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

NCT05155085 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: AK002-018
• Study Type: interventional
• Target: 131
• Locations: 2 countries
• Sites: 55

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

Keywords

AD; Dermatitis; Eczema

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Week 14

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Safety and Tolerability of up to 7 Doses of Open-label AK002 in Subjects With Atopic Dermatitis in the Open-label Extension Period

  Through study completion, up to 38 weeks (open-label extension period)

Study Arms (2)

Lirentelimab (AK002) SC 300 mg

EXPERIMENTAL

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

Drug: AK002

Placebo

OTHER

Placebo

Other: Placebo

Interventions

AK002 DRUG

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

Also known as: Lirentelimab

Lirentelimab (AK002) SC 300 mg

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allakos Inc.: lead

Study Sites (55)

Allakos Investigational Site 218-034

Birmingham, Alabama, 35209, United States

Location

Allakos Investigational Site 218-074

Cullman, Alabama, 35058, United States

Location

Allakos Investigational Site 218-025

Gilbert, Arizona, 85018, United States

Location

Allakos Investigational Site 218-041

Scottsdale, Arizona, 85258, United States

Location

Allakos Investigational Site 218-072

Canoga Park, California, 91303, United States

Location

Allakos Investigational Site 218-056

Los Angeles, California, 90057, United States

Location

Allakos Investigational Site 218-073

San Diego, California, 92123, United States

Location

Allakos Investigational Site 218-051

San Francisco, California, 94132, United States

Location

Allakos Investigational Site 218-013

Santa Monica, California, 90404, United States

Location

Allakos Investigational Site 218-033

Santa Monica, California, 90404, United States

Location

Allakos Investigational Site 218-071

Colorado Springs, Colorado, 80923, United States

Location

Allakos Investigational Site 218-045

Washington D.C., District of Columbia, 20037, United States

Location

Allakos Investigational Site 218-018

Doral, Florida, 33172, United States

Location

Allakos Investigational Site 218-046

Greenacres City, Florida, 33467, United States

Location

Allakos Investigational Site 218-049

Jacksonville, Florida, 78758, United States

Location

Allakos Investigational Site 218-008

Miami, Florida, 33134, United States

Location

Allakos Investigational Site 218-048

Sarasota, Florida, 34239, United States

Location

Allakos Investigational Site 218-020

Tampa, Florida, 33607, United States

Location

Allakos Investigational Site 218-007

Tampa, Florida, 33614, United States

Location

Allakos Investigational Site 218-068

Lexington, Kentucky, 40509, United States

Location

Allakos Investigational Site 218-055

Crowley, Louisiana, 70526, United States

Location

Allakos Investigational Site 218-012

Towson, Maryland, 21204, United States

Location

Allakos Investigational Site 218-069

White Marsh, Maryland, 21162, United States

Location

Allakos Investigational Site 218-066

Boston, Massachusetts, 02111, United States

Location

Allakos Investigational Site 218-058

Dilworth, Minnesota, 56529, United States

Location

Allakos Investigational Site 218-063

Missoula, Montana, 59808, United States

Location

Allakos Investigational Site 218-032

Omaha, Nebraska, 68144, United States

Location

Allakos Investigational Site 218-026

Las Vegas, Nevada, 89030, United States

Location

Allakos Investigational Site 218-050

Las Vegas, Nevada, 89119, United States

Location

Allakos Investigational Site 218-029

Great Neck, New York, 11021, United States

Location

Allakos Investigational Site 218-053

Rochester, New York, 14620, United States

Location

Allakos Investigational Site 218-001

Cincinnati, Ohio, 45236, United States

Location

Allakos Investigational Site 218-062

Fairborn, Ohio, 45324, United States

Location

Allakos Investigational Site 218-003

Oklahoma City, Oklahoma, 73118, United States

Location

Allakos Investigational Site 218-015

Oklahoma City, Oklahoma, 73120, United States

Location

Allakos Investigational Site 218-061

Portland, Oregon, 97210, United States

Location

Allakos Investigational Site 218-010

Philadelphia, Pennsylvania, 19103, United States

Location

Allakos Investigational Site 218-052

Dallas, Texas, 75230, United States

Location

Allakos Investigational Site 218-047

Murray, Utah, 84107, United States

Location

Allakos Investigational Site 218-009

Seattle, Washington, 98115, United States

Location

Allakos Investigational Site 218-201

Berlin, 12203, Germany

Location

Allakos Investigational Site 218-215

Darmstadt, 64283, Germany

Location

Allakos Investigational Site 218-216

Darmstadt, 64283, Germany

Location

Allakos Investigational Site 218-208

Dresden, 01069, Germany

Location

Allakos Investigational Site 218-207

Erlangen, 91054, Germany

Location

Allakos Investigational Site 218-212

Frankfurt am Main, 60590, Germany

Location

Allakos Investigational Site 218-211

Gera, 07548, Germany

Location

Allakos Investigational Site 218-203

Löhne, 49393, Germany

Location

Allakos Investigational Site 218-210

Magdeburg, 39104, Germany

Location

Allakos Investigational Site 218-204

Mainz, 55128, Germany

Location

Allakos Investigational Site 218-213

Mainz, 55131, Germany

Location

Allakos Investigational Site 218-218

Munich, 81369, Germany

Location

Allakos Investigational Site 218-205

Osnabrück, 49074, Germany

Location

Allakos Investigational Site 218-202

Recklinghausen, 45657, Germany

Location

Allakos Investigational Site 218-209

Schwerin, 19055, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis; Eczema

Interventions

AK002

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Medical Information
• Organization: Allakos

medinfo@allakos.com

650-597-5002

Study Officials

• Chin Lee, MD, MPH

  Allakos Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 13, 2021
• Study Start: June 27, 2022
• Primary Completion: December 18, 2023
• Study Completion: April 17, 2024
• Last Updated: October 15, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (40); DE (15)