NCT06767540Not yet recruitingPhase 3
A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis
A Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of AK120 in the Treatment of Moderate-to-severe Atopic Dermatitis (AD) in Adolescents
Source: ClinicalTrials.gov · Last updated 10 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 in the treatment of moderate-to-severe AD in adolescents.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 198 (estimated)
- First submitted
- 8 Jan 2025
- Start date
- 23 Jan 2025
- Primary completion date
- 10 Jul 2027
- Lead sponsor
- Akeso
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06767540
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 198
- From 23 Jan 2025 to the primary completion date, 10 Jul 2027
- 28 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 4 weeks or 5 halflives before randomization (whichever is longer).
Other illness
- Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.
Who the study is looking for
- Male or female subjects aged ≥12\<18 years old, weight ≥ 30kg.
- AD diagnosed at least half a year before screening.
- Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline
- Daily peak P-NRS scores (weekly average) at baseline visit ≥ 4.
Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Hunan Children's Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| XiangYa Hospital CentralSouth University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Chongqing Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Dongguan People's Hospital Coordinator of this site? Confirm its status | Dongguan | China | Unknown status |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Dermatology Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital of Jinan University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Jiangmen Central Hospital Coordinator of this site? Confirm its status | Jiangmen | China | Unknown status |
| The First Hospital Of Jiaxing Coordinator of this site? Confirm its status | Jiaxing | China | Unknown status |
| Shandong Provincial Dermatology Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jining First People's Hospital Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| Jinzhou Central Hospital Coordinator of this site? Confirm its status | Jinzhou | China | Unknown status |
| The First Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Liuzhou Worker's Hospital Coordinator of this site? Confirm its status | Liuzhou | China | Unknown status |
| Dermatology Hospital of Jiangxi Province Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Shanghai Skin Disease Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| LongHua Hospital Shanghai University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The University of Hong Kong-Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| the Second Affiliated Hospital of Wannan Medical College Coordinator of this site? Confirm its status | Wuhu | China | Unknown status |
| The First Affiliated Hospital of Xi'an Jiao Tong University Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
| The Third People's Hospital of Zhuhai Coordinator of this site? Confirm its status | Zhuhai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.