NCT06092762CompletedPhase 2
A Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis
a Multicenter, Randomized, Open Label Phase II Clinical Study to Evaluate the Safety and Efficacy of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 25 Nov 2024
Brief summary (registry, in English)
This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (actual)
- First submitted
- 16 Oct 2023
- Start date
- 6 Nov 2023
- Primary completion date
- 13 Nov 2024
- Lead sponsor
- Akeso
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06092762
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 180
- From 6 Nov 2023 to the primary completion date, 13 Nov 2024
- 26 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
- Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
- 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)
- Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
- Received allergen specific immunotherapy within the 3 months before randomization.
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 ≥18≤75 years old.
- Atopic dermatitis (AD) diagnosed at least half a year before screening.
- Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
- Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baoji Central Hospital Coordinator of this site? Confirm its status | Baoji | China | Unknown status |
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Air Force Medical Center Coordinator of this site? Confirm its status | Beijing | 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 |
| Zhujiang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
| Ningbo No.2 Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| QingDao Municipal Hospital Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| The Second Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Second hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Taiyuan Central Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Renmin Hospital of Wuhan University/Hubei General Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The Second Affiliated Hospital of Xiamen Medical College Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| People Hospital of Xingtai Coordinator of this site? Confirm its status | Xingtai | China | Unknown status |
| Yancheng NO.1 People's Hospital Coordinator of this site? Confirm its status | Yancheng | China | Unknown status |
| General Hospital of Ningxia Medical University Coordinator of this site? Confirm its status | Yinchuan | China | Unknown status |
| The Fourth Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Yiwu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.