AK120 Study in Teens With Moderate-to-Severe Atopic Dermatitis
Tests the drug AK120 in teenagers with moderate-to-severe atopic dermatitis, a skin condition.
Plain-language title generated from the registry record
Registry title: A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis (AD)
Key facts
- Where
- Changsha, Dongguan, Guangzhou, Ningbo, and Shenzhen, ChinaSee the 6 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 18 years old?
Source: NCT06756126, who can take part
Where in China
- Hunan Pediatric Medical UnionChangsha, ChinaNo longer taking part
- Xiangya Hospital Central South UniversityChangsha, ChinaNo longer taking part
- Dongguan People's HospitalDongguan, ChinaNo longer taking part
- The second Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaNo longer taking part
- Ning Bo No.2 HospitalNingbo, ChinaNo longer taking part
- The University of Hong Kong-Shenzhen HospitalShenzhen, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Akeso
- Trial code
- NCT06756126
- Record updated
- 1 January 2025
- Original description
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 dermatitisRead full original descriptionShow less
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
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
Inclusion: 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.
Exclusion: 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.