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

Phase 2

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: AK120 300mg Q2W (JAK inhibitor users need to double the initial dose)

• Registration Number: NCT06700499
• Lead Sponsor: Akeso

Brief 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.

Detailed Description

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. The total duration of the study (including screening period, treatment period and follow-up period) planned for each subject is approximately 25 weeks.

Study Timeline

• Study Start: 2024-07-08
• Status Verified: 2024-11
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-11-17
• Study Completion: 2025-11-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AK120 300mg Q2W(Double the initial dose)	AK120 300mg Q2W (JAK inhibitor users need to double the initial dose)	AK120 600mg (first day) then 300mg Q2W SC until week 14.

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events (TEAEs)	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

Secondary Outcome Measures

Name	Time	Method
Eczema Area and Severity Index (EASI) score	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	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	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	before drug administration at week 0/4/8/12/16	Assessment of AUC of AK120.
Anti-drug antibodies (ADA) of AK120	before drug administration at week 0/4/8/16/20	Percentage of subjects with detectable anti drug antibodies (ADA) of AK120.

Trial Locations

Locations (50)

Beijing Luhe Hospital Affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Xiyuan Hospital of CACMS; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

The Second Affiliated Hospital of Xiamen Medical College; 🇨🇳 Xiamen, Fujian, China

The Second Hospital & Clinical Medical School, Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

Guangdong Provincial Dermatology Hospital; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Second people's Hospital of Shenzhen; 🇨🇳 Shenzhen, Guangdong, China

Shenzhen Hospital of University of Hong Kong; 🇨🇳 Shenzhen, Guangdong, China

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