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AkesoA Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis (AD) Phase 2 24 Adolescent Open-Label
Clinical Trial NCT06756126 is designed to study Treatment for Atopic Dermatitis. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on December 30, 2024 until the study accrues 24 participants. Led by Akeso, this study is expected to complete by June 30, 2025. The latest data from ClinicalTrials.gov was last updated on January 1, 2025.
Brief Summary
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
Detailed Description
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.
Official Title
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
Conditions
Atopic DermatitisOther Study IDs
- AK120-208
NCT ID Number
Start Date (Actual)
2024-12-30
Last Update Posted
2025-01-01
Completion Date (Estimated)
2025-06-30
Enrollment (Estimated)
24
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalAK120 300mg every two weeks (Q2W) subcutaneous injection Subjects with heavy weight | AK120 AK120 subcutaneous injection |
ExperimentalAK120 300mg every three weeks (Q3W) subcutaneous injection Subjects with light weight | AK120 AK120 subcutaneous injection |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
12 Years
Eligible Sexes
All
- 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.
AkesoStudy Central Contact
Contact: Guoqin Wang, 86 (0760) 8987 3999, [email protected]
6 Study Locations in 1 Countries
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