A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in Subjects With Atopic Dermatitis

Phase 1

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: AK120; Drug: Placebo

• Registration Number: NCT06035354
• Lead Sponsor: Akeso

Brief Summary

This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical study to evaluate the safety, pharmacokinetics and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.

Detailed Description

This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical study to evaluate the safety, pharmacokinetics and efficacy of AK120 in subjects with moderate to severe atopic dermatitis.

Study Timeline

• Study Start: 2021-11-03
• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-13
• Primary Completion: 2024-06-21
• Study Completion: 2024-06-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-02
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 427

Inclusion Criteria

1. Male or female with age 18 - 75 years (inclusive).
2. Atopic dermatitis (AD) diagnosed at least half an 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. Suffering from other inflammatory diseases that may affect efficacy outcomes (such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.).
2. History of exposure to active TB, and/or history or current evidence of TB infection.
3. Positive serology results at Screening for hepatitis B, hepatitis C or HIV.
4. Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit.
5. History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit
6. Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with participation in the study, or interfere with the interpretation of study results.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK120 150mg in phase II	AK120	subcutaneous injection every 2 weeks for 50 weeks.
AK120 300mg in phase II	AK120	subcutaneous injection every 2 weeks for 50 weeks.
AK120 450mg in phase II	AK120	subcutaneous injection every 2 weeks for 50 weeks.
Placebo Comparator: Placebo in phase II	Placebo	subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 4 and Regimen 5, subcutaneous injection at week 16, after primary endpoint evaluation.
AK120 150 mg in phase Ib	AK120	subcutaneous injection once a week for 4 weeks.
AK120 300mg in phase Ib	AK120	subcutaneous injection once a week for 4 weeks.
Placebo Comparator: Placebo in phase Ib	Placebo	subcutaneous injection once a week for 4 weeks.
AK120 150mg in phase II extension	AK120	subcutaneous injection every 2 weeks for 14 weeks.
AK120 300mg in phase II extension	AK120	subcutaneous injection every 2 weeks for 14 weeks.
AK120 450mg in phase II extension	AK120	subcutaneous injection every 2 weeks for 14 weeks.

Primary Outcome Measures

Name	Time	Method
Phase Ib	Baseline to week 12	Tmax of AK120. Assessment of Time to peak(Tmax) of AK120
Phase II	at week 16	Percentage of subjects who achieved (Eczema Area and Severity Index)EASI-75
Phase II Extension Study	Baseline to week 24	Incidence of treatment emergent 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.

Secondary Outcome Measures

Name	Time	Method
Phase II Extension Study	Baseline to week 24	Percentage change in EASI scores from baseline at each visit. Higher score mean better outcome, lower score mean worse outcome
Phase Ib	Baseline to week 12	Percentage of subjects who achieved 0/1 in the Investigator's Global Assessment (IGA)(on a 6-point scale) .; Lower score of IGA mean better outcome, higher score mean worse outcome
Phase II	Baseline to week 58	Percentage change in EASI scores from baseline at each visit. Higher score mean better outcome, lower score mean worse outcome

Trial Locations

Locations (39)

AkesoBio Investigative Site 2037, The First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, Anhui, China

AkesoBio Investigative Site 2036, The First Affiliated Hospital of Wannan Medical College; 🇨🇳 Wuhu, Anhui, China

AkesoBio Investigative Site 1001, Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

AkesoBio Investigative Site 2044, Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

AkesoBio Investigative Site 2023, Xinqiao Hospital Medical University; 🇨🇳 Chongqing, Chongqing, China

AkesoBio Investigative Site 2024, Chongqing Three Gorges Medical College; 🇨🇳 Chongqing, Chongqing, China

AkesoBio Investigative Site 2040, Chongqing Traditional Chinese Medicine Hospital; 🇨🇳 Chongqing, Chongqing, China

AkesoBio Investigative Site 2052, The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

AkesoBio Investigative Site 2038, The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

AkesoBio Investigative Site 2022, Dongguan People's Hospital; 🇨🇳 Dongguan, Guangdong, China

AkesoBio Investigative Site 1002, Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

AkesoBio Investigative Site 2003, Dermatology Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

AkesoBio Investigative Site 2049, The Affiliated Hospital of Guizhou Medical University; 🇨🇳 Guiyang, Guizhou, China

AkesoBio Investigative Site 2004, The First Affiliated Hospital of Hainan Medical University; 🇨🇳 Haikou, Hainan, China

AkesoBio Investigative Site 2001, Affiliated Hospital of Chengde medical university; 🇨🇳 Chengde, Hebei, China

AkesoBio Investigative Site 2010, Nanyang First People's Hospital National Third Class A Hospital; 🇨🇳 Nanyang, Henan, China

AkesoBio Investigative Site 2051, Jingzhou Central Hospital; 🇨🇳 Jingzhou, Hubei, China

AkesoBio Investigative Site 1005, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

AkesoBio Investigative Site 2046, The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

AkesoBio Investigative Site 2008, The Affiliated Hospital of Inner Mongolia Medical University; 🇨🇳 Hohhot, Inner Mongolia, China

AkesoBio Investigative Site 2048, The First People's Hospital of Changzhou; 🇨🇳 Changzhou, Jiangsu, China

AkesoBio Investigative Site 2050, Wuxi Second People's Hospital; 🇨🇳 Wuxi, Jiangsu, China

AkesoBio Investigative Site 2025, Affiliated Hospital of Jiangsu University; 🇨🇳 Zhenjiang, Jiangsu, China

AkesoBio Investigative Site 2032, The First Affiliated Hospital of Gannan Medical College; 🇨🇳 Ganzhou, Jiangxi, China

AkesoBio Investigative Site 2011, Northeast International Hospital; 🇨🇳 Shenyang, Liaoning, China

AkesoBio Investigative Site 2039, Shandong Provincial Dermatology Hospital; 🇨🇳 Jinan, Shandong, China

AkesoBio Investigative Site 2041, Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

AkesoBio Investigative Site 1003, Shanghai Skin Disease Hospital; 🇨🇳 Shanghai, Shanghai, China

AkesoBio Investigative Site 2027, Medical School of Yanan University; 🇨🇳 Xianyang, Shanxi, China

AkesoBio Investigative Site 2029, West China Hospital，Sichuan University; 🇨🇳 Chengdu, Sichuan, China

AkesoBio Investigative Site 2034, Chengdu Second People's Hospital; 🇨🇳 Chengdu, Sichuan, China

AkesoBio Investigative Site 2013, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital; 🇨🇳 Tianjin, Tianjin, China

AkesoBio Investigative Site 2019, Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China

AkesoBio Investigative Site 2043, First Affiliated Hospital of Kunming Medical University; 🇨🇳 Kunming, Yunnan, China

AkesoBio Investigative Site 1004, Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China

AkesoBio Investigative Site 2006,Affiliated Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China

AkesoBio Investigative Site 2007, Hangzhou Third People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China

AkesoBio Investigative Site 2035, The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

AkesoBio Investigative Site 2009, The First Hospital of Jiaxing; 🇨🇳 Jiaxing, Zhejiang, China