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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: AK120; Drug: AK120; Drug: AK120; Drug: Placebo; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 416
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Guoqin Wang; Phone Number: +86 (0760) 8987 3999; Email: global.trials@akesobio.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • Recruiting
      • AkesoBio Investigative Site 2037, The First Affiliated Hospital of Bengbu Medical College
    • Wuhu, Anhui, China
      • Recruiting
      • AkesoBio Investigative Site 2036, The First Affiliated Hospital of Wannan Medical College
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • AkesoBio Investigative Site 1001, Peking University People's Hospital
    • Beijing, Beijing, China
      • Recruiting
      • AkesoBio Investigative Site 2044, Beijing Friendship Hospital, Capital Medical University
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • AkesoBio Investigative Site 2023, Xinqiao Hospital Medical University
    • Chongqing, Chongqing, China
      • Recruiting
      • AkesoBio Investigative Site 2024, Chongqing Three Gorges Medical College
    • Chongqing, Chongqing, China
      • Recruiting
      • AkesoBio Investigative Site 2040, Chongqing Traditional Chinese Medicine Hospital
    • Chongqing, Chongqing, China
      • Recruiting
      • AkesoBio Investigative Site 2052, The First Affiliated Hospital of Chongqing Medical University
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • AkesoBio Investigative Site 2038, The First Affiliated Hospital of Fujian Medical University
  • Guangdong
    • Dongguan, Guangdong, China
      • Recruiting
      • AkesoBio Investigative Site 2022, Dongguan People's Hospital
    • Guangzhou, Guangdong, China
      • Recruiting
      • AkesoBio Investigative Site 1002, Guangdong Provincial People's Hospital
    • Guangzhou, Guangdong, China
      • Recruiting
      • AkesoBio Investigative Site 2003, Dermatology Hospital of Southern Medical University
  • Guizhou
    • Guiyang, Guizhou, China
      • Recruiting
      • AkesoBio Investigative Site 2049, The Affiliated Hospital of Guizhou Medical University
  • Hainan
    • Haikou, Hainan, China
      • Recruiting
      • AkesoBio Investigative Site 2004, The First Affiliated Hospital of Hainan Medical University
  • Hebei
    • Chengde, Hebei, China
      • Recruiting
      • AkesoBio Investigative Site 2001, Affiliated Hospital of Chengde medical university
  • Henan
    • Nanyang, Henan, China
      • Recruiting
      • AkesoBio Investigative Site 2010, Nanyang First People's Hospital National Third Class A Hospital
  • Hubei
    • Jingzhou, Hubei, China
      • Recruiting
      • AkesoBio Investigative Site 2051, Jingzhou Central Hospital
    • Wuhan, Hubei, China
      • Recruiting
      • AkesoBio Investigative Site 1005, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • AkesoBio Investigative Site 2046, The Third Xiangya Hospital of Central South University
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China
      • Recruiting
      • AkesoBio Investigative Site 2008, The Affiliated Hospital of Inner Mongolia Medical University
  • Jiangsu
    • Changzhou, Jiangsu, China
      • Recruiting
      • AkesoBio Investigative Site 2048, The First People's Hospital of Changzhou
    • Wuxi, Jiangsu, China
      • Recruiting
      • AkesoBio Investigative Site 2050, Wuxi Second People's Hospital
    • Zhenjiang, Jiangsu, China
      • Recruiting
      • AkesoBio Investigative Site 2025, Affiliated Hospital of Jiangsu University
  • Jiangxi
    • Ganzhou, Jiangxi, China
      • Recruiting
      • AkesoBio Investigative Site 2032, The First Affiliated Hospital of Gannan Medical College
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • AkesoBio Investigative Site 2011, Northeast International Hospital
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • AkesoBio Investigative Site 2039, Shandong Provincial Dermatology Hospital
    • Jinan, Shandong, China
      • Recruiting
      • AkesoBio Investigative Site 2041, Qilu Hospital of Shandong University
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • AkesoBio Investigative Site 1003, Shanghai Skin Disease Hospital
  • Shanxi
    • Xianyang, Shanxi, China
      • Recruiting
      • AkesoBio Investigative Site 2027, Medical School of Yanan University
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • AkesoBio Investigative Site 2029, West China Hospital，Sichuan University
    • Chengdu, Sichuan, China
      • Recruiting
      • AkesoBio Investigative Site 2034, Chengdu Second People's Hospital
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • AkesoBio Investigative Site 2013, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
    • Tianjin, Tianjin, China
      • Recruiting
      • AkesoBio Investigative Site 2019, Tianjin Medical University General Hospital
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • AkesoBio Investigative Site 2043, First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • AkesoBio Investigative Site 1004, Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China
      • Recruiting
      • AkesoBio Investigative Site 2006,Affiliated Hangzhou First People's Hospital
    • Hangzhou, Zhejiang, China
      • Recruiting
      • AkesoBio Investigative Site 2007, Hangzhou Third People's Hospital
    • Hangzhou, Zhejiang, China
      • Recruiting
      • AkesoBio Investigative Site 2035, The Second Affiliated Hospital Zhejiang University School of Medicine
    • Jiaxing, Zhejiang, China
      • Recruiting
      • AkesoBio Investigative Site 2009, The First Hospital of Jiaxing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

10

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Phase Ib	T1/2 of AK120. Assessment of half-life(t1/2) of AK120.	Baseline to week 12
Phase Ib	AUC of AK120. Assessment of Area under the curve(AUC) of AK120	Baseline to week 12
Phase Ib	Cmax of AK120. Assessment of Peak concentration(Cmax) of AK120	Baseline to week 12
Phase Ib	Tmax of AK120. Assessment of Time to peak(Tmax) of AK120	Baseline to week 12
Phase II	Percentage of subjects who achieved (Eczema Area and Severity Index)EASI-75	at week 16
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase Ib	Percentage of subjects with detectable anti AK120 antibodies (ADA).	Baseline to week 12
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Akeso

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: AK120-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No