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

Allakos Inc.55 sites in 2 countries131 target enrollmentJune 27, 2022

ConditionsAtopic Dermatitis

InterventionsAK002 Placebo

Overview

Phase: Phase 2
Intervention: AK002
Conditions: Atopic Dermatitis
Sponsor: Allakos Inc.
Enrollment: 131
Locations: 55
Primary Endpoint: The Proportion of Subjects Who Achieve 75% Improvement on the Eczema Area and Severity Index (EASI-75) at Week 14
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 27, 2022

End Date

April 17, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Allakos Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

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.

Arms & Interventions

Lirentelimab (AK002) SC 300 mg

Subjects in this arm will receive 7 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks.

Intervention: AK002

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

The Proportion of Subjects Who Achieve 75% Improvement on the Eczema Area and Severity Index (EASI-75) at Week 14

Time Frame: Baseline to Week 14

The EASI score is a tool used to measure the extent (area) and severity of atopic dermatitis with respect to erythema, excoriation, induration, and lichenification over the 4 anatomic regions of the body: lower and upper extremities, trunk, and head. The total EASI score will be in a range from 0 to 72 points (from no disease to maximum disease severity).

Secondary Outcomes

Percent Change in EASI From Baseline to Week 14(Baseline to Week 14)
Proportion of Subjects Achieving an IGA Score of 0 or 1 and a 2-point Improvement at Week 14 vs Baseline(Baseline to Week 14)