Fase 2a-onderzoek naar de werkzaamheid en veiligheid van OpSCF bij matige tot ernstige atopische dermatitis
17 augustus 2026 bijgewerkt door: Insmed Incorporated
Een gerandomiseerde, dubbelblinde, placebogecontroleerde fase 2a-studie om de werkzaamheid en veiligheid van OpSCF te evalueren bij de behandeling van volwassen proefpersonen met matige tot ernstige atopische dermatitis
Het doel van deze studie is het bepalen van de werkzaamheid en veiligheid van een monoklonaal antilichaam, OpSCF, bij de behandeling van volwassenen met matige tot ernstige atopische dermatitis (eczeem). OpSCF zal worden vergeleken met een placebo.
OpSCF of placebo wordt gedurende 14 weken elke twee weken toegediend en de werkzaamheid wordt twee weken later beoordeeld. Daarna kunnen proefpersonen ervoor kiezen om een Open Label Extensiefase in te gaan, waarin alle proefpersonen gedurende 40 extra weken elke 4 weken OpSCF zullen ontvangen.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
50
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ontario
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Oshawa, Ontario, Canada, L1H 1B9
- Oshawa Clinic Dermatology Trials
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Toronto, Ontario, Canada, M4W 2N2
- Research Toronto
-
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Quebec
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Montreal, Quebec, Canada, H2X 2V1
- Innovaderm Research Inc
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Québec, Quebec, Canada, G1W 4R4
- Centre de Recherche Saint-Louis
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Alabama
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Birmingham, Alabama, Verenigde Staten, 33607
- Cahaba Dermatology & Skin Health Center
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California
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Fountain Valley, California, Verenigde Staten, 92708
- First OC Dermatology Research
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Inglewood, California, Verenigde Staten, 90301
- Axon Clinical Research
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San Diego, California, Verenigde Staten, 92123
- University Clinical Trials
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Sherman Oaks, California, Verenigde Staten, 91403
- Unison Clinical Trials
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Florida
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Boca Raton, Florida, Verenigde Staten, 33456
- Skin Care Research
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Miami, Florida, Verenigde Staten, 33173
- Skin Research of South Florida
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Miami Lakes, Florida, Verenigde Staten, 33014
- RM Medical Research
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Tampa, Florida, Verenigde Staten, 33607
- Advanced Clinical Research Institute
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Illinois
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Rolling Meadows, Illinois, Verenigde Staten, 60008
- Arlington Dermatology
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Indiana
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West Lafayette, Indiana, Verenigde Staten, 47906
- Options Research Group
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Kentucky
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Louisville, Kentucky, Verenigde Staten, 40241
- DS Research of Kentucky
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Michigan
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Auburn Hills, Michigan, Verenigde Staten, 48326
- Oakland Hills Dermatology P.C
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Bay City, Michigan, Verenigde Staten, 48706
- Saginaw Bay Dermatology
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Nevada
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Reno, Nevada, Verenigde Staten, 89509
- Skin Cancer and Dermatology Institute
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New York
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Kew Gardens, New York, Verenigde Staten, 11415
- Forest Hills Dermatology Group
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Texas
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Frisco, Texas, Verenigde Staten, 75034
- Rodgers Dermatology
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Washington
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Bellevue, Washington, Verenigde Staten, 98004
- Dermatology Of Seattle
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusiecriteria:
- De proefpersoon heeft een klinisch bevestigde diagnose van actieve AD
- De proefpersoon heeft een voorgeschiedenis van AD van ten minste zes maanden
- De proefpersoon is bereid effectieve anticonceptie toe te passen
Uitsluitingscriteria:
- De proefpersoon is een vrouw die borstvoeding geeft, zwanger is of van plan is zwanger te worden tijdens het onderzoek.
- De proefpersoon heeft een klinisch significante medische aandoening waardoor de proefpersoon een onnodig risico loopt of de interpretatie van de onderzoeksresultaten wordt verstoord.
- Proefpersoon heeft dupilumab gebruikt binnen 26 weken voorafgaand aan dag 1
- De proefpersoon heeft tralokinumab gebruikt binnen 12 weken voorafgaand aan dag 1
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
Andere namen:
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Placebo-vergelijker: 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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Experimenteel: OpSCF 600 mg/OpSCF 600mg
Participants who received OpSCF 600 mg and completed placebo-controlled treatment received OpSCF 600mg, once every 4 weeks (Q4W), SC, up to 36 weeks in the open-label extension (OLE) period.
|
Administered SC.
Andere namen:
Administered SC.
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Placebo-vergelijker: OpSCF Matching-Placebo/OpSCF 600 mg
Participants who received OpSCF matching-placebo and completed placebo-controlled treatment received OpSCF 600mg, Q4W, SC, up to 36 weeks in the OLE period.
|
Administered SC.
Andere namen:
Administered SC.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 16
Tijdsspanne: 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.
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Baseline, Week 16
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Participants Who Experienced At-Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Events (SAEs)
Tijdsspanne: 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
Tijdsspanne: 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
|
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Change From Baseline in EASI at Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Tijdsspanne: 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
|
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Percentage of Participants Achieving At-Least 50% Improvement From Baseline in EASI (EASI50)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
|
Percentage of Participants Achieving At-Least a 2-grade Reduction From Baseline in vIGA-AD
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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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Percent Change From Baseline in BSA Involved With AD
Tijdsspanne: 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
Tijdsspanne: 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
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Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Weeks 2, 4, 8, 12, and 16
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Days 15, 29, 43, 57, 85, 99, 102, 106 and 113
|
Days 15, 29, 43, 57, 85, 99, 102, 106 and 113
|
|
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OLE Period: Serum Concentrations of OpSCF Over Time
Tijdsspanne: Days 141, 169, 197, 225, 253, 281, 309 and 337
|
Days 141, 169, 197, 225, 253, 281, 309 and 337
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Verandering ten opzichte van de uitgangswaarde in bloedbiomarkers en IgE in week 4, 8, 12 en 16
Tijdsspanne: 16 weken
|
Bloedtesten
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16 weken
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Verandering ten opzichte van de uitgangswaarde in huidbiomarkers verzameld met behulp van huidbiopten in week 4 en 16 (optioneel voor instemmende proefpersonen)
Tijdsspanne: 16 weken
|
Histopathologisch onderzoek
|
16 weken
|
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Verandering ten opzichte van de uitgangswaarde in huidbiomarkers verzameld met behulp van tapestrips in week 4 en 16 (optioneel voor instemmende proefpersonen)
Tijdsspanne: 16 weken
|
Analyse van proteomics en mRNA-niveaus
|
16 weken
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Study Director, Insmed Incorporated
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
21 november 2023
Primaire voltooiing (Werkelijk)
3 september 2024
Studie voltooiing (Werkelijk)
18 augustus 2025
Studieregistratiedata
Eerst ingediend
19 oktober 2023
Eerst ingediend dat voldeed aan de QC-criteria
25 oktober 2023
Eerst geplaatst (Werkelijk)
26 oktober 2023
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 september 2026
Laatste update ingediend die voldeed aan QC-criteria
17 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- OpSCF-201
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .