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Atopic DermatitisPhase 2NCT06700499

A Study to Evaluate the Efficacy and Safety of AK120 in Subjects With Moderate to Severe Atopic Dermatitis

A Phase 2 study testing AK120 300mg Q2W (JAK inhibitor users need to double the initial dose) in people with Atopic Dermatitis, run by Akeso at 50 sites in China.

Completed

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

Official record
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Trial summary

This is a multicenter, open label phase II clinical study to evaluate the efficacy and safety 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 300mg Q2W (JAK inhibitor users need to double the initial dose)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
50 sitesChina
Study dates
8 Jul 2024to 11 Sep 2025
Phase
Phase 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 subjects aged ≥18≤75 years old.
  • Atopic dermatitis (AD) diagnosed at least half a year before screening.
  • Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
  • Subjects who are suitable for continue using biological treatment assessed by investigator

Who cannot join

  • Acute onset of AD within 4 weeks before drug administration.
  • The accompany disease have been assessed by the investigators during screening period as unsuitable for participation in this study.
  • Any history or symptoms of malignant tumors in any organ within 5 years prior to screening, regardless of whether treatment has been received and whether there are signs of recurrence or metastasis
  • Have a known or suspected history of immunosuppressive diseases, including a history of invasive infections.
  • Having undergone or planned major surgery within 4 weeks prior to drug administration, or unable to fully recover from surgery prior to drug administration.
  • any medical or psychological condition that puts subjects at risk or may affect the study results assessed by investigators.

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

China50 sites

  • Anyang District Hospital

    Anyang, Henan

  • Beijing Luhe Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality

  • Peking University Third Hospital

    Beijing, Beijing Municipality

  • Xiyuan Hospital of CACMS

    Beijing, Beijing Municipality

  • Cangzhou People's Hospital

    Cangzhou, Hebei

  • Changde First People's Hospital

    Changde, Hunan

  • XiangYa Hospital CentralSouth University

    Changsha, Hunan

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

  • Guangdong Provincial Dermatology Hospital

    Guangzhou, Guangdong

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • Affiliated Hangzhou First People's Hospital

    Hangzhou, Zhejiang

  • Hangzhou Third People's Hospital

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • The Affiliated Hospital of Inner Mongolia Medical College

    Hohhot, Inner Mongolia

  • Jiaxing Second Hospital

    Jiaxing, Zhejiang

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • Shandong First Medical University Affiliated Dermatology Hospital

    Jinan, Shandong

  • Jingzhou Central Hospital

    Jingzhou, Hubei

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • The Second Hospital & Clinical Medical School, Lanzhou University

    Lanzhou, Gansu

  • Liuzhou People's Hospital

    Liuzhou, Guangxi

  • The Second Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu

  • Ningbo No.2 Hospital

    Ningbo, Zhejiang

  • Qujing No.1 Hospital

    Qujing, Yunnan

  • Sanmenxia Central Hospital

    Sanmenxia, Henan

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai Municipality

  • Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital

    Shanghai, Shanghai Municipality

  • Second people's Hospital of Shenzhen

    Shenzhen, Guangdong

  • Shenzhen Hospital of University of Hong Kong

    Shenzhen, Guangdong

  • Shijiazhuang Hospital of Traditional Chinese Medicine

    Shijiazhuang, Hebei

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Taiyuan Central Hospital

    Taiyuan, Shanxi

  • Taizhou Central Hospital

    Taizhou, Zhejiang

  • The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin, Tianjin Municipality

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    Tianjin, Tianjin Municipality

  • Xinjiang Uygur Municipal People's Hospital

    Ürümqi, Xinjiang

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

  • Wuhan No.1 Hospital

    Wuhan, Hubei

  • Wuxi People's Hospital

    Wuxi, Jiangsu

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen, Fujian

  • People Hospital of Xingtai

    Xingtai, Hebei

  • The Second Affiliated Hospital of Xingtai Medical College

    Xingtai, Hebei

  • The Affiliated Hospital of Yanbian University Yanbian Hospital

    Yanbian, Jilin

  • Yantai Yuhuangding Hospital

    Yantai, Shandong

  • Yueyang Central Hospital

    Yueyang, Hunan

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu

Other trials in China

About this study

Official title: A Multicenter, Open Label Phase II Clinical Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis

This is a multicenter, open label phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.

Read the detailed description

This is a multicenter, open label phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period, treatment period and follow-up period) planned for each subject is approximately 25 weeks.

Being tested
AK120 300mg Q2W (JAK inhibitor users need to double the initial dose)
Medical subject headings
Dermatitis, Atopic

What participants receive

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

  • AK120 300mg Q2W (JAK inhibitor users need to double the initial dose)Drug

    AK120 300mg Q2W SC until week 14(JAK inhibitor users need to receive a first dose of 600mg SC)

Study groups in NCT06700499
Study groupRoleWhat they receive
AK120 300mg Q2W(Double the initial dose)ExperimentalAK120 600mg (first day) then 300mg Q2W SC until week 14.
Receives: Drug: AK120 300mg Q2W (JAK inhibitor users need to double the initial dose)

What is being measured

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

  1. Incidence of treatment emergent adverse events (TEAEs)

    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: through study completion, an average of 25 weeks

Secondary outcomes (5)

  1. Eczema Area and Severity Index (EASI) score

    Percentage change in EASI score from baseline. EASI score is to assesses the extent and severity of eczema in four body regions with the score ranges from 0 to 72. The higher the score, the more severe the eczema.

    Measured: baseline to week 20

  2. Investigator's Global Assessment (IGA) 0/1

    Percentage of subjects who achieved 0/1 in the IGA. The IGA is an assessment instrument used in clinical studies to rate the severity of atopic dermatitis globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).

    Measured: from baseline to week 20

  3. Affected body surface area (BSA) score

    Percentage change in BSA score from baseline. Body surface area affected by atopic dermatitis will be assessed for each section of the body (0-100%) and will be reported as a percentage of all major body sections combined.

    Measured: from baseline to week 20

  4. Area under the curve(AUC) of AK120

    Assessment of AUC of AK120.

    Measured: before drug administration at week 0/4/8/12/16

  5. Anti-drug antibodies (ADA) of AK120

    Percentage of subjects with detectable anti drug antibodies (ADA) of AK120.

    Measured: before drug administration at week 0/4/8/16/20

Timeline

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

  1. First posted22 Nov 2024
  2. Study start8 Jul 2024
  3. Primary completion31 Jul 2025
  4. Study completion11 Sep 2025

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06700499
Sponsor's protocol ID
AK120-207
Status last verified
Mar 2026
First submitted
14 Nov 2024
Last updated
17 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK120 300mg Q2W (JAK inhibitor users need to double the initial dose) in people with Atopic Dermatitis, run by Akeso at 50 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 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

Incidence of treatment emergent adverse events (TEAEs) (time frame: through study completion, an average of 25 weeks). 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 NCT06700499.

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 17 Mar 2026.

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