Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT05048056 | Terminated Phase 2 FDA Drug

• 1 other identifier: AK120-203
• Study Type: interventional
• Target: 79
• Locations: 3 countries
• Sites: 24

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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Monoclonal Antibodies

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response

  At week 16

Secondary Outcomes (9)

• Proportion of subjects achieving the Investigator Global Assessment (IGA, on a 5-point scale) for clear (0) or almost clear (1)

  At week 16

• Change in SCORing Atopic Dermatitis (SCORAD)

  Baseline to Week 38

• Change in Pruritus-Numerical Rating Scale (P-NRS)

  Baseline to Week 38

• Change in Body Surface Area (BSA) of AD involvement

  Baseline to Week 38

• Change in Patient Oriented Eczema Measure (POEM)

  Baseline to Week 38

Study Arms (3)

AK120 Regimen 1

EXPERIMENTAL

AK120 Regimen 1- subcutaneous injection every 2 weeks for 30 weeks.

Drug: AK120

AK120 Regimen 2

EXPERIMENTAL

AK120 Regimen 2- subcutaneous injection every 2 weeks for 30 weeks.

Drug: AK120

Placebo to AK120

EXPERIMENTAL

Placebo subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 1, subcutaneous injection at Week16, after primary endpoint evaluation

Drug: Placebo; Drug: AK120

Interventions

Placebo DRUG

Placebo subcutaneous injection every 2 weeks for 16 weeks then Crossover to AK120 Regimen 1

Placebo to AK120

AK120 DRUG

AK120 Regimen 1- subcutaneous injection every 2 weeks.

AK120 Regimen 1; Placebo to AK120

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, over the age of 18
• Chronic atopic dermatitis (AD) diagnosed at least 1 year.
• 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.
• Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months.

You may not qualify if:

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

Sponsors & Collaborators

• Akesobio Australia Pty Ltd: lead

Study Sites (24)

AkesoBio Investigative Site 2003

Little Rock, Arkansas, 72204, United States

Location

AkesoBio Investigative Site 2010

Canoga Park, California, 91303, United States

Location

AkesoBio Investigative Site 2021

San Diego, California, 92119, United States

Location

AkesoBio Investigative Site 2023

San Diego, California, 92120, United States

Location

AkesoBio Investigative Site 2017

San Francisco, California, 94127, United States

Location

AkesoBio Investigative Site 2020

Sherman Oaks, California, 91043, United States

Location

AkesoBio Investigative Site 2009

Hialeah, Florida, 33016, United States

Location

AkesoBio Investigative Site 2001

Hollywood, Florida, 33021, United States

Location

AkesoBio Investigative Site 2011

Miami, Florida, 33155, United States

Location

AkesoBio Investigative Site 2002

Weston, Florida, 33331, United States

Location

AkesoBio Investigative Site 2022

Ridgeland, Mississippi, 39157, United States

Location

AkesoBio Investigative Site 2015

Las Vegas, Nevada, 89145, United States

Location

AkesoBio Investigative Site 2013

Spartanburg, South Carolina, 29303, United States

Location

AkesoBio Investigative Site 2005

Rapid City, South Dakota, 57702, United States

Location

AkesoBio Investigative Site 2004

Houston, Texas, 77065, United States

Location

AkesoBio Investigative Site 2018

Houston, Texas, 77074, United States

Location

AkesoBio Investigative Site 3003

Sydney, New South Wales, 2145, Australia

Location

AkesoBio Investigative Site 3002

Woolloongabba, Queensland, 4102, Australia

Location

AkesoBio Investigative Site 3001

Camberwell, Victoria, 3145, Australia

Location

AkesoBio Investigative Site 4003

Auckland, 0626, New Zealand

Location

AkesoBio Investigative Site 4001

Auckland, 1010, New Zealand

Location

AkesoBio Investigative Site 4005

Christchurch, 8013, New Zealand

Location

AkesoBio Investigative Site 4004

Hamilton, 3204, New Zealand

Location

AkesoBio Investigative Site 4004

Wellington, 6242, New Zealand

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 17, 2021
• Study Start: September 30, 2021
• Primary Completion: May 17, 2023
• Study Completion: May 17, 2023
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); US (16); NZ (5)