Evaluating AK120 for treating moderate to severe atopic dermatitis

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

Phase 2 Interventional Akeso · NCT06700499

This study is testing a new treatment called AK120 to see if it can help people with moderate to severe atopic dermatitis feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAkeso Industry-sponsored
Locations50 sites (Beijing, Beijing and 49 other locations)
Trial IDNCT06700499 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label phase II clinical study aims to assess the efficacy and safety of AK120 in patients suffering from moderate to severe atopic dermatitis. Participants will receive AK120 at a dosage of 300mg every two weeks, with adjustments for those using JAK inhibitors. The study will span approximately 25 weeks, including screening, treatment, and follow-up periods. The primary focus is on patients with significant disease severity, as indicated by specific scoring criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of moderate to severe atopic dermatitis.

Not a fit: Patients with acute onset of atopic dermatitis or those with a history of certain malignancies or immunosuppressive diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief and improved quality of life for patients with moderate to severe atopic dermatitis.

How similar studies have performed: Other studies evaluating similar JAK inhibitors have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Male or female subjects aged ≥18≤75 years old.
2. Atopic dermatitis (AD) diagnosed at least half a year before screening.
3. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
4. Subjects who are suitable for continue using biological treatment assessed by investigator

Exclusion Criteria:

1. Acute onset of AD within 4 weeks before drug administration.
2. The accompany disease have been assessed by the investigators during screening period as unsuitable for participation in this study.
3. 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
4. Have a known or suspected history of immunosuppressive diseases, including a history of invasive infections.
5. Having undergone or planned major surgery within 4 weeks prior to drug administration, or unable to fully recover from surgery prior to drug administration.
6. any medical or psychological condition that puts subjects at risk or may affect the study results assessed by investigators.

Where this trial is running

Beijing, Beijing and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Atopic Dermatitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.