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A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Moderate-to-severe Atopic Dermatitis

ConditionModerate-to-Severe Atopic Dermatitis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso

About this trial

This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of patients with moderate-to-severe atopic dermatitis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to understand the study and voluntarily sign the ICF.

Atopic dermatitis (AD) diagnosed at least 6 months before screening.

Eczema Area and Severity Index (EASI) score ≥16, Investigator's Global Assessment (IGA) score ≥3, and Body surface area (BSA) involvement ≥10% at both screening and baseline.

A weekly average of daily Peak Pruritus Numerical Rating Scale (P-NRS) score ≥4 at baseline.

Disqualifiers

Acute onset of AD within the first 4 weeks of randomization.

Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy or other systemic therapies used for AD within the 4 weeks before randomization.

Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)

Received or planned to receive live vaccine treatment within the 12 weeks before randomization or during the study period.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AK139 and placebo

    Biological/Vaccine

    AK139 plus placebo regimen 1-subcutaneous injection.

  • AK139

    Biological/Vaccine

    AK139 regimen 2-subcutaneous injection.

  • AK139 and placebo

    Biological/Vaccine

    AK139 plus placebo regimen 3-subcutaneous injection.

  • AK139

    Biological/Vaccine

    AK139 regimen 4-subcutaneous injection.

  • AK139 and placebo

    Biological/Vaccine

    AK139 plus placebo regimen 5-subcutaneous injection.

  • AK139 and placebo

    Biological/Vaccine

    AK139 plus placebo regimen 6-subcutaneous injection.

  • Placebo

    Biological/Vaccine

    Placebo-subcutaneous injection

Treatment groups

168 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Part 1: AK139 regimen 1Experimental treatment 1 intervention
Group B: Part 1: AK139 regimen 2Experimental treatment 1 intervention
Group C: Part 1: AK139 regimen 3Experimental treatment 1 intervention
Group D: Part 1: AK139 regimen 4Experimental treatment 1 intervention
Group E: Part 2: AK139 regimen 5Experimental treatment 1 intervention
Group F: Part 2: AK139 regimen 6Experimental treatment 1 intervention
Group G: Part 2: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity grading of Adverse Events (AE)(applicable to Part 1)

Time frame
Up to Week 16 (applicable to the Q4W dosing group); Up to Week 8 (applicable to the Q2W dosing group).
2

Percentage of patients who achieved Eczema Area and Severity Index (EASI)-75 (applicable to Part 2)

Time frame
at week 16

Secondary outcomes

1

Percentage of patients achieving an IGA score of 0 or 1 at each visit, with a reduction of ≥2 points from baseline

Time frame
Up to Week 24
2

Percentage change in affected Body Surface Area (BSA)

Time frame
Up to week 24
3

Percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores

Time frame
Up to week 24
4

Percentage changes in the Dermatology Life Quality Index (DLQI) score

Time frame
Up to week 24

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akeso

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: