Fáze 2a studie účinnosti a bezpečnosti OpSCF u středně těžké až těžké atopické dermatitidy
17. srpna 2026 aktualizováno: Insmed Incorporated
Randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie fáze 2a k vyhodnocení účinnosti a bezpečnosti OpSCF při léčbě dospělých pacientů se středně těžkou až těžkou atopickou dermatitidou
Účelem této studie je stanovit účinnost a bezpečnost monoklonální protilátky, OpSCF, při léčbě dospělých se středně těžkou až těžkou atopickou dermatitidou (ekzémem). OpSCF bude srovnáván s placebem.
OpSCF nebo placebo budou podávány každé 2 týdny po dobu 14 týdnů a účinnost bude hodnocena o dva týdny později. Poté se subjekty mohou rozhodnout vstoupit do fáze Open Label Extension, ve které budou všechny subjekty dostávat OpSCF každé 4 týdny po dobu dalších 40 týdnů.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
50
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Ontario
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Oshawa, Ontario, Kanada, L1H 1B9
- Oshawa Clinic Dermatology Trials
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Toronto, Ontario, Kanada, M4W 2N2
- Research Toronto
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Quebec
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Montreal, Quebec, Kanada, H2X 2V1
- Innovaderm Research Inc
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Québec, Quebec, Kanada, G1W 4R4
- Centre de Recherche Saint-Louis
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Alabama
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Birmingham, Alabama, Spojené státy, 33607
- Cahaba Dermatology & Skin Health Center
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California
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Fountain Valley, California, Spojené státy, 92708
- First OC Dermatology Research
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Inglewood, California, Spojené státy, 90301
- Axon Clinical Research
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San Diego, California, Spojené státy, 92123
- University Clinical Trials
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Sherman Oaks, California, Spojené státy, 91403
- Unison Clinical Trials
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Florida
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Boca Raton, Florida, Spojené státy, 33456
- Skin Care Research
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Miami, Florida, Spojené státy, 33173
- Skin Research of South Florida
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Miami Lakes, Florida, Spojené státy, 33014
- RM Medical Research
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Tampa, Florida, Spojené státy, 33607
- Advanced Clinical Research Institute
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Illinois
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Rolling Meadows, Illinois, Spojené státy, 60008
- Arlington Dermatology
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Indiana
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West Lafayette, Indiana, Spojené státy, 47906
- Options Research Group
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Kentucky
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Louisville, Kentucky, Spojené státy, 40241
- DS Research of Kentucky
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Michigan
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Auburn Hills, Michigan, Spojené státy, 48326
- Oakland Hills Dermatology P.C
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Bay City, Michigan, Spojené státy, 48706
- Saginaw Bay Dermatology
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Nevada
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Reno, Nevada, Spojené státy, 89509
- Skin Cancer and Dermatology Institute
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New York
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Kew Gardens, New York, Spojené státy, 11415
- Forest Hills Dermatology Group
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Texas
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Frisco, Texas, Spojené státy, 75034
- Rodgers Dermatology
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Washington
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Bellevue, Washington, Spojené státy, 98004
- Dermatology Of Seattle
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Kritéria pro zařazení:
- Subjekt má klinicky potvrzenou diagnózu aktivní AD
- Subjekt má alespoň 6měsíční anamnézu AD
- Subjekt je ochoten používat účinnou antikoncepci
Kritéria vyloučení:
- Subjektem je žena, která kojí, je těhotná nebo plánuje otěhotnět během studie.
- Subjekt má jakýkoli klinicky významný zdravotní stav, který by jej vystavil nepřiměřenému riziku nebo interferoval s interpretací výsledků studie.
- Subjekt použil dupilumab během 26 týdnů před dnem 1
- Subjekt použil tralokinumab během 12 týdnů před 1. dnem
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
Ostatní jména:
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Komparátor placeba: 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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Experimentální: OpSCF 600 mg/OpSCF 600mg
Participants who received OpSCF 600 mg and completed placebo-controlled treatment received OpSCF 600mg, once every 4 weeks (Q4W), SC, up to 36 weeks in the open-label extension (OLE) period.
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Administered SC.
Ostatní jména:
Administered SC.
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Komparátor placeba: 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.
Ostatní jména:
Administered SC.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 16
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Participants Who Experienced At-Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Events (SAEs)
Časové okno: From first dose of study drug up to end of follow-up (up to Week 67)
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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
Časové okno: Baseline, Weeks 2, 4, 6, 8, 10, 12 and 14
|
The EASI quantifies the severity of a participant's AD based on both lesion severity and the % of body surface area (BSA) affected.
Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe.
EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) and 6(90 to 100%).
The EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al.
Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD.
Here, a negative change from baseline indicates less severity in AD.
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Baseline, Weeks 2, 4, 6, 8, 10, 12 and 14
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Change From Baseline in EASI at Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Časové okno: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
The EASI quantifies the severity of a participant's AD based on both lesion severity and the % of body surface area (BSA) affected.
Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe.
EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) and 6(90 to 100%).
The EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al.
Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD.
Here, a negative change from baseline indicates less severity in AD.
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Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Percentage of Participants Achieving At-Least 50% Improvement From Baseline in EASI (EASI50)
Časové okno: 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)
Časové okno: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
The EASI quantifies severity of a participant's AD based on both lesion severity & % of body surface area (BSA) affected.
Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0=absent; 1=mild; 2=moderate; 3=severe.
EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) & 6(90 to 100%).
EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al.
Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD.
Here, a negative change from baseline indicates less severity in AD.
EASI 75 response was defined as at least a 75% improvement in EASI relative to Baseline.
90% CI was based on exact Clopper-Pearson method.
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At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
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Percentage of Participants Achieving At-Least 90% Improvement From Baseline in EASI (EASI90)
Časové okno: 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)
Časové okno: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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The vIGA-AD was assessed by the principal investigator or sub-investigator using the descriptors that best described the overall appearance of the lesions.
It is a 5-point morphological assessment of overall disease severity that ranges from 0 to 4, where 0 = Clear; No inflammatory signs of atopic dermatitis 1 = Almost clear; Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification 2 = Mild; Slight but definite erythema (pink), slight but definite induration/papulation, and/ or slight but definite lichenification 3 = Moderate; Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification 4 = Severe; Marked erythema (deep or bright red), marked induration/ papulation, and/or marked lichenification.
Percentage of participants who achieved at least a 2-grade reduction from baseline to clear (0) or Almost Clear (1) in vIGA-AD are reported here.
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At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Percentage of Participants Achieving At-Least a 2-grade Reduction From Baseline in vIGA-AD
Časové okno: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
The vIGA-AD was assessed by the principal investigator or sub-investigator using the descriptors that best described the overall appearance of the lesions.
It is a 5-point morphological assessment of overall disease severity that ranges from 0 to 4, where 0 = Clear; No inflammatory signs of atopic dermatitis 1 = Almost clear; Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification 2 = Mild; Slight but definite erythema (pink), slight but definite induration/papulation, and/ or slight but definite lichenification 3 = Moderate; Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification 4 = Severe; Marked erythema (deep or bright red), marked induration/ papulation, and/or marked lichenification.
The percentage of participants with reduction from baseline of ≥2 grade in vIGA-AD score has been reported.
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At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Change From Baseline in Weekly Average of the Daily Peak Pruritus Numeric Rating Scale (PP-NRS)
Časové okno: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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PP-NRS is based on the Numeric Rating Scale which was used to assess the level of itch the participant was experiencing.
The following question was asked to participants: "On a scale of 0 to 10, with 0 = "no itch" and 10 = "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?"
Based on the score provided by participant, the PP-NRS score was assigned.
Higher score indicates more severity.
A negative change from baseline indicates improvement.
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Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Percent Change From Baseline in Weekly Average of the Daily PP-NRS
Časové okno: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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PP-NRS is based on the Numeric Rating Scale which was used to assess the level of itch the participant was experiencing.
The following question was asked to participants: "On a scale of 0 to 10, with 0 = "no itch" and 10 = "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?"
Based on the score provided by participant, the PP-NRS score was assigned.
Higher score indicates more severity.
A negative change from baseline indicates improvement.
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Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
|
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Percentage of Participants Achieving At-Least a 4-point Reduction From Baseline in Weekly Average of the Daily PP-NRS
Časové okno: 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.
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Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD)
Časové okno: 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.
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Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
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Percent Change From Baseline in BSA Involved With AD
Časové okno: 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.
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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
Časové okno: Baseline, Weeks 2, 4, 8,12 and 16
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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.
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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
Časové okno: Baseline, Weeks 2, 4, 8,12 and 16
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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.
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Baseline, Weeks 2, 4, 8,12 and 16
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Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12, and 16
Časové okno: Baseline, Weeks 2, 4, 8,12 and 16
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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.
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Baseline, Weeks 2, 4, 8,12 and 16
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Placebo-controlled Period: Serum Concentrations of OpSCF Over Time
Časové okno: Days 15, 29, 43, 57, 85, 99, 102, 106 and 113
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Days 15, 29, 43, 57, 85, 99, 102, 106 and 113
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OLE Period: Serum Concentrations of OpSCF Over Time
Časové okno: Days 141, 169, 197, 225, 253, 281, 309 and 337
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Days 141, 169, 197, 225, 253, 281, 309 and 337
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Změna od výchozí hodnoty v krevních biomarkerech a IgE ve 4., 8., 12. a 16. týdnu
Časové okno: 16 týdnů
|
Krevní testy
|
16 týdnů
|
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Změna od výchozí hodnoty v kožních biomarkerech odebraných pomocí kožních biopsií ve 4. a 16. týdnu (volitelné pro souhlasné subjekty)
Časové okno: 16 týdnů
|
Histopatologické vyšetření
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16 týdnů
|
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Změna oproti výchozí hodnotě v kožních biomarkerech odebraných pomocí páskových proužků ve 4. a 16. týdnu (volitelné pro souhlasné subjekty)
Časové okno: 16 týdnů
|
Analýza hladin proteomiky a mRNA
|
16 týdnů
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Study Director, Insmed Incorporated
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
21. listopadu 2023
Primární dokončení (Aktuální)
3. září 2024
Dokončení studie (Aktuální)
18. srpna 2025
Termíny zápisu do studia
První předloženo
19. října 2023
První předloženo, které splnilo kritéria kontroly kvality
25. října 2023
První zveřejněno (Aktuální)
26. října 2023
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
11. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
17. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- OpSCF-201
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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