Status:
COMPLETED
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in Subjects With Atopic Dermatitis
Lead Sponsor:
Akeso
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2024
Estimated Enrollment :
427 Patients enrolled
Trial Details
Trial ID
NCT06035354
Start Date
November 3 2021
End Date
June 21 2024
Last Update
March 5 2025
Active Locations (39)
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1
AkesoBio Investigative Site 2037, The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
2
AkesoBio Investigative Site 2036, The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
3
AkesoBio Investigative Site 1001, Peking University People's Hospital
Beijing, Beijing Municipality, China
4
AkesoBio Investigative Site 2044, Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China