Eczema (Atopic Dermatitis)
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Eczema (Atopic Dermatitis)
AK002-018 Enrolling

Research Trial Testing Investigational Treatment for Eczema (26-40 Weeks)


Treatment: Injection Age: 18 Years

Individuals aged 18 to 80 years with chronic atopic dermatitis (eczema) that has been present for at least 3 years, may qualify for this study.  Participants must have a documented recent history of inadequate response to treatment with topical medications, or for whom topical treatments are otherwise medically inadvisable.  Qualified adults must also have moderate to severe eczema, with involvement of at least 10% or more body surface area.

Participants will receive investigational medication (active study drug) or placebo via injection every 2 weeks.  During the open-label extension period, individuals may be eligible to receive 7 additional doses of active study drug.  Study medication and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses will also be provided.

Study participation lasts approximately 26-40 weeks and involves about 12-19 visits to the study centre.


The following information is from ClinicalTrials.gov

Last Update Posted: October 02, 2022

Official Title

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Lirentelimab in Adult Subjects With Moderate-to-Severe Atopic Dermatitis Inadequately Controlled by Topical Treatments

ClinicalTrials.gov ID

NCT05155085

Sponsor

Allakos Inc.

Study Description

  • Brief Summary:

    This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous lirentelimab (AK002), given every 2 weeks for 7 doses, in adult subjects with moderate-to-severe AD inadequately controlled by topical treatments. Subjects who complete the randomized, double-blind, placebo-controlled treatment period may have the option to enroll in an open-label extension period and receive up to 7 doses of subcutaneous lirentelimab.

  • Condition or Disease:

    Atopic Dermatitis

  • Intervention/Treatment:

    Drug: AK002
    Other: Placebo
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and 80 Years (Adult)

  • Sexes Eligible for Study:

    All

Key Inclusion Criteria:

Subject is able to understand the information on the study, has the capacity to consent, and has provided written informed consent.
Male or female aged ≥18 and ≤80 years at the time of signing the informed consent form.
Chronic AD (as defined by the American Academy of Dermatology Consensus Criteria) (Eichenfield, 2014) that has been present for at least 3 years before the screening visit.
Documented recent history of inadequate response to treatment with topical medications such as topical corticosteroids, calcineurin inhibitors, JAK inhibitors, or PDE4 inhibitors (crisaborole) for at least 4 weeks in the 6 months prior to screening, or subjects for whom these topical treatments are otherwise medically inadvisable (e.g., because of side effects or safety risks).
Subjects who are biologic naive or biologic-exposed. Biologic-exposed includes patients who have demonstrated secondary loss of response, intolerance, or lack of continued access to biologics due to economic reasons.
EASI score of ≥16 at screening and at baseline.
Involvement of at least 10% or more of BSA at screening and at baseline.
An IGA score of 3 or above on a scale from 0-4 at screening and at baseline.
The subject should have applied a stable dose of non-medicated, non-prescription, topical emollient at least twice daily for 7 consecutive days immediately before the baseline visit.

Key Exclusion Criteria:

Current use of biologics for any indication.
Demonstrated lack of primary response to treatment with a biologic for the treatment of AD defined as no response to treatment despite complete adherence to the prescribed regimen for at least 3 months (primary non-responders).
Use of any of the following treatments within 4 weeks prior to the baseline visit or any condition that in the opinion of the Investigator is likely to require such treatment(s) during the first 4 weeks of study treatment: (i) phototherapy for AD; (ii) immunosuppressive or immunomodulatory drugs, including but not limited to systemic calcineurin inhibitors (e.g., cyclosporin, tacrolimus), mTOR inhibitors (e.g., sirolimus, everolimus), anti-metabolites (e.g., azathioprine, methotrexate, 6-mercaptopurine, leflunomide, mycophenolate mofetil), alkylating agents (e.g., cyclophosphamide), TNF inhibitors (e.g., infliximab, adalimumab), eosinophil depleting drugs (e.g., pramipexole), and systemic corticosteroids; (iii) oral JAK inhibitors within 8 weeks of the baseline visit.
Treatment with biologics: (i) any cell-depleting agents including but not limited to rituximab within 6 months prior to the baseline visit or until lymphocyte count returns to normal, whichever is longer; (ii) other biologics (e.g., dupilumab, omalizumab, etc) within 5 half-lives, if known, or 8 weeks prior to baseline visit, whichever is longer.
Use of any topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors (e.g., ruxolitinib), or topical PDE4 inhibitors (crisaborole) for the treatment of AD within 1 week prior to the baseline visit.
Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
Treatment with chemotherapy or radiotherapy in the preceding 6 months.
Presence of skin comorbidities/concomitant conditions that may interfere with study assessments or interpretation of study results.
Planned or anticipated use of any prohibited medications.
History of malignancy except carcinoma in situ in the cervix, early-stage prostate cancer, or non-melanoma skin cancers.
Any disease, condition (medical or surgical), or cardiac abnormality that in the opinion of the Investigator would place the subject at increased risk.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations

COUNTRY
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United States

Participating Experts

Dr. Victoria Farley

Dermatologist

Dr. Lawrence C. C. Cheung

Dermatologist

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