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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035354
• Other study ID #: AK120-102
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 3, 2021
• Est. completion date: October 30, 2024

Study information

• Verified date: September 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 416
• Est. completion date: October 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• AK120
subcutaneous injection once a week
• AK120
subcutaneous injection once a week
• Placebo
subcutaneous injection once a week.
• AK120
subcutaneous injection every 2 weeks.
• AK120
subcutaneous injection every 2 weeks.
• AK120
subcutaneous injection every 2 weeks.
• Placebo
subcutaneous injection every 2 weeks for 16 weeks then crossover to AK120 Regimen 4 and Regimen 5.
• AK120
subcutaneous injection every 2 weeks
• AK120
subcutaneous injection every 2 weeks.
• AK120
subcutaneous injection every 2 weeks.

Locations

Country	Name	City	State
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 2037, The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	AkesoBio Investigative Site 2046, The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	AkesoBio Investigative Site 2048, The First People's Hospital of Changzhou	Changzhou	Jiangsu
China	AkesoBio Investigative Site 2001, Affiliated Hospital of Chengde medical university	Chengde	Hebei
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 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 2022, Dongguan People's Hospital	Dongguan	Guangdong
China	AkesoBio Investigative Site 2038, The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	AkesoBio Investigative Site 2032, The First Affiliated Hospital of Gannan Medical College	Ganzhou	Jiangxi
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 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 2008, The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	AkesoBio Investigative Site 2009, The First Hospital of Jiaxing	Jiaxing	Zhejiang
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 2051, Jingzhou Central Hospital	Jingzhou	Hubei
China	AkesoBio Investigative Site 2043, First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	AkesoBio Investigative Site 2010, Nanyang First People's Hospital National Third Class A Hospital	Nanyang	Henan
China	AkesoBio Investigative Site 1003, Shanghai Skin Disease Hospital	Shanghai	Shanghai
China	AkesoBio Investigative Site 2011, Northeast International Hospital	Shenyang	Liaoning
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 1005, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	AkesoBio Investigative Site 2036, The First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui
China	AkesoBio Investigative Site 2050, Wuxi Second People's Hospital	Wuxi	Jiangsu
China	AkesoBio Investigative Site 2027, Medical School of Yanan University	Xianyang	Shanxi
China	AkesoBio Investigative Site 2025, Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase Ib	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.	Baseline to week 12
Primary	Phase Ib	T1/2 of AK120. Assessment of half-life(t1/2) of AK120.	Baseline to week 12
Primary	Phase Ib	AUC of AK120. Assessment of Area under the curve(AUC) of AK120	Baseline to week 12
Primary	Phase Ib	Cmax of AK120. Assessment of Peak concentration(Cmax) of AK120	Baseline to week 12
Primary	Phase Ib	Tmax of AK120. Assessment of Time to peak(Tmax) of AK120	Baseline to week 12
Primary	Phase II	Percentage of subjects who achieved (Eczema Area and Severity Index)EASI-75	at week 16
Primary	Phase II Extension Study	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.	Baseline to week 24
Secondary	Phase Ib	Percentage of subjects with detectable anti AK120 antibodies (ADA).	Baseline to week 12
Secondary	Phase Ib	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	Baseline to week 12
Secondary	Phase II	Percentage of subjects who achieved EASI-50 (=50% improvement from baseline) /EASI-75 (=75% improvement from baseline) response at each visit.; Higher score mean better outcome, lower score mean worse outcome	Baseline to week 58
Secondary	Phase II	Percentage change in EASI scores from baseline at each visit. Higher score mean better outcome, lower score mean worse outcome	Baseline to week 58
Secondary	Phase II Extension Study	Percentage of subjects who achieved EASI-50 (=50% improvement from baseline) /EASI-75 (=75% improvement from baseline) response at each visit.; Higher score mean better outcome, lower score mean worse outcome	Baseline to week 24
Secondary	Phase II Extension Study	Percentage change in EASI scores from baseline at each visit. Higher score mean better outcome, lower score mean worse outcome	Baseline to week 24