Tapinarof til behandling af plakpsoriasis hos pædiatriske forsøgspersoner
4. november 2026 opdateret af: Organon and Co
Et fase 3-studie af Tapinarof til behandling af plakpsoriasis hos pædiatriske forsøgspersoner
This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is an open-label study, consisting of a 12-week primary treatment phase and an optional 40-week long-term extension phase in which all eligible subjects will receive tapinarof cream, 1% once daily. At the end of the 12-week primary treatment phase subjects will have the option to continue for 40 additional weeks of treatment. Subjects who choose not to participate in the optional 40-week long-term extension phase will complete a follow-up visit approximately one week after the end of the primary treatment phase.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
58
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Alberta
-
Calgary, Alberta, Canada, T2J7E1
- Dermatology Research Institute Inc.
-
Edmonton, Alberta, Canada, T5J3S9
- Rejuvenation Laser Dermatology Clinics
-
-
Newfoundland and Labrador
-
St. John's, Newfoundland and Labrador, Canada, A1E1V4
- Skincare Studio INC
-
-
Ontario
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Markham, Ontario, Canada, L3P1X3
- Lynderm Research Inc.
-
Waterloo, Ontario, Canada, N2J 1C4
- Alliance Clinical Trials
-
Whitby, Ontario, Canada, L1P0P9
- Whitby Health Centre Dermatology Trials
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 2V1
- Innovaderm Research, Inc.
-
-
-
-
Arkansas
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Rogers, Arkansas, Forenede Stater, 72758
- Northwest Arkansas Clinical Trials Center, PLLC
-
-
California
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Fountain Valley, California, Forenede Stater, 92708
- First OC Dermatology
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Rancho Santa Margarita, California, Forenede Stater, 92688
- Mission Dermatology Center
-
-
Florida
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Miami Lakes, Florida, Forenede Stater, 33014
- San Marcus Research Clinic, Inc.
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Miami Lakes, Florida, Forenede Stater, 33014
- RM Medical Research
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Tampa, Florida, Forenede Stater, 33615
- Olympian Clinical Research
-
-
Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University Feinberg School of Medicine
-
-
Indiana
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Indianapolis, Indiana, Forenede Stater, 46250
- Dawes Fretzin Clinical Research Group
-
West Lafayette, Indiana, Forenede Stater, 47906
- Options Research Group
-
-
Ohio
-
Fairborn, Ohio, Forenede Stater, 45324
- Wright State Physicians Pharmacology Translational Unit
-
-
Oregon
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Portland, Oregon, Forenede Stater, 97210
- Oregon Dermatology & Research Center
-
-
Washington
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Spokane, Washington, Forenede Stater, 99202
- Dermatology Specialists of Spokane
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
2 år til 17 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male and female subjects ages 2 to 17 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 3 months prior to the baseline visit
- Subject with plaque psoriasis covering ≥ 3% of the BSA at screening and baseline
- A PGA score of ≥ 2 at screening and baseline
- Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
- Must not be pregnant
- Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent
Exclusion Criteria:
- Psoriasis other than plaque variant
- Any sign of infection of any of the psoriatic lesions
- Immunocompromised at screening
- Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN)
- Screening total bilirubin > 1.5x ULN
- Current or chronic history of liver disease
- Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
- Major surgery within 8 weeks prior to baseline or has a major surgery planned during the study
- Known history of clinically significant drug or alcohol abuse in the last year prior to baseline
- Use of any prohibited medication or procedure within the indicated period before the baseline visit until the completion of the study completion or study discontinuation
- History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion may interfere with the subject's participation in the study, interpretation of results, safety of the subject or ability to understand and give informed consent
- Pregnant or lactating females.
- History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation
- Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Åbn Label
|
applied topically once daily |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Antal forsøgspersoner med klinisk signifikante abnormiteter i laboratorietest
Tidsramme: Fremvisning op til uge 53
|
Fremvisning op til uge 53
|
|
|
Antal forsøgspersoner med klinisk signifikante abnormiteter i vitale tegn
Tidsramme: Fremvisning op til uge 53
|
Fremvisning op til uge 53
|
|
|
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Screening up to Week 53
|
Incidence, frequency, and duration of treatment emergent AEs and SAEs |
Screening up to Week 53
|
|
Investigator-Assessed Local Tolerability Scale (LTS) Scores
Tidsramme: Baseline up to Week 52
|
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation. |
Baseline up to Week 52
|
|
Subject (or Caregiver)-Assessed Local Tolerability Scale (LTS)
Tidsramme: Baseline up to Week 52
|
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation. |
Baseline up to Week 52
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Detectable Time-Point (AUC0-t) of tapinarof cream, 1%.
Tidsramme: Week 4 and Week 12
|
Area under the plasma concentration-time curve from time zero to the last quantifiable time point. |
Week 4 and Week 12
|
|
Maximum Plasma Concentration (Cmax) of tapinarof cream, 1%.
Tidsramme: Week 4 and Week 12
|
Maximum observed plasma concentration (Cmax). |
Week 4 and Week 12
|
|
Time to Maximum Plasma Concentration (tmax) of tapinarof cream, 1%.
Tidsramme: Week 4 and Week 12
|
Time to maximum observed plasma concentration obtained directly from the observed concentration. |
Week 4 and Week 12
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Clinical Lead Late-Stage Clinical Development, Organon and Co
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. december 2021
Primær færdiggørelse (Faktiske)
14. oktober 2026
Studieafslutning (Faktiske)
14. oktober 2026
Datoer for studieregistrering
Først indsendt
28. oktober 2021
Først indsendt, der opfyldte QC-kriterier
10. december 2021
Først opslået (Faktiske)
29. december 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. november 2026
Sidst verificeret
1. december 2025
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- DMVT-505-3004
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .