Fas 2a-studie av effektivitet och säkerhet för OpSCF vid måttlig till svår atopisk dermatit
17 augusti 2026 uppdaterad av: Insmed Incorporated
En randomiserad, dubbelblind, placebokontrollerad, fas 2a-studie för att utvärdera effektiviteten och säkerheten av OpSCF vid behandling av vuxna patienter med måttlig till svår atopisk dermatit
Syftet med denna studie är att fastställa effektiviteten och säkerheten hos en monoklonal antikropp, OpSCF, vid behandling av vuxna med måttlig till svår atopisk dermatit (eksem). OpSCF kommer att jämföras med placebo.
OpSCF eller placebo kommer att administreras varannan vecka i 14 veckor, och effekten kommer att bedömas två veckor senare. Efter det kan försökspersoner välja att gå in i en Open Label Extension-fas där alla försökspersoner kommer att få OpSCF var fjärde vecka i ytterligare 40 veckor.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
50
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Alabama
-
Birmingham, Alabama, Förenta staterna, 33607
- Cahaba Dermatology & Skin Health Center
-
-
California
-
Fountain Valley, California, Förenta staterna, 92708
- First OC Dermatology Research
-
Inglewood, California, Förenta staterna, 90301
- Axon Clinical Research
-
San Diego, California, Förenta staterna, 92123
- University Clinical Trials
-
Sherman Oaks, California, Förenta staterna, 91403
- Unison Clinical Trials
-
-
Florida
-
Boca Raton, Florida, Förenta staterna, 33456
- Skin Care Research
-
Miami, Florida, Förenta staterna, 33173
- Skin Research of South Florida
-
Miami Lakes, Florida, Förenta staterna, 33014
- RM Medical Research
-
Tampa, Florida, Förenta staterna, 33607
- Advanced Clinical Research Institute
-
-
Illinois
-
Rolling Meadows, Illinois, Förenta staterna, 60008
- Arlington Dermatology
-
-
Indiana
-
West Lafayette, Indiana, Förenta staterna, 47906
- Options Research Group
-
-
Kentucky
-
Louisville, Kentucky, Förenta staterna, 40241
- DS Research of Kentucky
-
-
Michigan
-
Auburn Hills, Michigan, Förenta staterna, 48326
- Oakland Hills Dermatology P.C
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Bay City, Michigan, Förenta staterna, 48706
- Saginaw Bay Dermatology
-
-
Nevada
-
Reno, Nevada, Förenta staterna, 89509
- Skin Cancer and Dermatology Institute
-
-
New York
-
Kew Gardens, New York, Förenta staterna, 11415
- Forest Hills Dermatology Group
-
-
Texas
-
Frisco, Texas, Förenta staterna, 75034
- Rodgers Dermatology
-
-
Washington
-
Bellevue, Washington, Förenta staterna, 98004
- Dermatology Of Seattle
-
-
-
-
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
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inklusionskriterier:
- Försökspersonen har kliniskt bekräftad diagnos av aktiv AD
- Ämnet har minst 6 månaders historia av AD
- Försökspersonen är villig att använda effektiv preventivmedel
Exklusions kriterier:
- Försökspersonen är en kvinna som ammar, är gravid eller planerar att bli gravid under studien.
- Försökspersonen har något kliniskt signifikant medicinskt tillstånd som skulle sätta försökspersonen i onödig risk eller störa tolkningen av studieresultaten.
- Försökspersonen har använt dupilumab inom 26 veckor före dag 1
- Personen har använt tralokinumab inom 12 veckor före dag 1
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Administered SC.
Andra namn:
|
|
Placebo-jämförare: OpSCF Matching-Placebo
Participants received OpSCF matching-placebo, Q2W, SC, up to 14 weeks in the placebo-controlled period.
|
Administered SC.
|
|
Experimentell: 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.
Andra namn:
Administered SC.
|
|
Placebo-jämförare: 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.
Andra namn:
Administered SC.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 16
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants Who Experienced At-Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Events (SAEs)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Days 141, 169, 197, 225, 253, 281, 309 and 337
|
Days 141, 169, 197, 225, 253, 281, 309 and 337
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Förändring från baslinjen i blodbiomarkörer och IgE vid vecka 4, 8, 12 och 16
Tidsram: 16 veckor
|
Blodprov
|
16 veckor
|
|
Förändring från baslinjen i hudbiomarkörer som samlats in med hudbiopsier vid vecka 4 och 16 (valfritt för samtycke)
Tidsram: 16 veckor
|
Histopatologisk undersökning
|
16 veckor
|
|
Förändring från baslinjen i hudbiomarkörer som samlats in med tejpremsor vid vecka 4 och 16 (valfritt för samtycke)
Tidsram: 16 veckor
|
Analys av proteomik och mRNA-nivåer
|
16 veckor
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Study Director, Insmed Incorporated
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
21 november 2023
Primärt slutförande (Faktisk)
3 september 2024
Avslutad studie (Faktisk)
18 augusti 2025
Studieregistreringsdatum
Först inskickad
19 oktober 2023
Först inskickad som uppfyllde QC-kriterierna
25 oktober 2023
Första postat (Faktisk)
26 oktober 2023
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- OpSCF-201
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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