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Фаза 2а: исследование эффективности и безопасности OpSCF при умеренном и тяжелом атопическом дерматите

17 августа 2026 г. обновлено: Insmed Incorporated

Рандомизированное двойное слепое плацебо-контролируемое исследование фазы 2а для оценки эффективности и безопасности OpSCF при лечении взрослых субъектов с атопическим дерматитом средней и тяжелой степени

Цель этого исследования — определить эффективность и безопасность моноклонального антитела OpSCF при лечении взрослых с атопическим дерматитом (экземой) от умеренной до тяжелой степени. OpSCF будут сравнивать с плацебо.

OpSCF или плацебо будут вводиться каждые 2 недели в течение 14 недель, а эффективность будет оцениваться через две недели. После этого субъекты могут выбрать фазу открытого продления, в ходе которой все субъекты будут получать OpSCF каждые 4 недели в течение дополнительных 40 недель.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

50

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Канада
    • Ontario
      • Oshawa, Ontario, Канада, L1H 1B9
        • Oshawa Clinic Dermatology Trials
      • Toronto, Ontario, Канада, M4W 2N2
        • Research Toronto
    • Quebec
      • Montreal, Quebec, Канада, H2X 2V1
        • Innovaderm Research Inc
      • Québec, Quebec, Канада, G1W 4R4
        • Centre de Recherche Saint-Louis
  • Соединенные Штаты
    • Alabama
      • Birmingham, Alabama, Соединенные Штаты, 33607
        • Cahaba Dermatology & Skin Health Center
    • California
      • Fountain Valley, California, Соединенные Штаты, 92708
        • First OC Dermatology Research
      • Inglewood, California, Соединенные Штаты, 90301
        • Axon Clinical Research
      • San Diego, California, Соединенные Штаты, 92123
        • University Clinical Trials
      • Sherman Oaks, California, Соединенные Штаты, 91403
        • Unison Clinical Trials
    • Florida
      • Boca Raton, Florida, Соединенные Штаты, 33456
        • Skin Care Research
      • Miami, Florida, Соединенные Штаты, 33173
        • Skin Research of South Florida
      • Miami Lakes, Florida, Соединенные Штаты, 33014
        • RM Medical Research
      • Tampa, Florida, Соединенные Штаты, 33607
        • Advanced Clinical Research Institute
    • Illinois
      • Rolling Meadows, Illinois, Соединенные Штаты, 60008
        • Arlington Dermatology
    • Indiana
      • West Lafayette, Indiana, Соединенные Штаты, 47906
        • Options Research Group
    • Kentucky
      • Louisville, Kentucky, Соединенные Штаты, 40241
        • DS Research of Kentucky
    • Michigan
      • Auburn Hills, Michigan, Соединенные Штаты, 48326
        • Oakland Hills Dermatology P.C
      • Bay City, Michigan, Соединенные Штаты, 48706
        • Saginaw Bay Dermatology
    • Nevada
      • Reno, Nevada, Соединенные Штаты, 89509
        • Skin Cancer and Dermatology Institute
    • New York
      • Kew Gardens, New York, Соединенные Штаты, 11415
        • Forest Hills Dermatology Group
    • Texas
      • Frisco, Texas, Соединенные Штаты, 75034
        • Rodgers Dermatology
    • Washington
      • Bellevue, Washington, Соединенные Штаты, 98004
        • Dermatology Of Seattle

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Критерии включения:

  • У субъекта клинически подтвержден диагноз активного АД.
  • Субъект имеет как минимум 6-месячную историю болезни Альцгеймера.
  • Субъект готов использовать эффективный контроль над рождаемостью.

Критерий исключения:

  • Субъектом является женщина, кормящая грудью, беременная или планирующая забеременеть во время исследования.
  • У субъекта имеется какое-либо клинически значимое заболевание, которое может подвергнуть субъекта неоправданному риску или помешать интерпретации результатов исследования.
  • Субъект использовал дупилумаб в течение 26 недель до первого дня.
  • Субъект использовал тралокинумаб в течение 12 недель до первого дня.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Биологический: OpSCF
Administered SC.
Другие имена:
  • Humanized IgG4k, SCF248
Плацебо Компаратор: OpSCF Matching-Placebo
Participants received OpSCF matching-placebo, Q2W, SC, up to 14 weeks in the placebo-controlled period.
Биологический: Placebo
Administered SC.
Экспериментальный: 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.
Биологический: OpSCF
Administered SC.
Другие имена:
  • Humanized IgG4k, SCF248
Биологический: Placebo
Administered SC.
Плацебо Компаратор: 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.
Биологический: OpSCF
Administered SC.
Другие имена:
  • Humanized IgG4k, SCF248
Биологический: Placebo
Administered SC.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 16
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Participants Who Experienced At-Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Events (SAEs)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Days 141, 169, 197, 225, 253, 281, 309 and 337
Days 141, 169, 197, 225, 253, 281, 309 and 337

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Изменение биомаркеров крови и IgE по сравнению с исходным уровнем на 4, 8, 12 и 16 неделях.
Временное ограничение: 16 недель
Анализы крови
16 недель
Изменение по сравнению с исходным уровнем кожных биомаркеров, полученных с помощью биопсии кожи на 4-й и 16-й неделях (необязательно для давших согласие субъектов)
Временное ограничение: 16 недель
Гистопатологическое исследование
16 недель
Изменение кожных биомаркеров, собранных с помощью ленточных полосок, по сравнению с исходным уровнем на 4-й и 16-й неделях (необязательно для давших согласие субъектов)
Временное ограничение: 16 недель
Анализ протеомики и уровней мРНК
16 недель

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Insmed Incorporated

Соавторы

Innovaderm Research Inc.

Следователи

  • Директор по исследованиям: Study Director, Insmed Incorporated

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

21 ноября 2023 г.

Первичное завершение (Действительный)

3 сентября 2024 г.

Завершение исследования (Действительный)

18 августа 2025 г.

Даты регистрации исследования

Первый отправленный

19 октября 2023 г.

Впервые представлено, что соответствует критериям контроля качества

25 октября 2023 г.

Первый опубликованный (Действительный)

26 октября 2023 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

11 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

17 августа 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • OpSCF-201

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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