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

• Sponsor: Akeso (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06092762
• Collaborator: (none)
• Enrollment: 180
• Locations: 26
• Arms: 2
• Anticipated Duration (Months): 18.7
• Patients Per Site: 6.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: AK120	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Nov 6, 2023
• Anticipated Primary Completion Date: Oct 19, 2024
• Anticipated Study Completion Date: May 29, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AK120 300mg AK120 loading dose 600mg, then 300mg subcutaneous injection every 2 weeks thereafter until week 14.	Drug: AK120; subcutaneous injection every 2 weeks
Experimental: AK120 450mg AK120 loading dose 600mg, then 450mg subcutaneous injection every 2 weeks thereafter until week 14.	Drug: AK120; subcutaneous injection every 2 weeks

Outcome Measures

Primary Outcome Measures

1. Incidence of adverse events(AE) [week 0 to week 24]

   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

Secondary Outcome Measures

1. Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75 [at week 2/4/8/12/16 /20 and 24]

2. Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-50 [at week 2/4/8/12/16 /20 and 24]

3. Percentage change in (Eczema Area and Severity Index) EASI scores from baseline [at week 2/4/8/12/16 /20 and 24]

4. Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA [at week 2/4/8/12/16 /20 and 24]

5. 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]

6. Percentage change in (affected body surface area) BSA score from baseline [at week 2/4/8/12/16 /20 and 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui	China
2	Air Force Medical Center	Beijing	Beijing	China
3	China-Japan Friendship Hospital	Beijing	Beijing	China
4	Peking University Third Hospital	Beijing	Beijing	China
5	The Second Affiliated Hospital of Xiamen Medical College	Xiamen	Fujian	China
6	Dongguan People's Hospital	Dongguan	Guangdong	China
7	Dermatology Hospital of Southern Medical University	Guangzhou	Guangdong	China
8	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China
9	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong	China
10	Shenzhen People's Hospital	Shenzhen	Guangdong	China
11	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei	China
12	People Hospital of Xingtai	Xingtai	Hebei	China
13	Renmin Hospital of Wuhan University Hubei General Hospital	Wuhan	Hubei	China
14	Affiliated Hospital of Nantong University	Nantong	Jiangsu	China
15	Yancheng No.1 People's Hospital	Yancheng	Jiangsu	China
16	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China
17	General Hospital of Ningxia Medical University	Yinchuan	Ningxia	China
18	Qingdao Municipal Hospital	Qingdao	Shandong	China
19	Baoji Central Hospital	Baoji	Shanxi	China
20	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi	China
21	Taiyuan Central Hospital	Taiyuan	Shanxi	China
22	Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital	Tianjin	Tianjin	China
23	The First Affiliated Hospital，Zhejiang University School of Medicine	Hangzhou	Zhejiang	China
24	Ningbo No.2 Hospital	Ningbo	Zhejiang	China
25	The first affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang	China
26	The Fourth Affiliated Hospital of Zhejiang University School of Medicine	Yiwu	Zhejiang	China

Sponsors and Collaborators

• Akeso

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Akeso
• ClinicalTrials.gov Identifier: NCT06092762
• Other Study ID Numbers: AK120-206
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema

Study Results

No Results Posted as of Oct 23, 2023