OpSCF 对中度至重度特应性皮炎的疗效和安全性的 2a 期研究
2026年8月17日 更新者：Insmed Incorporated
一项随机、双盲、安慰剂对照 2a 期研究，旨在评估 OpSCF 治疗中度至重度特应性皮炎成人受试者的疗效和安全性
本研究的目的是确定单克隆抗体 OpSCF 治疗成人中度至重度特应性皮炎（湿疹）的有效性和安全性。 OpSCF 将与安慰剂进行比较。
OpSCF 或安慰剂将每 2 周施用一次，持续 14 周，两周后评估疗效。 此后，受试者可以选择进入开放标签扩展阶段，其中所有受试者将每 4 周接受一次 OpSCF，持续 40 周。
研究概览
研究类型
介入性
注册 (实际的)
50
阶段
- 阶段2
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。
学习地点
-
-
Ontario
-
Oshawa、Ontario、加拿大、L1H 1B9
- Oshawa Clinic Dermatology Trials
-
Toronto、Ontario、加拿大、M4W 2N2
- Research Toronto
-
-
Quebec
-
Montreal、Quebec、加拿大、H2X 2V1
- Innovaderm Research Inc
-
Québec、Quebec、加拿大、G1W 4R4
- Centre de Recherche Saint-Louis
-
-
-
-
Alabama
-
Birmingham、Alabama、美国、33607
- Cahaba Dermatology & Skin Health Center
-
-
California
-
Fountain Valley、California、美国、92708
- First OC Dermatology Research
-
Inglewood、California、美国、90301
- Axon Clinical Research
-
San Diego、California、美国、92123
- University Clinical Trials
-
Sherman Oaks、California、美国、91403
- Unison Clinical Trials
-
-
Florida
-
Boca Raton、Florida、美国、33456
- Skin Care Research
-
Miami、Florida、美国、33173
- Skin Research of South Florida
-
Miami Lakes、Florida、美国、33014
- RM Medical Research
-
Tampa、Florida、美国、33607
- Advanced Clinical Research Institute
-
-
Illinois
-
Rolling Meadows、Illinois、美国、60008
- Arlington Dermatology
-
-
Indiana
-
West Lafayette、Indiana、美国、47906
- Options Research Group
-
-
Kentucky
-
Louisville、Kentucky、美国、40241
- DS Research of Kentucky
-
-
Michigan
-
Auburn Hills、Michigan、美国、48326
- Oakland Hills Dermatology P.C
-
Bay City、Michigan、美国、48706
- Saginaw Bay Dermatology
-
-
Nevada
-
Reno、Nevada、美国、89509
- Skin Cancer and Dermatology Institute
-
-
New York
-
Kew Gardens、New York、美国、11415
- Forest Hills Dermatology Group
-
-
Texas
-
Frisco、Texas、美国、75034
- Rodgers Dermatology
-
-
Washington
-
Bellevue、Washington、美国、98004
- Dermatology Of Seattle
-
-
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
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 受试者已临床确诊为活动性 AD
- 受试者有至少 6 个月的 AD 病史
- 受试者愿意使用有效的节育措施
排除标准：
- 受试者是在研究期间母乳喂养、怀孕或计划怀孕的女性。
- 受试者患有任何临床上显着的医疗状况，该状况会使受试者面临过度风险或干扰研究结果的解释。
- 受试者在第 1 天之前的 26 周内使用过 dupilumab
- 受试者在第 1 天之前的 12 周内使用过 tralokinumab
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：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：OpSCF 600 mg
Participants received OpSCF 600 milligrams (mg), once every 2 weeks (Q2W), subcutaneously (SC), up to 14 weeks in the placebo-controlled period.
|
Administered SC.
其他名称：
|
|
安慰剂比较：OpSCF Matching-Placebo
Participants received OpSCF matching-placebo, Q2W, SC, up to 14 weeks in the placebo-controlled period.
|
Administered SC.
|
|
实验性的：OpSCF 600 mg/OpSCF 600mg
Participants who received OpSCF 600 mg and completed placebo-controlled treatment received OpSCF 600mg, once every 4 weeks (Q4W), SC, up to 36 weeks in the open-label extension (OLE) period.
|
Administered SC.
其他名称：
Administered SC.
|
|
安慰剂比较：OpSCF Matching-Placebo/OpSCF 600 mg
Participants who received OpSCF matching-placebo and completed placebo-controlled treatment received OpSCF 600mg, Q4W, SC, up to 36 weeks in the OLE period.
|
Administered SC.
其他名称：
Administered SC.
|
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 |
|---|---|---|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 16
大体时间：Baseline, Week 16
|
The EASI quantifies the severity of a participant's AD based on both lesion severity and the % of body surface area (BSA) affected.
Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe.
EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) and 6(90 to 100%).
The EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al.
Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD.
Here, a negative change from baseline indicates less severity in AD.
|
Baseline, Week 16
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Who Experienced At-Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Events (SAEs)
大体时间：From first dose of study drug up to end of follow-up (up to Week 67)
|
An adverse event (AE) was any untoward medical occurrence in participant administered a pharmaceutical product & that does not necessarily have a causal relationship with this treatment.
It can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study product, whether or not considered related to the study product.
An SAE was any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization resulted in persistent or significant disability/incapacity & was a congenital anomaly/birth defect.
Any AE starting on or after the first dose date will be considered TEAE.
|
From first dose of study drug up to end of follow-up (up to Week 67)
|
|
Percent Change From Baseline in EASI at Weeks 2, 4, 6, 8, 10, 12, and 14
大体时间：Baseline, Weeks 2, 4, 6, 8, 10, 12 and 14
|
The EASI quantifies the severity of a participant's AD based on both lesion severity and the % of body surface area (BSA) affected.
Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe.
EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) and 6(90 to 100%).
The EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al.
Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD.
Here, a negative change from baseline indicates less severity in AD.
|
Baseline, Weeks 2, 4, 6, 8, 10, 12 and 14
|
|
Change From Baseline in EASI at Weeks 2, 4, 6, 8, 10, 12, 14, and 16
大体时间：Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
The EASI quantifies the severity of a participant's AD based on both lesion severity and the % of body surface area (BSA) affected.
Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe.
EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) and 6(90 to 100%).
The EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al.
Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD.
Here, a negative change from baseline indicates less severity in AD.
|
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
|
Percentage of Participants Achieving At-Least 50% Improvement From Baseline in EASI (EASI50)
大体时间：At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
The EASI quantifies severity of a participant's AD based on both lesion severity & % of body surface area (BSA) affected.
Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0=absent; 1=mild; 2=moderate; 3=severe.
EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) & 6(90 to 100%).
EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al.
Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD.
Here, a negative change from baseline indicates less severity in AD.
EASI 50 response was defined as at least a 50% improvement in EASI relative to Baseline.
90% CI was based on exact Clopper-Pearson method.
|
At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
|
Percentage of Participants Achieving At-Least 75% Improvement From Baseline in EASI (EASI75)
大体时间：At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
The EASI quantifies severity of a participant's AD based on both lesion severity & % of body surface area (BSA) affected.
Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0=absent; 1=mild; 2=moderate; 3=severe.
EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) & 6(90 to 100%).
EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al.
Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD.
Here, a negative change from baseline indicates less severity in AD.
EASI 75 response was defined as at least a 75% improvement in EASI relative to Baseline.
90% CI was based on exact Clopper-Pearson method.
|
At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
|
Percentage of Participants Achieving At-Least 90% Improvement From Baseline in EASI (EASI90)
大体时间：At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
The EASI quantifies severity of a participant's AD based on both lesion severity & % of body surface area (BSA) affected.
Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0=absent; 1=mild; 2=moderate; 3=severe.
EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) & 6(90 to 100%).
EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al.
Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD.
Here, a negative change from baseline indicates less severity in AD.
EASI 90 response was defined as at least a 90% improvement in EASI relative to Baseline.
90% CI was based on exact Clopper-Pearson method.
|
At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
|
Percentage of Participants Achieving At-Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)
大体时间：At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
The vIGA-AD was assessed by the principal investigator or sub-investigator using the descriptors that best described the overall appearance of the lesions.
It is a 5-point morphological assessment of overall disease severity that ranges from 0 to 4, where 0 = Clear; No inflammatory signs of atopic dermatitis 1 = Almost clear; Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification 2 = Mild; Slight but definite erythema (pink), slight but definite induration/papulation, and/ or slight but definite lichenification 3 = Moderate; Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification 4 = Severe; Marked erythema (deep or bright red), marked induration/ papulation, and/or marked lichenification.
Percentage of participants who achieved at least a 2-grade reduction from baseline to clear (0) or Almost Clear (1) in vIGA-AD are reported here.
|
At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
|
Percentage of Participants Achieving At-Least a 2-grade Reduction From Baseline in vIGA-AD
大体时间：At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
The vIGA-AD was assessed by the principal investigator or sub-investigator using the descriptors that best described the overall appearance of the lesions.
It is a 5-point morphological assessment of overall disease severity that ranges from 0 to 4, where 0 = Clear; No inflammatory signs of atopic dermatitis 1 = Almost clear; Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification 2 = Mild; Slight but definite erythema (pink), slight but definite induration/papulation, and/ or slight but definite lichenification 3 = Moderate; Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification 4 = Severe; Marked erythema (deep or bright red), marked induration/ papulation, and/or marked lichenification.
The percentage of participants with reduction from baseline of ≥2 grade in vIGA-AD score has been reported.
|
At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
|
Change From Baseline in Weekly Average of the Daily Peak Pruritus Numeric Rating Scale (PP-NRS)
大体时间：Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
PP-NRS is based on the Numeric Rating Scale which was used to assess the level of itch the participant was experiencing.
The following question was asked to participants: "On a scale of 0 to 10, with 0 = "no itch" and 10 = "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?"
Based on the score provided by participant, the PP-NRS score was assigned.
Higher score indicates more severity.
A negative change from baseline indicates improvement.
|
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
|
Percent Change From Baseline in Weekly Average of the Daily PP-NRS
大体时间：Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
PP-NRS is based on the Numeric Rating Scale which was used to assess the level of itch the participant was experiencing.
The following question was asked to participants: "On a scale of 0 to 10, with 0 = "no itch" and 10 = "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?"
Based on the score provided by participant, the PP-NRS score was assigned.
Higher score indicates more severity.
A negative change from baseline indicates improvement.
|
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
|
Percentage of Participants Achieving At-Least a 4-point Reduction From Baseline in Weekly Average of the Daily PP-NRS
大体时间：Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
PP-NRS is based on the Numeric Rating Scale which was used to assess the level of itch the participant was experiencing.
The following question was be asked to participants: "On a scale of 0 to 10, with 0 = "no itch" and 10 = "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?"
Based on the score provided by participant, the PP-NRS score was assigned.
Higher score indicates more severity.
A negative change from Baseline indicates improvement.
The percentage of participants who had at least a 4-point reduction in the NRS score at post-baseline visits has been reported.
|
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
|
Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD)
大体时间：Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
The overall BSA affected by AD was evaluated (from 0% to 100%).
It was calculated using the palm surface area method.
This method states that palmar surface of 1 hand (using the participant's hand and including the fingers) represents 1% of his or her total BSA.
|
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
|
Percent Change From Baseline in BSA Involved With AD
大体时间：Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
The overall BSA affected by AD was evaluated (from 0% to 100%).
It was calculated using the palm surface area method.
This method states that palmar surface of 1 hand (using the participant's hand and including the fingers) represents 1% of his or her total BSA.
|
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
|
Change From Baseline in Atopic Dermatitis Control Tool (ADCT) at Weeks 2, 4, 8, 12, and 16
大体时间：Baseline, Weeks 2, 4, 8,12 and 16
|
ADCT questionnaire is a self-assessment comprised of 6 concise questions to evaluate participant's perceptions of AD symptoms and impacts on their life and function over the last week.
Each question carries equal weight and is scored from 0 to 4, for a total score ranging between 0 and 24.
Higher score indicates higher severity.
A negative change from baseline indicates improvement.
|
Baseline, Weeks 2, 4, 8,12 and 16
|
|
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Weeks 2, 4, 8, 12, and 16
大体时间：Baseline, Weeks 2, 4, 8,12 and 16
|
POEM is a self-assessment of disease severity using 7 questions asked to participant.
A maximum value of 28 can be assigned based on the participant's response to 7 questions scored from 0 to 4, where 0 = No days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days and 4 = Every day.
Higher score indicates high severity.
A negative change from baseline indicates improvement.
|
Baseline, Weeks 2, 4, 8,12 and 16
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12, and 16
大体时间：Baseline, Weeks 2, 4, 8,12 and 16
|
DLQI is a 10 questions questionnaire to measure how much skin problems have affected a participant's life over the last week.
Each question is scored from 0 to 3 (0 = Not at all, 1 = A little, 2 = A lot and 3 = Very much).
The DLQI is calculated by summing the score of each question, giving a total score ranging from 0 (not at all) to 30 (very much).
The higher the score the more quality of life is impaired.
A negative change from baseline indicates improvement in QoL.
|
Baseline, Weeks 2, 4, 8,12 and 16
|
|
Placebo-controlled Period: Serum Concentrations of OpSCF Over Time
大体时间：Days 15, 29, 43, 57, 85, 99, 102, 106 and 113
|
Days 15, 29, 43, 57, 85, 99, 102, 106 and 113
|
|
|
OLE Period: Serum Concentrations of OpSCF Over Time
大体时间：Days 141, 169, 197, 225, 253, 281, 309 and 337
|
Days 141, 169, 197, 225, 253, 281, 309 and 337
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
第 4、8、12 和 16 周时血液生物标志物和 IgE 相对于基线的变化
大体时间：16周
|
血液检查
|
16周
|
|
第 4 周和第 16 周时使用皮肤活检收集的皮肤生物标志物相对于基线的变化（对于同意的受试者可选）
大体时间：16周
|
组织病理学检查
|
16周
|
|
第 4 周和第 16 周使用胶带收集的皮肤生物标志物相对于基线的变化（对于同意的受试者可选）
大体时间：16周
|
蛋白质组学和 mRNA 水平分析
|
16周
|
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。
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)
2023年11月21日
初级完成 (实际的)
2024年9月3日
研究完成 (实际的)
2025年8月18日
研究注册日期
首次提交
2023年10月19日
首先提交符合 QC 标准的
2023年10月25日
首次发布 (实际的)
2023年10月26日
研究记录更新
最后更新发布 (实际的)
2026年9月11日
上次提交的符合 QC 标准的更新
2026年8月17日
最后验证
2026年8月1日
更多信息
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.