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A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in Subjects With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06035354
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
Akeso

Study Description
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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 to severe atopic dermatitis.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: AK120 Drug: Placebo Phase 1 Phase 2

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 dermatitis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 to Severe Atopic Dermatitis
Actual Study Start Date : November 3, 2021
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : October 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: AK120 150 mg in phase Ib
subcutaneous injection once a week for 4 weeks.
 Drug: AK120
subcutaneous injection once a week
Experimental: AK120 300mg in phase Ib
subcutaneous injection once a week for 4 weeks.
 Drug: AK120
subcutaneous injection once a week
Placebo Comparator: Placebo Comparator: Placebo in phase Ib
subcutaneous injection once a week for 4 weeks.
 Drug: Placebo
subcutaneous injection once a week.
Experimental: AK120 150mg in phase II
subcutaneous injection every 2 weeks for 50 weeks.
 Drug: AK120
subcutaneous injection every 2 weeks.
Experimental: AK120 300mg in phase II
subcutaneous injection every 2 weeks for 50 weeks.
 Drug: AK120
subcutaneous injection every 2 weeks.
Experimental: AK120 450mg in phase II
subcutaneous injection every 2 weeks for 50 weeks.
 Drug: AK120
subcutaneous injection every 2 weeks.
Placebo Comparator: Placebo Comparator: Placebo in phase II
subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 4 and Regimen 5, subcutaneous injection at week 16, after primary endpoint evaluation.
 Drug: Placebo
subcutaneous injection every 2 weeks for 16 weeks then crossover to AK120 Regimen 4 and Regimen 5.
Experimental: AK120 150mg in phase II extension
subcutaneous injection every 2 weeks for 14 weeks.
 Drug: AK120
subcutaneous injection every 2 weeks
Experimental: AK120 300mg in phase II extension
subcutaneous injection every 2 weeks for 14 weeks.
 Drug: AK120
subcutaneous injection every 2 weeks.
Experimental: AK120 450mg in phase II extension
subcutaneous injection every 2 weeks for 14 weeks.
 Drug: AK120
subcutaneous injection every 2 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Phase Ib [ Time Frame: Baseline to week 12 ]
    Incidence of treatment emergent AE . An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  2. Phase Ib [ Time Frame: Baseline to week 12 ]
    T1/2 of AK120. Assessment of half-life(t1/2) of AK120.

  3. Phase Ib [ Time Frame: Baseline to week 12 ]
    AUC of AK120. Assessment of Area under the curve(AUC) of AK120

  4. Phase Ib [ Time Frame: Baseline to week 12 ]
    Cmax of AK120. Assessment of Peak concentration(Cmax) of AK120

  5. Phase Ib [ Time Frame: Baseline to week 12 ]
    Tmax of AK120. Assessment of Time to peak(Tmax) of AK120

  6. Phase II [ Time Frame: at week 16 ]
    Percentage of subjects who achieved (Eczema Area and Severity Index)EASI-75

  7. Phase II Extension Study [ Time Frame: Baseline to week 24 ]
    Incidence of treatment emergent AE . An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.


Secondary Outcome Measures :
  1. Phase Ib [ Time Frame: Baseline to week 12 ]
    Percentage of subjects with detectable anti AK120 antibodies (ADA).

  2. Phase Ib [ Time Frame: Baseline to week 12 ]

    Percentage of subjects who achieved 0/1 in the Investigator's Global Assessment (IGA)(on a 6-point scale) .

    Lower score of IGA mean better outcome, higher score mean worse outcome


  3. Phase II [ Time Frame: Baseline to week 58 ]

    Percentage of subjects who achieved EASI-50 (≥50% improvement from baseline) /EASI-75 (≥75% improvement from baseline) response at each visit.

    Higher score mean better outcome, lower score mean worse outcome


  4. Phase II [ Time Frame: Baseline to week 58 ]
    Percentage change in EASI scores from baseline at each visit. Higher score mean better outcome, lower score mean worse outcome

  5. Phase II Extension Study [ Time Frame: Baseline to week 24 ]

    Percentage of subjects who achieved EASI-50 (≥50% improvement from baseline) /EASI-75 (≥75% improvement from baseline) response at each visit.

    Higher score mean better outcome, lower score mean worse outcome


  6. Phase II Extension Study [ Time Frame: Baseline to week 24 ]
    Percentage change in EASI scores from baseline at each visit. Higher score mean better outcome, lower score mean worse outcome


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female with age 18 - 75 years (inclusive).
  2. Atopic dermatitis (AD) diagnosed at least half an year before screening.
  3. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
  4. Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months.

Exclusion Criteria:

  1. 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.).
  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.
Contacts and Locations
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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): NCT06035354


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

Locations
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Sponsors and Collaborators
Akeso
More Information
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Responsible Party: Akeso
ClinicalTrials.gov Identifier: NCT06035354    
Other Study ID Numbers: AK120-102
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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