중등도에서 중증 아토피성 피부염에 대한 OpSCF의 효능 및 안전성에 대한 제2a상 연구
2026년 8월 17일 업데이트: Insmed Incorporated
중등도에서 중증 아토피성 피부염이 있는 성인 피험자의 치료에 있어 OpSCF의 효능과 안전성을 평가하기 위한 무작위, 이중 맹검, 위약 대조, 2a상 연구
이 연구의 목적은 중등도에서 중증의 아토피성 피부염(습진)이 있는 성인의 치료에서 단일클론 항체인 OpSCF의 효능과 안전성을 확인하는 것입니다. OpSCF는 위약과 비교됩니다.
OpSCF 또는 위약을 2주 간격으로 14주 동안 투여하고 2주 후에 유효성을 평가할 예정이다. 그 후, 피험자는 추가 40주 동안 모든 피험자가 4주마다 OpSCF를 받는 오픈 라벨 확장 단계에 들어가기로 선택할 수 있습니다.
연구 개요
연구 유형
중재적
등록 (실제)
50
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 33607
- Cahaba Dermatology & Skin Health Center
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California
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Fountain Valley, California, 미국, 92708
- First OC Dermatology Research
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Inglewood, California, 미국, 90301
- Axon Clinical Research
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San Diego, California, 미국, 92123
- University Clinical Trials
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Sherman Oaks, California, 미국, 91403
- Unison Clinical Trials
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Florida
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Boca Raton, Florida, 미국, 33456
- Skin Care Research
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Miami, Florida, 미국, 33173
- Skin Research of South Florida
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Miami Lakes, Florida, 미국, 33014
- RM Medical Research
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Tampa, Florida, 미국, 33607
- Advanced Clinical Research Institute
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Illinois
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Rolling Meadows, Illinois, 미국, 60008
- Arlington Dermatology
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Indiana
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West Lafayette, Indiana, 미국, 47906
- Options Research Group
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Kentucky
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Louisville, Kentucky, 미국, 40241
- DS Research of Kentucky
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Michigan
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Auburn Hills, Michigan, 미국, 48326
- Oakland Hills Dermatology P.C
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Bay City, Michigan, 미국, 48706
- Saginaw Bay Dermatology
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Nevada
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Reno, Nevada, 미국, 89509
- Skin Cancer and Dermatology Institute
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New York
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Kew Gardens, New York, 미국, 11415
- Forest Hills Dermatology Group
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Texas
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Frisco, Texas, 미국, 75034
- Rodgers Dermatology
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Washington
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Bellevue, Washington, 미국, 98004
- Dermatology Of Seattle
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Ontario
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Oshawa, Ontario, 캐나다, L1H 1B9
- Oshawa Clinic Dermatology Trials
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Toronto, Ontario, 캐나다, M4W 2N2
- Research Toronto
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Quebec
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Montreal, Quebec, 캐나다, H2X 2V1
- Innovaderm Research Inc
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Québec, Quebec, 캐나다, G1W 4R4
- Centre de Recherche Saint-Louis
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 피험자는 활성 AD 진단을 임상적으로 확인했습니다.
- 피험자는 최소 6개월 간의 AD 병력을 가지고 있습니다.
- 피험자는 효과적인 피임법을 사용할 의향이 있습니다.
제외 기준:
- 피험자는 모유 수유 중이거나 임신 중이거나 연구 기간 동안 임신할 계획이 있는 여성입니다.
- 피험자는 피험자를 과도한 위험에 빠뜨리거나 연구 결과의 해석을 방해할 수 있는 임상적으로 중요한 의학적 상태를 가지고 있습니다.
- 대상자는 1일 전 26주 이내에 두필루맙을 사용했습니다.
- 피험자는 1일 전 12주 이내에 트랄로키누맙을 사용했습니다.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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Administered SC.
다른 이름들:
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위약 비교기: OpSCF Matching-Placebo
Participants received OpSCF matching-placebo, Q2W, SC, up to 14 weeks in the placebo-controlled period.
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Administered SC.
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실험적: 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.
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Administered SC.
다른 이름들:
Administered SC.
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위약 비교기: 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.
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Administered SC.
다른 이름들:
Administered SC.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 16
기간: Baseline, Week 16
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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.
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Baseline, Week 16
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants Who Experienced At-Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Events (SAEs)
기간: From first dose of study drug up to end of follow-up (up to Week 67)
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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.
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From first dose of study drug up to end of follow-up (up to Week 67)
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Percent Change From Baseline in EASI at Weeks 2, 4, 6, 8, 10, 12, and 14
기간: Baseline, Weeks 2, 4, 6, 8, 10, 12 and 14
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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.
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Baseline, Weeks 2, 4, 6, 8, 10, 12 and 14
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Change From Baseline in EASI at Weeks 2, 4, 6, 8, 10, 12, 14, and 16
기간: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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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.
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Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Percentage of Participants Achieving At-Least 50% Improvement From Baseline in EASI (EASI50)
기간: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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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.
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At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Percentage of Participants Achieving At-Least 75% Improvement From Baseline in EASI (EASI75)
기간: 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.
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At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Percentage of Participants Achieving At-Least 90% Improvement From Baseline in EASI (EASI90)
기간: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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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.
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At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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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)
기간: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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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.
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At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Percentage of Participants Achieving At-Least a 2-grade Reduction From Baseline in vIGA-AD
기간: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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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.
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At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Change From Baseline in Weekly Average of the Daily Peak Pruritus Numeric Rating Scale (PP-NRS)
기간: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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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.
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Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Percent Change From Baseline in Weekly Average of the Daily PP-NRS
기간: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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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.
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Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Percentage of Participants Achieving At-Least a 4-point Reduction From Baseline in Weekly Average of the Daily PP-NRS
기간: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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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.
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Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD)
기간: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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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.
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Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Percent Change From Baseline in BSA Involved With AD
기간: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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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.
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Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Change From Baseline in Atopic Dermatitis Control Tool (ADCT) at Weeks 2, 4, 8, 12, and 16
기간: Baseline, Weeks 2, 4, 8,12 and 16
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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.
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Baseline, Weeks 2, 4, 8,12 and 16
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Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Weeks 2, 4, 8, 12, and 16
기간: Baseline, Weeks 2, 4, 8,12 and 16
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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.
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Baseline, Weeks 2, 4, 8,12 and 16
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Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12, and 16
기간: Baseline, Weeks 2, 4, 8,12 and 16
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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.
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Baseline, Weeks 2, 4, 8,12 and 16
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Placebo-controlled Period: Serum Concentrations of OpSCF Over Time
기간: Days 15, 29, 43, 57, 85, 99, 102, 106 and 113
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Days 15, 29, 43, 57, 85, 99, 102, 106 and 113
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OLE Period: Serum Concentrations of OpSCF Over Time
기간: Days 141, 169, 197, 225, 253, 281, 309 and 337
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Days 141, 169, 197, 225, 253, 281, 309 and 337
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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4주차, 8주차, 12주차, 16주차의 혈액 바이오마커 및 IgE의 기준선 대비 변화
기간: 16주
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혈액 검사
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16주
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4주차와 16주차에 피부 생검을 사용하여 수집된 피부 바이오마커의 기준선 대비 변화(동의한 피험자의 경우 선택 사항)
기간: 16주
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조직병리학적 검사
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16주
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4주차와 16주차에 테이프 스트립을 사용하여 수집한 피부 바이오마커의 기준선 대비 변화(동의한 피험자의 경우 선택 사항)
기간: 16주
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단백질체학 및 mRNA 수준 분석
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16주
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Study Director, Insmed Incorporated
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2023년 11월 21일
기본 완료 (실제)
2024년 9월 3일
연구 완료 (실제)
2025년 8월 18일
연구 등록 날짜
최초 제출
2023년 10월 19일
QC 기준을 충족하는 최초 제출
2023년 10월 25일
처음 게시됨 (실제)
2023년 10월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 17일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .