A Study to Evaluate the Efficacy and Safety of AK120 in Subjects With Moderate to Severe Atopic Dermatitis
- Summary
- This is 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.
- Short title
- A Study to Evaluate the Efficacy and Safety of AK120 in Subjects With Moderate to Severe Atopic Dermatitis
- Official title
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2025-09-11
- First posted
- 2024-11-22
- Registry last updated
- 2026-03-17
- Primary completion date
- 2025-07-31
- Start date
- 2024-07-08
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Akeso
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06700499
- ClinicalTrials.gov ID
- NCT06700499
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
Incidence of treatment emergent adverse events (TEAEs)
Timeframe: through study completion, an average of 25 weeks
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
Eczema Area and Severity Index (EASI) score
Timeframe: baseline to week 20
Percentage change in EASI score from baseline. EASI score is to assesses the extent and severity of eczema in four body regions with the score ranges from 0 to 72. The higher the score, the more severe the eczema.
Investigator's Global Assessment (IGA) 0/1
Timeframe: from baseline to week 20
Percentage of subjects who achieved 0/1 in the IGA. The IGA is an assessment instrument used in clinical studies to rate the severity of atopic dermatitis globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Affected body surface area (BSA) score
Timeframe: from baseline to week 20
Percentage change in BSA score from baseline. Body surface area affected by atopic dermatitis will be assessed for each section of the body (0-100%) and will be reported as a percentage of all major body sections combined.
Area under the curve(AUC) of AK120
Timeframe: before drug administration at week 0/4/8/12/16
Assessment of AUC of AK120.
Anti-drug antibodies (ADA) of AK120
Timeframe: before drug administration at week 0/4/8/16/20
Percentage of subjects with detectable anti drug antibodies (ADA) of AK120.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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 who are suitable for continue using biological treatment assessed by investigator
- Acute onset of AD within 4 weeks before drug administration.
- The accompany disease have been assessed by the investigators during screening period as unsuitable for participation in this study.
- 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
- Have a known or suspected history of immunosuppressive diseases, including a history of invasive infections.
- Having undergone or planned major surgery within 4 weeks prior to drug administration, or unable to fully recover from surgery prior to drug administration.
- any medical or psychological condition that puts subjects at risk or may affect the study results assessed by investigators.
- Beijing Luhe Hospital Affiliated to Capital Medical UniversityBeijing, China
- Peking University Third HospitalBeijing, China
- Xiyuan Hospital of CACMSBeijing, China
- The First Affiliated Hospital of Fujian Medical UniversityFuzhou, China
- The Second Affiliated Hospital of Xiamen Medical CollegeXiamen, China
- The Second Hospital & Clinical Medical School, Lanzhou UniversityLanzhou, China
- Guangdong Provincial Dermatology HospitalGuangzhou, China
- Guangdong Provincial People's HospitalGuangzhou, China
- Second people's Hospital of ShenzhenShenzhen, China
- Shenzhen Hospital of University of Hong KongShenzhen, China
- Liuzhou People's HospitalLiuzhou, China
- Cangzhou People's HospitalCangzhou, China
- Affiliated Hospital of Chengde Medical UniversityChengde, China
- Shijiazhuang Hospital of Traditional Chinese MedicineShijiazhuang, China
- The First Hospital of Hebei Medical UniversityShijiazhuang, China
- People Hospital of XingtaiXingtai, China
- The Second Affiliated Hospital of Xingtai Medical CollegeXingtai, China
- Anyang District HospitalAnyang, China
- The Second Affiliated Hospital of Henan University of Science and TechnologyLuoyang, China
- Sanmenxia Central HospitalSanmenxia, China
- Jingzhou Central HospitalJingzhou, China
- Renmin Hospital of Wuhan UniversityWuhan, China
- Wuhan No.1 HospitalWuhan, China
- Changde First People's HospitalChangde, China
- XiangYa Hospital CentralSouth UniversityChangsha, China
And 25 more, listed on the interactive page.
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Atopic eczema Primary condition