中等度から重度のアトピー性皮膚炎におけるOpSCFの有効性と安全性に関する第2a相研究
2026年8月17日 更新者：Insmed Incorporated
中等度から重度のアトピー性皮膚炎の成人被験者の治療における OpSCF の有効性と安全性を評価するためのランダム化二重盲検プラセボ対照第 2a 相試験
この研究の目的は、中等度から重度のアトピー性皮膚炎（湿疹）を患う成人の治療におけるモノクローナル抗体 OpSCF の有効性と安全性を確認することです。 OpSCF はプラセボと比較されます。
OpSCFまたはプラセボは14週間にわたって2週間ごとに投与され、2週間後に有効性が評価されます。 その後、被験者はオープンラベル延長フェーズに入る選択をすることができ、このフェーズではすべての被験者がさらに 40 週間にわたり 4 週間ごとに OpSCF を受けることになります。
調査の概要
研究の種類
介入
入学 (実際)
50
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、33607
- Cahaba Dermatology & Skin Health Center
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California
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Fountain Valley、California、アメリカ、92708
- First OC Dermatology Research
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Inglewood、California、アメリカ、90301
- Axon Clinical Research
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San Diego、California、アメリカ、92123
- University Clinical Trials
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Sherman Oaks、California、アメリカ、91403
- Unison Clinical Trials
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Florida
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Boca Raton、Florida、アメリカ、33456
- Skin Care Research
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Miami、Florida、アメリカ、33173
- Skin Research of South Florida
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Miami Lakes、Florida、アメリカ、33014
- RM Medical Research
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Tampa、Florida、アメリカ、33607
- Advanced Clinical Research Institute
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Illinois
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Rolling Meadows、Illinois、アメリカ、60008
- Arlington Dermatology
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Indiana
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West Lafayette、Indiana、アメリカ、47906
- Options Research Group
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Kentucky
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Louisville、Kentucky、アメリカ、40241
- DS Research of Kentucky
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Michigan
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Auburn Hills、Michigan、アメリカ、48326
- Oakland Hills Dermatology P.C
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Bay City、Michigan、アメリカ、48706
- Saginaw Bay Dermatology
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Nevada
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Reno、Nevada、アメリカ、89509
- Skin Cancer and Dermatology Institute
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New York
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Kew Gardens、New York、アメリカ、11415
- Forest Hills Dermatology Group
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Texas
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Frisco、Texas、アメリカ、75034
- Rodgers Dermatology
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Washington
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Bellevue、Washington、アメリカ、98004
- Dermatology Of Seattle
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Ontario
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Oshawa、Ontario、カナダ、L1H 1B9
- Oshawa Clinic Dermatology Trials
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Toronto、Ontario、カナダ、M4W 2N2
- Research Toronto
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Quebec
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Montreal、Quebec、カナダ、H2X 2V1
- Innovaderm Research Inc
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Québec、Quebec、カナダ、G1W 4R4
- Centre de Recherche Saint-Louis
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- 被験者は活動性ADの診断が臨床的に確認されている
- 被験者は少なくとも6か月のAD病歴がある
- 被験者は効果的な避妊を行うことに意欲的である
除外基準:
- 対象は授乳中、妊娠中、または研究中に妊娠を計画している女性です。
- 被験者は、被験者を過度の危険にさらす、または研究結果の解釈を妨げる臨床的に重大な病状を患っている。
- 被験者は1日目から26週間以内にデュピルマブを使用したことがある
- 被験者は1日目までの12週間以内にトラロキヌマブを使用したことがある
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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Administered SC.
他の名前：
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プラセボコンパレーター：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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実験的：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.
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Administered SC.
他の名前：
Administered SC.
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プラセボコンパレーター：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.
他の名前：
Administered SC.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 16
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants Who Experienced At-Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Events (SAEs)
時間枠：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.
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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
時間枠：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.
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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
時間枠：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.
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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)
時間枠：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.
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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)
時間枠：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)
時間枠：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.
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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)
時間枠：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.
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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
時間枠：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.
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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)
時間枠：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.
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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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
|
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Change From Baseline in Atopic Dermatitis Control Tool (ADCT) at Weeks 2, 4, 8, 12, and 16
時間枠：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
時間枠：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
|
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Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12, and 16
時間枠：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
|
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Placebo-controlled Period: Serum Concentrations of OpSCF Over Time
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
4、8、12、16週目の血液バイオマーカーとIgEのベースラインからの変化
時間枠：16週間
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血液検査
|
16週間
|
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4週目および16週目に皮膚生検を使用して収集された皮膚バイオマーカーのベースラインからの変化（同意のある被験者の場合はオプション）
時間枠：16週間
|
病理組織学的検査
|
16週間
|
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4週目および16週目にテープストリップを使用して収集された皮膚バイオマーカーのベースラインからの変化（同意のある被験者の場合はオプション）
時間枠：16週間
|
プロテオミクスとmRNAレベルの解析
|
16週間
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Study Director、Insmed Incorporated
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2023年11月21日
一次修了 (実際)
2024年9月3日
研究の完了 (実際)
2025年8月18日
試験登録日
最初に提出
2023年10月19日
QC基準を満たした最初の提出物
2023年10月25日
最初の投稿 (実際)
2023年10月26日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月11日
QC基準を満たした最後の更新が送信されました
2026年8月17日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- OpSCF-201
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。