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

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ClinicalTrials.gov Identifier: NCT05048056
Recruitment Status : Not yet recruiting
First Posted : September 17, 2021
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
Akeso ( Akesobio Australia Pty Ltd )

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Placebo Drug: AK120 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blinded
Primary Purpose: Treatment
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
Estimated Study Start Date : September 10, 2021
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: AK120 Regimen 1
AK120 Regimen 1- subcutaneous injection every 2 weeks for 30 weeks.
Drug: AK120
AK120 Regimen 1- subcutaneous injection every 2 weeks.

Experimental: AK120 Regimen 2
AK120 Regimen 2- subcutaneous injection every 2 weeks for 30 weeks.
Drug: AK120
AK120 Regimen 2- subcutaneous injection every 2 weeks

Experimental: Placebo to AK120
Placebo subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 1, subcutaneous injection at Week16, after primary endpoint evaluation
Drug: Placebo
Placebo subcutaneous injection every 2 weeks for 16 weeks then Crossover to AK120 Regimen 1

Drug: AK120
AK120 Regimen 1- subcutaneous injection every 2 weeks.




Primary Outcome Measures :
  1. Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response [ Time Frame: At week 16 ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving the Investigator Global Assessment (IGA, on a 5-point scale) for clear (0) or almost clear (1) [ Time Frame: At week 16 ]
  2. Change in SCORing Atopic Dermatitis (SCORAD) [ Time Frame: Baseline to Week 38 ]
  3. Change in Pruritus-Numerical Rating Scale (P-NRS) [ Time Frame: Baseline to Week 38 ]
  4. Change in Body Surface Area (BSA) of AD involvement [ Time Frame: Baseline to Week 38 ]
  5. Change in Patient Oriented Eczema Measure (POEM) [ Time Frame: Baseline to Week 38 ]
  6. Individual subject AK120 concentrations in serum at different time points after AK120 administration [ Time Frame: Baseline to Week 38 ]
  7. Change in pharmacodynamics studies TARC/CCL17 and IgE [ Time Frame: Baseline to week 24 ]
  8. Anti-drug antibodies(ADAs) [ Time Frame: Baseline to Week 38 ]
  9. Adverse events(AEs)/serious adverse events(SAEs) [ Time Frame: Baseline to Week 38 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05048056


Contacts
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Contact: Miao Wang +86 (0760) 8987 3999 global.trials@akesobio.com

Locations
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United States, California
AkesoBio Investigative Site 2006
San Francisco, California, United States, 94127
United States, Florida
AkesoBio Investigative Site 2001
Hollywood, Florida, United States, 33021
AkesoBio Investigative Site 2005
Jacksonville, Florida, United States, 32256
AkesoBio Investigative Site 2004
Orlando, Florida, United States, 32801
AkesoBio Investigative Site 2002
Weston, Florida, United States, 33331
United States, South Carolina
AkesoBio Investigative Site 2003
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
AkesoBio Investigative Site 2008
Rapid City, South Dakota, United States, 57702
United States, Texas
AkesoBio Investigative Site 2007
Houston, Texas, United States, 77031
Australia, New South Wales
AkesoBio Investigative Site 3003
Sydney, New South Wales, Australia, 2145
Australia, Queensland
AkesoBio Investigative Site 3002
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
AkesoBio Investigative Site 3001
Camberwell, Victoria, Australia, 3145
New Zealand
AkesoBio Investigative Site 4002
Auckland, New Zealand, 0626
AkesoBio Investigative Site 4001
Auckland, New Zealand, 1010
AkesoBio Investigative Site 4003
Hamilton, New Zealand, 3206
AkesoBio Investigative Site 4003
Wellington, New Zealand, 6021
Sponsors and Collaborators
Akesobio Australia Pty Ltd
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Responsible Party: Akesobio Australia Pty Ltd
ClinicalTrials.gov Identifier: NCT05048056    
Other Study ID Numbers: AK120-203
First Posted: September 17, 2021    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Akeso ( Akesobio Australia Pty Ltd ):
Atopic Dermatitis
Monoclonal Antibodies
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases