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Badanie fazy 2a skuteczności i bezpieczeństwa OpSCF w leczeniu umiarkowanego do ciężkiego atopowego zapalenia skóry

17 sierpnia 2026 zaktualizowane przez: Insmed Incorporated

Randomizowane, podwójnie ślepe, kontrolowane placebo badanie fazy 2a oceniające skuteczność i bezpieczeństwo OpSCF w leczeniu dorosłych pacjentów z umiarkowanym do ciężkiego atopowym zapaleniem skóry

Celem tego badania jest określenie skuteczności i bezpieczeństwa przeciwciała monoklonalnego OpSCF w leczeniu osób dorosłych z umiarkowanym do ciężkiego atopowym zapaleniem skóry (egzemą). OpSCF zostanie porównany z placebo.

OpSCF lub placebo będą podawane co 2 tygodnie przez 14 tygodni, a skuteczność będzie oceniana dwa tygodnie później. Następnie uczestnicy mogą zdecydować się na fazę przedłużenia badania Open Label, podczas której wszyscy uczestnicy będą otrzymywać OpSCF co 4 tygodnie przez dodatkowe 40 tygodni.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

50

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Kryteria przyjęcia:

  • Pacjent ma klinicznie potwierdzoną diagnozę aktywnej choroby Alzheimera
  • Pacjent ma co najmniej 6-miesięczną historię AD
  • Podmiot wyraża chęć stosowania skutecznej kontroli urodzeń

Kryteria wyłączenia:

  • Uczestnikiem jest kobieta karmiąca piersią, będąca w ciąży lub planująca zajście w ciążę w trakcie badania.
  • U uczestnika występuje jakikolwiek klinicznie istotny stan chorobowy, który narażałby go na nadmierne ryzyko lub zakłócał interpretację wyników badania.
  • Uczestnik stosował dupilumab w ciągu 26 tygodni poprzedzających dzień 1
  • Uczestnik stosował tralokinumab w ciągu 12 tygodni poprzedzających dzień 1

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Biologiczny: OpSCF
Administered SC.
Inne nazwy:
  • Humanized IgG4k, SCF248
Komparator placebo: OpSCF Matching-Placebo
Participants received OpSCF matching-placebo, Q2W, SC, up to 14 weeks in the placebo-controlled period.
Biologiczny: Placebo
Administered SC.
Eksperymentalny: 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.
Biologiczny: OpSCF
Administered SC.
Inne nazwy:
  • Humanized IgG4k, SCF248
Biologiczny: Placebo
Administered SC.
Komparator placebo: 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.
Biologiczny: OpSCF
Administered SC.
Inne nazwy:
  • Humanized IgG4k, SCF248
Biologiczny: Placebo
Administered SC.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 16
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants Who Experienced At-Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Events (SAEs)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Days 141, 169, 197, 225, 253, 281, 309 and 337
Days 141, 169, 197, 225, 253, 281, 309 and 337

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Zmiana biomarkerów krwi i IgE w stosunku do wartości wyjściowych w tygodniach 4, 8, 12 i 16
Ramy czasowe: 16 tygodni
Badania krwi
16 tygodni
Zmiana w stosunku do wartości wyjściowych w zakresie biomarkerów skóry zebranych podczas biopsji skóry w 4. i 16. tygodniu (opcjonalnie w przypadku osób, które wyraziły zgodę)
Ramy czasowe: 16 tygodni
Badanie histopatologiczne
16 tygodni
Zmiana w porównaniu z wartością wyjściową w biomarkerach skóry zebranych za pomocą pasków taśmy w tygodniach 4 i 16 (opcjonalnie w przypadku osób, które wyraziły zgodę)
Ramy czasowe: 16 tygodni
Analiza poziomu proteomiki i mRNA
16 tygodni

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Insmed Incorporated

Współpracownicy

Innovaderm Research Inc.

Śledczy

  • Dyrektor Studium: Study Director, Insmed Incorporated

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

21 listopada 2023

Zakończenie podstawowe (Rzeczywisty)

3 września 2024

Ukończenie studiów (Rzeczywisty)

18 sierpnia 2025

Daty rejestracji na studia

Pierwszy przesłany

19 października 2023

Pierwszy przesłany, który spełnia kryteria kontroli jakości

25 października 2023

Pierwszy wysłany (Rzeczywisty)

26 października 2023

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

11 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • OpSCF-201

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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