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AkesoA Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis (AD) Fase 2 24 Adolescenten Open-label
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De klinische studie NCT06756126 onderzoekt behandeling bij Atopische dermatitis. Deze Fase 2 interventioneel studie heeft de status nog niet rekruterend. De inclusie van 24 deelnemers begint op 30 december 2024. De studie wordt geleid door Akeso en de voltooiing is gepland op 30 juni 2025. Laatste update op ClinicalTrials.gov: 1 januari 2025.
Beknopte samenvatting
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
Uitgebreide beschrijving
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.
Officiële 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
Aandoeningen
Atopische dermatitisAndere studie-ID's
- AK120-208
NCT-ID
Startdatum (Werkelijk)
2024-12-30
Laatste update geplaatst
2025-01-01
Verwachte einddatum
2025-06-30
Inschrijving (Geschat)
24
Studietype
Interventioneel
FASE
Fase 2
Status
Nog niet rekruterend
Primaire doel
Behandeling
Toewijzing
Niet-gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelAK120 300mg every two weeks (Q2W) subcutaneous injection Subjects with heavy weight | AK120 AK120 subcutaneous injection |
ExperimenteelAK120 300mg every three weeks (Q3W) subcutaneous injection Subjects with light weight | AK120 AK120 subcutaneous injection |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Kind, Volwassene
Minimumleeftijd
12 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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.
AkesoCentraal Contactpersoon
Contact: Guoqin Wang, 86 (0760) 8987 3999, [email protected]
6 Studielocaties in 1 landen
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