A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2a/b Study Assessing the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
研究概览
详细说明
This study is a Phase 2a/b, randomized, double-blind, placebo-controlled, multi-center trial involving participants with SjD. The study consists of three parts (Part A, Part B, and Part C).
The study includes a screening period of up to 8 weeks to assess eligibility, a 52-week treatment period, and a 4-week safety follow-up period after the last dose of study treatment.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Novartis Pharmaceuticals
- 电话号码：1-888-669-6682
- 邮箱：novartis.email@novartis.com
研究联系人备份
- 姓名：Novartis Pharmaceuticals
- 电话号码：+41613241111
学习地点
-
-
-
Kfar Saba、以色列、4428164
- 招聘中
- Novartis Investigative Site
-
Petah Tikva、以色列、4941492
- 招聘中
- Novartis Investigative Site
-
Ramat Gan、以色列、5265601
- 招聘中
- Novartis Investigative Site
-
Ẕerifin、以色列、7030000
- 招聘中
- Novartis Investigative Site
-
-
-
-
Quebec
-
Sherbrooke、Quebec、加拿大、J1G 2E8
- 招聘中
- Novartis Investigative Site
-
-
-
-
Queensland
-
Southport、Queensland、澳大利亚、4222
- 招聘中
- Novartis Investigative Site
-
-
-
-
Florida
-
Tampa、Florida、美国、33603
- 招聘中
- Clinical Research of West Florida Inc
-
首席研究员：
- John Carter
-
接触：
- Sydney K Mullen
- 电话号码：+1 813 870 1292
- 邮箱：smullen@crwf.com
-
-
Oklahoma
-
Oklahoma City、Oklahoma、美国、73116
- 招聘中
- RAO Research LLC
-
首席研究员：
- Latisha Heinlen
-
接触：
- Erica Beer
- 电话号码：+1 405 608 8060
- 邮箱：ebeer@raoklahoma.com
-
-
Texas
-
Bellaire、Texas、美国、77401
- 招聘中
- Novel Research LLC
-
首席研究员：
- Wajeeha Yousaf
-
接触：
- Hassan Khan
- 电话号码：+1 281 944 3610
- 邮箱：khan@novelresearch.net
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Key Inclusion Criteria:
• Participants must have a diagnosis of SjD according to the ACR/EULAR 2016 classification criteria at screening:
- Positive anti-Ro (SSA) antibodies at screening. Participants negative for anti-Ro/SSA antibodies are eligible if they have documented previous biopsy showing evidence of salivary gland inflammation consistent with SjD.
Key Exclusion Criteria:
- Presence of another autoimmune rheumatic disease that is active at screening and constitutes the principal illness.
Exclusion based on medications being used for SjD:
- Participants taking > 400 mg/day hydroxychloroquine are excluded. Participants taking ≤400 mg/day hydroxychloroquine should be on a stable dose for at least 4 weeks prior to randomization.
- Participants taking > 400 mg/day hydroxychloroquine are excluded. Participants on ≤ 400 mg/day of hydroxychloroquine should be on a stable dose for at least 4 weeks prior to randomization.
- Prior treatment with any of the following within 3 months prior to randomization: belimumab, abatacept, anti-tumor necrosis factor alpha biologic agents, immunoglobulins, plasmapheresis, intravenous (i.v.) or oral cyclophosphamide, mycophenolate mofetil, i.v. or oral cyclosporine A, or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors, IL-2, anti-IL-6, anti-IL-17).
- Previous treatment with any cell-depleting therapies, including but not limited to anti-CD20, unless ≥ 12 months prior to screening.
- Any viral, bacterial or other infections at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infection.
- History of malignancy of any organ system (other than localized non melanoma carcinoma of the skin or in situ cervical cancer) within the last five years of randomization or any malignancy not in remission.
Other protocol-defined inclusion/exclusion criteria may apply.
学习计划
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Part A- DDY391 dose level 1
DDY391 dose level 1
|
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
|
实验性的：Part A-Placebo
Matching placebo.
At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.
|
匹配安慰剂
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
|
实验性的：Part B- DDY391 dose level 1
DDY391 dose level 1
|
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
|
实验性的：Part B- DDY391 dose level 2
DDY391 dose level 2
|
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
|
实验性的：Part B- DDY391 dose level 3
DDY391 dose level 3
|
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
|
实验性的：Part B- Placebo
Matching placebo.
At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.
|
匹配安慰剂
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
|
实验性的：Part C- DDY391 dose level 1
DDY391 dose level 1
|
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
|
实验性的：Part C- Placebo
Matching placebo.
At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.
|
匹配安慰剂
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
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 |
|---|---|---|
|
Part A and B: Change from baseline in ESSDAI score
大体时间：Baseline, Week 24
|
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a validated tool for assessing disease activity in SjD.
Score range is 0-123.
Higher scores on the ESSDAI scale are associated with poorer health states.
A negative change from baseline indicates improvement in disease status.
|
Baseline, Week 24
|
|
Part C: Change from baseline in ESSPRI
大体时间：Baseline, Week 24
|
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a validated disease outcome measure for SjD.
It consists of three domains of dryness, pain, and fatigue.
The participant will assess severity of symptoms they experienced over the last 14 days on a single 0-10 numerical rating scale for each of the three domains.
The ESSPRI score is defined as the mean of scores from the three scales: (dryness + pain + fatigue) /3.
The total ESSPRI score ranges from 0 (no symptoms) to 10 (maximal symptom severity).
|
Baseline, Week 24
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Part A and B: Change from baseline in ESSPRI
大体时间：Baseline, Week 24
|
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a validated disease outcome measure for SjD.
It consists of three domains of dryness, pain, and fatigue.
The participant will assess severity of symptoms they experienced over the last 14 days on a single 0-10 numerical rating scale for each of the three domains.
The ESSPRI score is defined as the mean of scores from the three scales: (dryness + pain + fatigue) /3.
The total ESSPRI score ranges from 0 (no symptoms) to 10 (maximal symptom severity).
|
Baseline, Week 24
|
|
Part A, B and C: Change from baseline in SSSD
大体时间：Baseline, Week 24
|
Sjögren's Syndrome Symptom Diary (SSSD) includes six items specific to SjD (eye dryness, mouth dryness skin dryness, tiredness, muscle and/or joint pain, and genital dryness).
The total score ranges from 0 (no symptoms) to 10 (maximal symptom severity).
|
Baseline, Week 24
|
|
Part A, B and C: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Baseline up to Week 52
|
To evaluate the safety and tolerability of multiple doses of DDY391.
|
Baseline up to Week 52
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CDDY391B12201
- 2025 (美国 NIH 拨款/合同：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-524513-92-00 (其他标识符：EU CTIS)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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.