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

A Phase 1/2 study testing AK120 in people with Atopic Dermatitis, run by Akeso at 39 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Atopic Dermatitis
What is being tested?: AK120
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 427 participants
Where: 39 sitesChina
Study dates: 3 Nov 2021to 21 Jun 2024
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

39 sites in 1 country.

City, postcode or hospital

39 sites in 1 country

China39 sites

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

Other trials in China

About this study

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

Read the 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.

Conditions: Atopic Dermatitis
Being tested: AK120, Placebo
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AK120Drug
subcutaneous injection once a week
AK120Drug
subcutaneous injection once a week
PlaceboDrug
subcutaneous injection once a week.
AK120Drug
subcutaneous injection every 2 weeks.
AK120Drug
subcutaneous injection every 2 weeks.
AK120Drug
subcutaneous injection every 2 weeks.
PlaceboDrug
subcutaneous injection every 2 weeks for 16 weeks then crossover to AK120 Regimen 4 and Regimen 5.
AK120Drug
subcutaneous injection every 2 weeks
AK120Drug
subcutaneous injection every 2 weeks.
AK120Drug
subcutaneous injection every 2 weeks.

Study groups in NCT06035354
Study group	Role	What they receive
AK120 150 mg in phase Ib	Experimental	subcutaneous injection once a week for 4 weeks. Receives: Drug: AK120
AK120 300mg in phase Ib	Experimental	subcutaneous injection once a week for 4 weeks. Receives: Drug: AK120
Placebo Comparator: Placebo in phase Ib	Placebo comparator	subcutaneous injection once a week for 4 weeks. Receives: Drug: Placebo
AK120 150mg in phase II	Experimental	subcutaneous injection every 2 weeks for 50 weeks. Receives: Drug: AK120
AK120 300mg in phase II	Experimental	subcutaneous injection every 2 weeks for 50 weeks. Receives: Drug: AK120
AK120 450mg in phase II	Experimental	subcutaneous injection every 2 weeks for 50 weeks. Receives: 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. Receives: Drug: Placebo
AK120 150mg in phase II extension	Experimental	subcutaneous injection every 2 weeks for 14 weeks. Receives: Drug: AK120
AK120 300mg in phase II extension	Experimental	subcutaneous injection every 2 weeks for 14 weeks. Receives: Drug: AK120
AK120 450mg in phase II extension	Experimental	subcutaneous injection every 2 weeks for 14 weeks. Receives: Drug: AK120

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to week 12
Phase Ib
T1/2 of AK120. Assessment of half-life(t1/2) of AK120.
Measured: Baseline to week 12
Phase Ib
AUC of AK120. Assessment of Area under the curve(AUC) of AK120
Measured: Baseline to week 12
Phase Ib
Cmax of AK120. Assessment of Peak concentration(Cmax) of AK120
Measured: Baseline to week 12
Phase Ib
Tmax of AK120. Assessment of Time to peak(Tmax) of AK120
Measured: Baseline to week 12
Phase II
Percentage of subjects who achieved (Eczema Area and Severity Index)EASI-75
Measured: 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.
Measured: Baseline to week 24

Secondary outcomes (6)

Phase Ib
Percentage of subjects with detectable anti AK120 antibodies (ADA).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Nov 202121 Jun 2024

First posted13 Sep 2023
Study start3 Nov 2021
Primary completion21 Jun 2024
Study completion21 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
More trials run by AkesoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 427 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06035354
Sponsor's protocol ID: AK120-102
Status last verified: Mar 2025
First submitted: 2 Jun 2023
Last updated: 5 Mar 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06035354
Acronym / sponsor ID: AK120-102
Conditions: Atopic Dermatitis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 427 participants (actual)
Lead sponsor: AkesoIndustry (pharma, biotech, devices)
Study start: 3 Nov 2021 (actual)
Primary completion: 21 Jun 2024 (actual)
Study completion: 21 Jun 2024 (actual)
First posted: 13 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
AK120 150 mg in phase Ib	Experimental	Drug: AK120subcutaneous injection once a week for 4 weeks.
AK120 300mg in phase Ib	Experimental	Drug: AK120subcutaneous injection once a week for 4 weeks.
Placebo Comparator: Placebo in phase Ib	Placebo comparator	Drug: Placebosubcutaneous injection once a week for 4 weeks.
AK120 150mg in phase II	Experimental	Drug: AK120subcutaneous injection every 2 weeks for 50 weeks.
AK120 300mg in phase II	Experimental	Drug: AK120subcutaneous injection every 2 weeks for 50 weeks.
AK120 450mg in phase II	Experimental	Drug: AK120subcutaneous injection every 2 weeks for 50 weeks.
Placebo Comparator: Placebo in phase II	Placebo comparator	Drug: Placebosubcutaneous injection every 2 weeks, then crossover to AK120 Regimen 4 and Regimen 5, subcutaneous injection at week 16, after primary endpoint evaluation.
AK120 150mg in phase II extension	Experimental	Drug: AK120subcutaneous injection every 2 weeks for 14 weeks.
AK120 300mg in phase II extension	Experimental	Drug: AK120subcutaneous injection every 2 weeks for 14 weeks.
AK120 450mg in phase II extension	Experimental	Drug: AK120subcutaneous injection every 2 weeks for 14 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AK120subcutaneous injection once a week	Drug	AK120 150 mg in phase Ib
AK120subcutaneous injection once a week	Drug	AK120 300mg in phase Ib
Placebosubcutaneous injection once a week.	Drug	Placebo Comparator: Placebo in phase Ib
AK120subcutaneous injection every 2 weeks.	Drug	AK120 150mg in phase II
AK120subcutaneous injection every 2 weeks.	Drug	AK120 300mg in phase II
AK120subcutaneous injection every 2 weeks.	Drug	AK120 450mg in phase II
Placebosubcutaneous injection every 2 weeks for 16 weeks then crossover to AK120 Regimen 4 and Regimen 5.	Drug	Placebo Comparator: Placebo in phase II
AK120subcutaneous injection every 2 weeks	Drug	AK120 150mg in phase II extension
AK120subcutaneous injection every 2 weeks.	Drug	AK120 300mg in phase II extension
AK120subcutaneous injection every 2 weeks.	Drug	AK120 450mg in phase II extension

Primary outcome

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

6 secondary outcomes

Phase Ib
Time frame: Baseline to week 12
Phase Ib
Time frame: Baseline to week 12
Phase II
Time frame: Baseline to week 58
Phase II
Time frame: Baseline to week 58
Phase II Extension Study
Time frame: Baseline to week 24
Phase II Extension Study
Time frame: Baseline to week 24

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
Individual participant dataSharing planned: No

Related trials for Atopic Dermatitis

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

39 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AK120 in people with Atopic Dermatitis, run by Akeso at 39 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib (time frame: Baseline to week 12). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06035354.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.