on Day 169
The blood testing will include a hematology panel, blood chemistry panel, serology/virology panel, biomarker assessments, PK assessments, and Anti-Drug Antibodies
From Day 1 to the end of treatment on Day 169
Safety and tolerability of DISC-0974 following repeated SC doses in participants with MF receiving concomitant momelotinib or pacritinib therapy assessed through urine testing (Phase 2 only)
大体时间：From Day 1 to the end of treatment on Day 169
The urine testing will include a urinalysis
From Day 1 to the end of treatment on Day 169

其他结果措施

结果测量
措施说明
大体时间
Cmax (Phase 1b, 2, and Exploratory Cohorts)
大体时间：From Day 1 to the end of treatment on Day 169
Maximum drug concentration (observed). Will be determined from blood PK sampling if appropriate data are available
From Day 1 to the end of treatment on Day 169
Tmax (Phase 1b, 2, and Exploratory Cohorts)
大体时间：From Day 1 to the end of treatment on Day 169
Observed time of the maximum drug concentration. Will be determined from blood PK sampling if appropriate data are available
From Day 1 to the end of treatment on Day 169
AUC (Phase 1b, 2, and Exploratory Cohorts)
大体时间：From Day 0 to 29 days after the first dose
Area under the drug concentration-time curve calculated using linear trapezoidal summation from time zero to 29 days following the first dose. Will be determined from blood PK sampling if appropriate data are available.
From Day 0 to 29 days after the first dose

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Disc Medicine, Inc

调查人员

  • 研究主任：Will Savage, MD PhD、Disc Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年6月6日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2022年3月15日

首先提交符合 QC 标准的

2022年4月1日

首次发布 (实际的)

2022年4月11日

研究记录更新

最后更新发布 (实际的)

2026年9月15日

上次提交的符合 QC 标准的更新

2026年9月14日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • DISC-0974-102

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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