A Phase II Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06092762
• Other study ID #: AK120-206
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 6, 2023
• Est. completion date: May 29, 2025

Study information

• Verified date: October 2023
• Source: Akeso
• Contact: Guoqin Wang
• Phone: +86 (0760) 8987 3999
• Email: global.trials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. The total duration of the study (including screening period) planned for each subject is approximately 29 weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: May 29, 2025
• Est. primary completion date: October 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months

Exclusion Criteria:

1. Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.

2. Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization

3. Received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer)

4. Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.

5. Received allergen specific immunotherapy within the 3 months before randomization.

6. Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• AK120
subcutaneous injection every 2 weeks

Locations

Country	Name	City	State
China	Baoji Central Hospital	Baoji	Shanxi
China	Air Force Medical Center	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Dongguan People's Hospital	Dongguan	Guangdong
China	Dermatology Hospital of Southern Medical University	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital,Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Ningbo No.2 Hospital	Ningbo	Zhejiang
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Taiyuan Central Hospital	Taiyuan	Shanxi
China	Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital	Tianjin	Tianjin
China	The first affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Renmin Hospital of Wuhan University Hubei General Hospital	Wuhan	Hubei
China	The Second Affiliated Hospital of Xiamen Medical College	Xiamen	Fujian
China	People Hospital of Xingtai	Xingtai	Hebei
China	Yancheng No.1 People's Hospital	Yancheng	Jiangsu
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	The Fourth Affiliated Hospital of Zhejiang University School of Medicine	Yiwu	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events(AE)	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	week 0 to week 24
Secondary	Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75		at week 2/4/8/12/16 /20 and 24
Secondary	Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-50		at week 2/4/8/12/16 /20 and 24
Secondary	Percentage change in (Eczema Area and Severity Index) EASI scores from baseline		at week 2/4/8/12/16 /20 and 24
Secondary	Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA		at week 2/4/8/12/16 /20 and 24
Secondary	Percentage of subjects with a (Investigator's Global Assessment) IGA score decrease of = 2 points from baseline		at week 2/4/8/12/16 /20 and 24
Secondary	Percentage change in (affected body surface area) BSA score from baseline		at week 2/4/8/12/16 /20 and 24