Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT05048056
Last Updated: 2025-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
79 participants
INTERVENTIONAL
2021-09-30
2023-05-17
Brief Summary
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Detailed Description
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Primary Objectives:
• To evaluate the efficacy of AK120 in the treatment of adult subjects with moderate-to-severe Atopic Dermatitis (AD).
Secondary Objectives:
* To evaluate the safety of AK120 in the treatment of adult subjects with moderate-to-severe AD.
* To evaluate the Pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AK120 in adult subjects with moderate-to-severe AD.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AK120 Regimen 1
AK120 Regimen 1- subcutaneous injection every 2 weeks for 30 weeks.
AK120
AK120 Regimen 1- subcutaneous injection every 2 weeks.
AK120 Regimen 2
AK120 Regimen 2- subcutaneous injection every 2 weeks for 30 weeks.
AK120
AK120 Regimen 2- subcutaneous injection every 2 weeks
Placebo to AK120
Placebo subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 1, subcutaneous injection at Week16, after primary endpoint evaluation
Placebo
Placebo subcutaneous injection every 2 weeks for 16 weeks then Crossover to AK120 Regimen 1
AK120
AK120 Regimen 1- subcutaneous injection every 2 weeks.
Interventions
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Placebo
Placebo subcutaneous injection every 2 weeks for 16 weeks then Crossover to AK120 Regimen 1
AK120
AK120 Regimen 1- subcutaneous injection every 2 weeks.
AK120
AK120 Regimen 2- subcutaneous injection every 2 weeks
Eligibility Criteria
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Inclusion Criteria
2. Chronic atopic dermatitis (AD) diagnosed at least 1 year.
3. Subject with EASI score ≥16, IGA ≥ 3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe), ≥ 10% body surface area (BSA) of AD involvement.
4. Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Akesobio Australia Pty Ltd
INDUSTRY
Responsible Party
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Locations
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AkesoBio Investigative Site 2003
Little Rock, Arkansas, United States
AkesoBio Investigative Site 2010
Canoga Park, California, United States
AkesoBio Investigative Site 2021
San Diego, California, United States
AkesoBio Investigative Site 2023
San Diego, California, United States
AkesoBio Investigative Site 2017
San Francisco, California, United States
AkesoBio Investigative Site 2020
Sherman Oaks, California, United States
AkesoBio Investigative Site 2009
Hialeah, Florida, United States
AkesoBio Investigative Site 2001
Hollywood, Florida, United States
AkesoBio Investigative Site 2011
Miami, Florida, United States
AkesoBio Investigative Site 2002
Weston, Florida, United States
AkesoBio Investigative Site 2022
Ridgeland, Mississippi, United States
AkesoBio Investigative Site 2015
Las Vegas, Nevada, United States
AkesoBio Investigative Site 2013
Spartanburg, South Carolina, United States
AkesoBio Investigative Site 2005
Rapid City, South Dakota, United States
AkesoBio Investigative Site 2004
Houston, Texas, United States
AkesoBio Investigative Site 2018
Houston, Texas, United States
AkesoBio Investigative Site 3003
Sydney, New South Wales, Australia
AkesoBio Investigative Site 3002
Woolloongabba, Queensland, Australia
AkesoBio Investigative Site 3001
Camberwell, Victoria, Australia
AkesoBio Investigative Site 4003
Auckland, , New Zealand
AkesoBio Investigative Site 4001
Auckland, , New Zealand
AkesoBio Investigative Site 4005
Christchurch, , New Zealand
AkesoBio Investigative Site 4004
Hamilton, , New Zealand
AkesoBio Investigative Site 4004
Wellington, , New Zealand
Countries
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Other Identifiers
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AK120-203
Identifier Type: -
Identifier Source: org_study_id
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