A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis

NCT ID: NCT05155085

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-27
• Study Completion Date: 2024-04-17

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lirentelimab (AK002) SC 300 mg

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

Group Type: EXPERIMENTAL

AK002

Intervention Type: DRUG

Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8

Placebo

Placebo

Group Type: OTHER

Placebo

Intervention Type: OTHER

Placebo

Interventions

AK002

Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: OTHER

Other Intervention Names

Lirentelimab

Eligibility Criteria

Inclusion Criteria

1. Subject is able to understand the information on the study, has the capacity to consent, and has provided written informed consent.

2. Male or female aged ≥18 and ≤80 years at the time of signing the informed consent form.

3. 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.

4. 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).

5. 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.

6. EASI score of ≥16 at screening and at baseline.

7. Involvement of at least 10% or more of BSA at screening and at baseline.

8. An IGA score of 3 or above on a scale from 0-4 at screening and at baseline.

9. 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

1. Current use of biologics for any indication.

2. 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).

3. 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.

4. 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.

5. 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.

6. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.

7. Treatment with chemotherapy or radiotherapy in the preceding 6 months.

8. Presence of skin comorbidities/concomitant conditions that may interfere with study assessments or interpretation of study results.

9. Planned or anticipated use of any prohibited medications.

10. History of malignancy except carcinoma in situ in the cervix, early-stage prostate cancer, or non-melanoma skin cancers.

11. Any disease, condition (medical or surgical), or cardiac abnormality that in the opinion of the Investigator would place the subject at increased risk.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allakos Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chin Lee, MD, MPH

Role: STUDY_DIRECTOR

Allakos Inc.

Locations

Allakos Investigational Site 218-034

Birmingham, Alabama, United States

Allakos Investigational Site 218-074

Cullman, Alabama, United States

Allakos Investigational Site 218-025

Gilbert, Arizona, United States

Allakos Investigational Site 218-041

Scottsdale, Arizona, United States

Allakos Investigational Site 218-072

Canoga Park, California, United States

Allakos Investigational Site 218-056

Los Angeles, California, United States

Allakos Investigational Site 218-073

San Diego, California, United States

Allakos Investigational Site 218-051

San Francisco, California, United States

Allakos Investigational Site 218-013

Santa Monica, California, United States

Allakos Investigational Site 218-033

Santa Monica, California, United States

Allakos Investigational Site 218-071

Colorado Springs, Colorado, United States

Allakos Investigational Site 218-045

Washington D.C., District of Columbia, United States

Allakos Investigational Site 218-018

Doral, Florida, United States

Allakos Investigational Site 218-046

Greenacres City, Florida, United States

Allakos Investigational Site 218-049

Jacksonville, Florida, United States

Allakos Investigational Site 218-008

Miami, Florida, United States

Allakos Investigational Site 218-048

Sarasota, Florida, United States

Allakos Investigational Site 218-020

Tampa, Florida, United States

Allakos Investigational Site 218-007

Tampa, Florida, United States

Allakos Investigational Site 218-068

Lexington, Kentucky, United States

Allakos Investigational Site 218-055

Crowley, Louisiana, United States

Allakos Investigational Site 218-012

Towson, Maryland, United States

Allakos Investigational Site 218-069

White Marsh, Maryland, United States

Allakos Investigational Site 218-066

Boston, Massachusetts, United States

Allakos Investigational Site 218-058

Dilworth, Minnesota, United States

Allakos Investigational Site 218-063

Missoula, Montana, United States

Allakos Investigational Site 218-032

Omaha, Nebraska, United States

Allakos Investigational Site 218-026

Las Vegas, Nevada, United States

Allakos Investigational Site 218-050

Las Vegas, Nevada, United States

Allakos Investigational Site 218-029

Great Neck, New York, United States

Allakos Investigational Site 218-053

Rochester, New York, United States

Allakos Investigational Site 218-001

Cincinnati, Ohio, United States

Allakos Investigational Site 218-062

Fairborn, Ohio, United States

Allakos Investigational Site 218-003

Oklahoma City, Oklahoma, United States

Allakos Investigational Site 218-015

Oklahoma City, Oklahoma, United States

Allakos Investigational Site 218-061

Portland, Oregon, United States

Allakos Investigational Site 218-010

Philadelphia, Pennsylvania, United States

Allakos Investigational Site 218-052

Dallas, Texas, United States

Allakos Investigational Site 218-047

Murray, Utah, United States

Allakos Investigational Site 218-009

Seattle, Washington, United States

Allakos Investigational Site 218-201

Berlin, , Germany

Allakos Investigational Site 218-215

Darmstadt, , Germany

Allakos Investigational Site 218-216

Darmstadt, , Germany

Allakos Investigational Site 218-208

Dresden, , Germany

Allakos Investigational Site 218-207

Erlangen, , Germany

Allakos Investigational Site 218-212

Frankfurt am Main, , Germany

Allakos Investigational Site 218-211

Gera, , Germany

Allakos Investigational Site 218-203

Löhne, , Germany

Allakos Investigational Site 218-210

Magdeburg, , Germany

Allakos Investigational Site 218-204

Mainz, , Germany

Allakos Investigational Site 218-213

Mainz, , Germany

Allakos Investigational Site 218-218

Munich, , Germany

Allakos Investigational Site 218-205

Osnabrück, , Germany

Allakos Investigational Site 218-202

Recklinghausen, , Germany

Allakos Investigational Site 218-209

Schwerin, , Germany

Countries

United States; Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AK002-018

Identifier Type: -

Identifier Source: org_study_id