Evaluating AK120 for treating moderate to severe atopic dermatitis
A Multicenter, Open Label Phase II Clinical Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis
This study is testing a new treatment called AK120 to see if it can help people with moderate to severe atopic dermatitis feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Akeso Industry-sponsored |
| Locations | 50 sites (Beijing, Beijing and 49 other locations) |
| Trial ID | NCT06700499 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label phase II clinical study aims to assess the efficacy and safety of AK120 in patients suffering from moderate to severe atopic dermatitis. Participants will receive AK120 at a dosage of 300mg every two weeks, with adjustments for those using JAK inhibitors. The study will span approximately 25 weeks, including screening, treatment, and follow-up periods. The primary focus is on patients with significant disease severity, as indicated by specific scoring criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of moderate to severe atopic dermatitis.
Not a fit: Patients with acute onset of atopic dermatitis or those with a history of certain malignancies or immunosuppressive diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief and improved quality of life for patients with moderate to severe atopic dermatitis.
How similar studies have performed: Other studies evaluating similar JAK inhibitors have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female subjects aged ≥18≤75 years old. 2. Atopic dermatitis (AD) diagnosed at least half a year before screening. 3. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline. 4. Subjects who are suitable for continue using biological treatment assessed by investigator Exclusion Criteria: 1. Acute onset of AD within 4 weeks before drug administration. 2. The accompany disease have been assessed by the investigators during screening period as unsuitable for participation in this study. 3. Any history or symptoms of malignant tumors in any organ within 5 years prior to screening, regardless of whether treatment has been received and whether there are signs of recurrence or metastasis 4. Have a known or suspected history of immunosuppressive diseases, including a history of invasive infections. 5. Having undergone or planned major surgery within 4 weeks prior to drug administration, or unable to fully recover from surgery prior to drug administration. 6. any medical or psychological condition that puts subjects at risk or may affect the study results assessed by investigators.
Where this trial is running
Beijing, Beijing and 49 other locations
- Beijing Luhe Hospital Affiliated to Capital Medical University — Beijing, Beijing, China (Recruiting)
- Peking University Third Hospital — Beijing, Beijing, China (Recruiting)
- Xiyuan Hospital of CACMS — Beijing, Beijing, China (Recruiting)
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
- The Second Affiliated Hospital of Xiamen Medical College — Xiamen, Fujian, China (Not_yet_recruiting)
- The Second Hospital & Clinical Medical School, Lanzhou University — Lanzhou, Gansu, China (Recruiting)
- Guangdong Provincial Dermatology Hospital — Guangzhou, Guangdong, China (Recruiting)
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
- Second people's Hospital of Shenzhen — Shenzhen, Guangdong, China (Recruiting)
- Shenzhen Hospital of University of Hong Kong — Shenzhen, Guangdong, China (Recruiting)
- Liuzhou People's Hospital — Liuzhou, Guangxi, China (Recruiting)
- Cangzhou People's Hospital — Cangzhou, Hebei, China (Recruiting)
- Affiliated Hospital of Chengde Medical University — Chengde, Hebei, China (Recruiting)
- Shijiazhuang Hospital of Traditional Chinese Medicine — Shijiazhuang, Hebei, China (Recruiting)
- The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
- People Hospital of Xingtai — Xingtai, Hebei, China (Recruiting)
- The Second Affiliated Hospital of Xingtai Medical College — Xingtai, Hebei, China (Recruiting)
- Anyang District Hospital — Anyang, Henan, China (Recruiting)
- The Second Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (Recruiting)
- Sanmenxia Central Hospital — Sanmenxia, Henan, China (Recruiting)
- Jingzhou Central Hospital — Jingzhou, Hubei, China (Recruiting)
- Renmin Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
- Wuhan No.1 Hospital — Wuhan, Hubei, China (Recruiting)
- Changde First People's Hospital — Changde, Hunan, China (Recruiting)
- XiangYa Hospital CentralSouth University — Changsha, Hunan, China (Recruiting)
- Yueyang Central Hospital — Yueyang, Hunan, China (Recruiting)
- The Affiliated Hospital of Inner Mongolia Medical College — Hohhot, Inner Mongolia, China (Recruiting)
- Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
- Wuxi People's Hospital — Wuxi, Jiangsu, China (Recruiting)
- Affiliated Hospital of Jiangsu University — Zhenjiang, Jiangsu, China (Recruiting)
- The Affiliated Hospital of Yanbian University Yanbian Hospital — Yanbian, Jilin, China (Recruiting)
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
- Shandong First Medical University Affiliated Dermatology Hospital — Jinan, Shandong, China (Recruiting)
- Yantai Yuhuangding Hospital — Yantai, Shandong, China (Recruiting)
- Shanghai Skin Disease Hospital — Shanghai, Shanghai, China (Recruiting)
- Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital — Shanghai, Shanghai, China (Recruiting)
- Taiyuan Central Hospital — Taiyuan, Shanxi, China (Recruiting)
- Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
- The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine — Tianjin, Tianjin, China (Recruiting)
- Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital — Tianjin, Tianjin, China (Recruiting)
- Xinjiang Uygur Municipal People's Hospital — Urumqi, Xinjiang, China (Recruiting)
- The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Recruiting)
- Qujing No.1 Hospital — Qujing, Yunnan, China (Recruiting)
- Affiliated Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
- Hangzhou Third People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
- The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
- Jiaxing Second Hospital — Jiaxing, Zhejiang, China (Recruiting)
- The First Hospital of Jiaxing — Jiaxing, Zhejiang, China (Recruiting)
- Ningbo No.2 Hospital — Ningbo, Zhejiang, China (Recruiting)
- Taizhou Central Hospital — Taizhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Guoqin Wang
- Email: global.trials@akesobio.com
- Phone: +86 (0760) 8987 3999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.