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AkesoA Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis (AD) Phase II 24 Adolescent Ouvert
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT06756126 est conçu pour étudier le traitement de Dermatite atopique. Il s'agit d'une étude interventionnel en Phase II. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 30 décembre 2024, avec un objectif de 24 participants. Dirigée par Akeso, l'étude devrait être terminée d'ici le 30 juin 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 1 janvier 2025.
Résumé succinct
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
Description détaillée
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.
Titre officiel
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
Pathologies
Dermatite atopiqueAutres identifiants de l'étude
- AK120-208
Numéro NCT
Date de début (réel)
2024-12-30
Dernière mise à jour publiée
2025-01-01
Date de fin (estimée)
2025-06-30
Inscription (estimée)
24
Type d'étude
Interventionnel
PHASE
Phase II
Statut
Pas encore en recrutement
Objectif principal
Traitement
Méthode d'allocation
Non randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalAK120 300mg every two weeks (Q2W) subcutaneous injection Subjects with heavy weight | AK120 AK120 subcutaneous injection |
ExpérimentalAK120 300mg every three weeks (Q3W) subcutaneous injection Subjects with light weight | AK120 AK120 subcutaneous injection |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Enfant, Adulte
Âge minimum
12 Years
Sexes éligibles
Tous
- 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.
AkesoContact central de l'étude
Contact: Guoqin Wang, 86 (0760) 8987 3999, [email protected]
6 Centres de l'étude dans 1 pays
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