- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT06101823
Vaiheen 2a tutkimus OpSCF:n tehosta ja turvallisuudesta kohtalaisessa tai vaikeassa atooppisessa ihottumassa
Satunnaistettu, kaksoissokkoutettu, lumekontrolloitu, vaiheen 2a tutkimus OpSCF:n tehokkuuden ja turvallisuuden arvioimiseksi keskivaikeasta tai vaikeasta atooppisesta ihottumasta sairastavien aikuispotilaiden hoidossa
Tämän tutkimuksen tarkoituksena on määrittää monoklonaalisen vasta-aineen, OpSCF:n, teho ja turvallisuus keskivaikean tai vaikean atooppisen ihottuman (ekseema) hoidossa aikuisilla. OpSCF:ää verrataan lumelääkkeeseen.
OpSCF:ää tai lumelääkettä annetaan 2 viikon välein 14 viikon ajan, ja teho arvioidaan kahden viikon kuluttua. Tämän jälkeen koehenkilöt voivat halutessaan siirtyä Open Label Extension -vaiheeseen, jossa kaikki koehenkilöt saavat OpSCF:tä 4 viikon välein 40 lisäviikon ajan.
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
-
-
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
-
-
-
-
Alabama
-
Birmingham, Alabama, Yhdysvallat, 33607
- Cahaba Dermatology & Skin Health Center
-
-
California
-
Fountain Valley, California, Yhdysvallat, 92708
- First OC Dermatology Research
-
Inglewood, California, Yhdysvallat, 90301
- Axon Clinical Research
-
San Diego, California, Yhdysvallat, 92123
- University Clinical Trials
-
Sherman Oaks, California, Yhdysvallat, 91403
- Unison Clinical Trials
-
-
Florida
-
Boca Raton, Florida, Yhdysvallat, 33456
- Skin Care Research
-
Miami, Florida, Yhdysvallat, 33173
- Skin Research of South Florida
-
Miami Lakes, Florida, Yhdysvallat, 33014
- RM Medical Research
-
Tampa, Florida, Yhdysvallat, 33607
- Advanced Clinical Research Institute
-
-
Illinois
-
Rolling Meadows, Illinois, Yhdysvallat, 60008
- Arlington Dermatology
-
-
Indiana
-
West Lafayette, Indiana, Yhdysvallat, 47906
- Options Research Group
-
-
Kentucky
-
Louisville, Kentucky, Yhdysvallat, 40241
- DS Research of Kentucky
-
-
Michigan
-
Auburn Hills, Michigan, Yhdysvallat, 48326
- Oakland Hills Dermatology P.C
-
Bay City, Michigan, Yhdysvallat, 48706
- Saginaw Bay Dermatology
-
-
Nevada
-
Reno, Nevada, Yhdysvallat, 89509
- Skin Cancer and Dermatology Institute
-
-
New York
-
Kew Gardens, New York, Yhdysvallat, 11415
- Forest Hills Dermatology Group
-
-
Texas
-
Frisco, Texas, Yhdysvallat, 75034
- Rodgers Dermatology
-
-
Washington
-
Bellevue, Washington, Yhdysvallat, 98004
- Dermatology Of Seattle
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Sisällyttämiskriteerit:
- Potilaalla on kliinisesti vahvistettu aktiivisen AD:n diagnoosi
- Tutkittavalla on vähintään 6 kuukauden AD-historia
- Tutkittava on valmis käyttämään tehokasta ehkäisyä
Poissulkemiskriteerit:
- Kohde on nainen, joka imettää, raskaana tai suunnittelee raskautta tutkimuksen aikana.
- Tutkittavalla on kliinisesti merkittävä sairaus, joka saattaisi koehenkilön kohtuuttoman riskin tai häiritsee tutkimustulosten tulkintaa.
- Koehenkilö on käyttänyt dupilumabia 26 viikon aikana ennen päivää 1
- Koehenkilö on käyttänyt tralokinumabia 12 viikon aikana ennen päivää 1
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
Muut nimet:
|
|
Placebo Comparator: OpSCF Matching-Placebo
Participants received OpSCF matching-placebo, Q2W, SC, up to 14 weeks in the placebo-controlled period.
|
Administered SC.
|
|
Kokeellinen: 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.
Muut nimet:
Administered SC.
|
|
Placebo Comparator: 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.
Muut nimet:
Administered SC.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 16
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of Participants Who Experienced At-Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Events (SAEs)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Days 141, 169, 197, 225, 253, 281, 309 and 337
|
Days 141, 169, 197, 225, 253, 281, 309 and 337
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Muutos lähtötasosta veren biomarkkereissa ja IgE:ssä viikoilla 4, 8, 12 ja 16
Aikaikkuna: 16 viikkoa
|
Verikokeet
|
16 viikkoa
|
|
Muutos lähtötasosta ihobiopsioilla viikoilla 4 ja 16 kerätyissä ihon biomarkkereissa (valinnainen suostumuksella oleville koehenkilöille)
Aikaikkuna: 16 viikkoa
|
Histopatologinen tutkimus
|
16 viikkoa
|
|
Muutos lähtötasosta ihon biomarkkereissa, jotka on kerätty teippiliuskoilla viikoilla 4 ja 16 (valinnainen suostumuksella oleville koehenkilöille)
Aikaikkuna: 16 viikkoa
|
Proteomiikan ja mRNA-tasojen analyysi
|
16 viikkoa
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Opintojohtaja: Study Director, Insmed Incorporated
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Geneettiset sairaudet, synnynnäiset
- Immuunijärjestelmän sairaudet
- Yliherkkyys, välitön
- Yliherkkyys
- Ihosairaudet
- Ihosairaudet, geneettiset
- Ihosairaudet, eksematoottiset
- Dermatiitti
- Synnynnäiset, perinnölliset ja vastasyntyneiden sairaudet ja poikkeavuudet
- Iho- ja sidekudostaudit
- Dermatiitti, atooppinen
- Ekseema
Muut tutkimustunnusnumerot
- OpSCF-201
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .