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

NCT06035354 | Completed Phase 1

• 1 other identifier: AK120-102
• Study Type: interventional
• Target: 427
• Locations: 1 country
• Sites: 39

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• Phase Ib

  Baseline to week 12

• Phase Ib

  Baseline to week 12

• Phase II

  Baseline to week 58

• Phase II

  Baseline to week 58

• Phase II Extension Study

  Baseline to week 24

Study Arms (10)

AK120 150 mg in phase Ib

EXPERIMENTAL

subcutaneous injection once a week for 4 weeks.

Drug: AK120

AK120 300mg in phase Ib

EXPERIMENTAL

subcutaneous injection once a week for 4 weeks.

Drug: AK120

Placebo Comparator: Placebo in phase Ib

PLACEBO COMPARATOR

subcutaneous injection once a week for 4 weeks.

Drug: Placebo

AK120 150mg in phase II

EXPERIMENTAL

subcutaneous injection every 2 weeks for 50 weeks.

Drug: AK120

AK120 300mg in phase II

EXPERIMENTAL

subcutaneous injection every 2 weeks for 50 weeks.

Drug: AK120

AK120 450mg in phase II

EXPERIMENTAL

subcutaneous injection every 2 weeks for 50 weeks.

Drug: AK120

Placebo Comparator: Placebo in phase II

PLACEBO COMPARATOR

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

AK120 150mg in phase II extension

EXPERIMENTAL

subcutaneous injection every 2 weeks for 14 weeks.

Drug: AK120

AK120 300mg in phase II extension

EXPERIMENTAL

subcutaneous injection every 2 weeks for 14 weeks.

Drug: AK120

AK120 450mg in phase II extension

EXPERIMENTAL

subcutaneous injection every 2 weeks for 14 weeks.

Drug: AK120

Interventions

AK120 DRUG

subcutaneous injection once a week

AK120 150 mg in phase Ib

Placebo DRUG

subcutaneous injection once a week.

Placebo Comparator: Placebo in phase Ib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female with age 18 - 75 years (inclusive).
• Atopic dermatitis (AD) diagnosed at least half an year before screening.
• Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
• Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months.

You may not qualify if:

• 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.).
• History of exposure to active TB, and/or history or current evidence of TB infection.
• Positive serology results at Screening for hepatitis B, hepatitis C or HIV.
• Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit.
• History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit
• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (39)

AkesoBio Investigative Site 2037, The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

AkesoBio Investigative Site 2036, The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Location

AkesoBio Investigative Site 1001, Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

AkesoBio Investigative Site 2044, Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

AkesoBio Investigative Site 2023, Xinqiao Hospital Medical University

Chongqing, Chongqing Municipality, China

Location

AkesoBio Investigative Site 2024, Chongqing Three Gorges Medical College

Chongqing, Chongqing Municipality, China

Location

AkesoBio Investigative Site 2040, Chongqing Traditional Chinese Medicine Hospital

Chongqing, Chongqing Municipality, China

Location

AkesoBio Investigative Site 2052, The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

AkesoBio Investigative Site 2038, The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

AkesoBio Investigative Site 2022, Dongguan People's Hospital

Dongguan, Guangdong, China

Location

AkesoBio Investigative Site 1002, Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

AkesoBio Investigative Site 2003, Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

AkesoBio Investigative Site 2049, The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Location

AkesoBio Investigative Site 2004, The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Location

AkesoBio Investigative Site 2001, Affiliated Hospital of Chengde medical university

Chengde, Hebei, China

Location

AkesoBio Investigative Site 2010, Nanyang First People's Hospital National Third Class A Hospital

Nanyang, Henan, China

Location

AkesoBio Investigative Site 2051, Jingzhou Central Hospital

Jingzhou, Hubei, China

Location

AkesoBio Investigative Site 1005, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

AkesoBio Investigative Site 2046, The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

AkesoBio Investigative Site 2008, The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Location

AkesoBio Investigative Site 2048, The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

Location

AkesoBio Investigative Site 2050, Wuxi Second People's Hospital

Wuxi, Jiangsu, China

Location

AkesoBio Investigative Site 2025, Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Location

AkesoBio Investigative Site 2032, The First Affiliated Hospital of Gannan Medical College

Ganzhou, Jiangxi, China

Location

AkesoBio Investigative Site 2011, Northeast International Hospital

Shenyang, Liaoning, China

Location

AkesoBio Investigative Site 2039, Shandong Provincial Dermatology Hospital

Jinan, Shandong, China

Location

AkesoBio Investigative Site 2041, Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

AkesoBio Investigative Site 1003, Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, China

Location

AkesoBio Investigative Site 2027, Medical School of Yanan University

Xianyang, Shanxi, China

Location

AkesoBio Investigative Site 2029, West China Hospital，Sichuan University

Chengdu, Sichuan, China

Location

AkesoBio Investigative Site 2034, Chengdu Second People's Hospital

Chengdu, Sichuan, China

Location

AkesoBio Investigative Site 2013, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, Tianjin Municipality, China

Location

AkesoBio Investigative Site 2019, Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Location

AkesoBio Investigative Site 2043, First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

AkesoBio Investigative Site 1004, Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

AkesoBio Investigative Site 2006,Affiliated Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Location

AkesoBio Investigative Site 2007, Hangzhou Third People's Hospital

Hangzhou, Zhejiang, China

Location

AkesoBio Investigative Site 2035, The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

AkesoBio Investigative Site 2009, The First Hospital of Jiaxing

Jiaxing, Zhejiang, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: September 13, 2023
• Study Start: November 3, 2021
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (39)