For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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

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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +86 (0760) 8987 3999Email iconEmail Study Center

Study Details


Contition

Atopic Dermatitis

Age

18 - 75

Phase

PHASE1/PHASE2

Participants Needed

416

Est. Completion Date

Oct 30, 2024

Treatment Type

INTERVENTIONAL


Sponsor

Akeso

ClinicalTrials.gov NCT Identifier

NCT06035354

Study Number

AK120-102

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