Clinical trial NCT05048056: Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis
Official title: A Phase 2, Multi-center, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of AK120 in Adult Subjects With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Monoclonal Antibodies
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2021-09-17
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study, conducted in subjects with moderate-to-severe atopic dermatitis.

Detailed description: This phase 2 study is designed to explore the efficacy and safety, as well as pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of dose-ranging AK120 compared to placebo, which will generate information regarding the selection of dosing regimens with AK120 monotherapy treatment in adult subjects with moderate-to-severe AD.

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.

Eligibility criteria: Key Inclusion Criteria:

1. Male or female, over the age of 18
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.

Key Exclusion Criteria:

1. Inadequate washout period for prior drug therapy (eg. corticosteroids, immunosuppressive/ immunomodulating, biologics, phototherapy, Chinese traditional medicine, anti-infective agents).
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.

Primary outcomes:
measure: Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response
timeFrame: At week 16
Secondary outcomes:
measure: Proportion of subjects achieving the Investigator Global Assessment (IGA, on a 5-point scale) for clear (0) or almost clear (1)
timeFrame: At week 16
measure: Change in SCORing Atopic Dermatitis (SCORAD)
timeFrame: Baseline to Week 38
measure: Change in Pruritus-Numerical Rating Scale (P-NRS)
timeFrame: Baseline to Week 38
measure: Change in Body Surface Area (BSA) of AD involvement
timeFrame: Baseline to Week 38
measure: Change in Patient Oriented Eczema Measure (POEM)
timeFrame: Baseline to Week 38
measure: Individual subject AK120 concentrations in serum at different time points after AK120 administration
timeFrame: Baseline to Week 38
measure: Change in pharmacodynamics studies TARC/CCL17 and IgE
timeFrame: Baseline to week 24
measure: Anti-drug antibodies(ADAs)
timeFrame: Baseline to Week 38
measure: Adverse events(AEs)/serious adverse events(SAEs)
timeFrame: Baseline to Week 38
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: AkesoBio Investigative Site 2003
state: Arkansas
city: Canoga Park
country: United States
facility: AkesoBio Investigative Site 2010
state: California
city: San Diego
country: United States
facility: AkesoBio Investigative Site 2021
state: California
city: San Diego
country: United States
facility: AkesoBio Investigative Site 2023
state: California
city: San Francisco
country: United States
facility: AkesoBio Investigative Site 2017
state: California
city: Sherman Oaks
country: United States
facility: AkesoBio Investigative Site 2020
state: California
city: Hialeah
country: United States
facility: AkesoBio Investigative Site 2009
state: Florida
city: Hollywood
country: United States
facility: AkesoBio Investigative Site 2001
state: Florida
city: Miami
country: United States
facility: AkesoBio Investigative Site 2011
state: Florida
city: Weston
country: United States
facility: AkesoBio Investigative Site 2002
state: Florida
city: Ridgeland
country: United States
facility: AkesoBio Investigative Site 2022
state: Mississippi
city: Las Vegas
country: United States
facility: AkesoBio Investigative Site 2015
state: Nevada
city: Spartanburg
country: United States
facility: AkesoBio Investigative Site 2013
state: South Carolina
city: Rapid City
country: United States
facility: AkesoBio Investigative Site 2005
state: South Dakota
city: Houston
country: United States
facility: AkesoBio Investigative Site 2004
state: Texas
city: Houston
country: United States
facility: AkesoBio Investigative Site 2018
state: Texas
city: Sydney
country: Australia
facility: AkesoBio Investigative Site 3003
state: New South Wales
city: Woolloongabba
country: Australia
facility: AkesoBio Investigative Site 3002
state: Queensland
city: Camberwell
country: Australia
facility: AkesoBio Investigative Site 3001
state: Victoria
city: Auckland
country: New Zealand
facility: AkesoBio Investigative Site 4003
city: Auckland
country: New Zealand
facility: AkesoBio Investigative Site 4001
city: Christchurch
country: New Zealand
facility: AkesoBio Investigative Site 4005
city: Hamilton
country: New Zealand
facility: AkesoBio Investigative Site 4004
city: Wellington
country: New Zealand
facility: AkesoBio Investigative Site 4004
Study officials:
References: