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Die klinische Studie NCT06756126 für Atopische Dermatitis ist noch nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
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AkesoA Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis (AD) Phase 2 24 Jugendliche Offene Studie
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06756126 untersucht Behandlung im Zusammenhang mit Atopische Dermatitis. Diese interventionsstudie der Phase 2 hat den Status noch nicht rekrutierend. Der Start ist für 30. Dezember 2024 geplant, bis 24 Teilnehmer aufgenommen werden. Durchgeführt von Akeso wird der Abschluss für 30. Juni 2025 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 1. Januar 2025 aktualisiert.
Kurzbeschreibung
This is a A multicenter, open label, phase II clinical study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics(PD), and preliminary efficacy of AK120 in adolescents with moderate-to-severe atopic dermatitis
Ausführliche Beschreibung
This is a A multicenter, open label, phase II clinical study aimed to evaluate the safety, PK, PD, and preliminary efficacy of AK120 in adolescents with moderate-to-severe AD. The entire study include screening period(week -4 to week 0), treatment and follow-up period(16 weeks). The duration of the study is about 20 weeks.
Offizieller Titel
A Multicenter, Open Label Phase II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AK120 in Adolescents With Moderate-to-severe AD
Erkrankungen
Atopische DermatitisWeitere Studien-IDs
- AK120-208
NCT-Nummer
Studienbeginn (tatsächlich)
2024-12-30
Zuletzt aktualisiert
2025-01-01
Studienende (vorauss.)
2025-06-30
Geplante Rekrutierung
24
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Noch nicht rekrutierend
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellAK120 300mg every two weeks (Q2W) subcutaneous injection Subjects with heavy weight | AK120 AK120 subcutaneous injection |
ExperimentellAK120 300mg every three weeks (Q3W) subcutaneous injection Subjects with light weight | AK120 AK120 subcutaneous injection |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Incidence of adverse events(AE) | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. | week -4 to week 16 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
PK evaluation: maximum plasma concentration (Cmax) | Assessment of Cmax after AK120 administration. | Baseline till last follow-up visit ( up to day 113) |
PK evaluation: time to maximum plasma concentration (Tmax) | Assessment of Tmax after AK120 administration. | Baseline till last follow-up visit ( up to day 113) |
PD evaluation: Thymus and activation regulated chemokine (TARC)/CCL17 | Percentage change in TARC/CCL17 compared to baseline. | Baseline till last follow-up visit ( up to day 113) |
Change in Eczema Area and Severity Index (EASI) scores | Percentage change in EASI scores from baseline. | week 0/2/4/8/12/16 |
Change in affected Body Surface Area (BSA) scores | Percentage change in BSA score from baseline. | week 0/2/4/8/12/16 |
Subjects who achieved 0/1 in the Investigator's Global Assessment (IGA) | Percentage of subjects who achieved IGA 0/1. | week 0/2/4/8/12/16 |
Change in Children's Dermatology Life Quality Index (CDLQI) scores | Percentage change in CDLQI score from baseline. | week 0/2/4/8/12/16 |
Change in Patient Oriented Eczema Measure (POEM) scores | Percentage change in POEM score from baseline. | week 0/2/4/8/12/16 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene
Mindestalter
12 Years
Zugelassene Geschlechter
Alle
- Male or female subjects aged ≥12 <18 years old.
- Weight≥30kg at baseline.
- AD diagnosed at least half a year before screening.
- Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
- Acute onset of AD in 4 weeks prior to enrollment.
- Undergone or planned surgery during the study period within the 4 weeks prior to enrollment, or unable to fully recover from surgery before enrollment.
- Previously suffered from vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC).
- Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization.
- Received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer).
- Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.
AkesoZentrale Studienkontakte
Kontakt: Guoqin Wang, 86 (0760) 8987 3999, [email protected]
6 Studienstandorte in 1 Ländern
Guangdong
Dongguan People's Hospital, Dongguan, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
The University of Hong Kong - Shenzhen Hospital, Shenzhen, Guangdong, China
Hunan
Hunan Pediatric Medical Union, Changsha, Hunan, China
Xiangya Hospital Central South University, Changsha, Hunan, China
Zhejiang
Ning Bo No.2 Hospital, Ningbo, Zhejiang, China