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

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

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.

Study Overview

• Status: Terminated
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Placebo; Drug: AK002

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Allakos Investigational Site 218-201
  • Darmstadt, Germany, 64283
    • Allakos Investigational Site 218-215
  • Darmstadt, Germany, 64283
    • Allakos Investigational Site 218-216
  • Dresden, Germany, 01069
    • Allakos Investigational Site 218-208
  • Erlangen, Germany, 91054
    • Allakos Investigational Site 218-207
  • Frankfurt am main, Germany, 60590
    • Allakos Investigational Site 218-212
  • Gera, Germany, 07548
    • Allakos Investigational Site 218-211
  • Lohne, Germany, 49393
    • Allakos Investigational Site 218-203
  • Magdeburg, Germany, 39104
    • Allakos Investigational Site 218-210
  • Mainz, Germany, 55128
    • Allakos Investigational Site 218-204
  • Mainz, Germany, 55131
    • Allakos Investigational Site 218-213
  • Munich, Germany, 81369
    • Allakos Investigational Site 218-218
  • Osnabrück, Germany, 49074
    • Allakos Investigational Site 218-205
  • Recklinghausen, Germany, 45657
    • Allakos Investigational Site 218-202
  • Schwerin, Germany, 19055
    • Allakos Investigational Site 218-209
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Allakos Investigational Site 218-034
    • Cullman, Alabama, United States, 35058
      • Allakos Investigational Site 218-074
  • Arizona
    • Gilbert, Arizona, United States, 85018
      • Allakos Investigational Site 218-025
    • Scottsdale, Arizona, United States, 85258
      • Allakos Investigational Site 218-041
  • California
    • Canoga Park, California, United States, 91303
      • Allakos Investigational Site 218-072
    • Los Angeles, California, United States, 90057
      • Allakos Investigational Site 218-056
    • San Diego, California, United States, 92123
      • Allakos Investigational Site 218-073
    • San Francisco, California, United States, 94132
      • Allakos Investigational Site 218-051
    • Santa Monica, California, United States, 90404
      • Allakos Investigational Site 218-013
    • Santa Monica, California, United States, 90404
      • Allakos Investigational Site 218-033
  • Colorado
    • Colorado Springs, Colorado, United States, 80923
      • Allakos Investigational Site 218-071
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Allakos Investigational Site 218-045
  • Florida
    • Doral, Florida, United States, 33172
      • Allakos Investigational Site 218-018
    • Greenacres City, Florida, United States, 33467
      • Allakos Investigational Site 218-046
    • Jacksonville, Florida, United States, 78758
      • Allakos Investigational Site 218-049
    • Miami, Florida, United States, 33134
      • Allakos Investigational Site 218-008
    • Sarasota, Florida, United States, 34239
      • Allakos Investigational Site 218-048
    • Tampa, Florida, United States, 33607
      • Allakos Investigational Site 218-020
    • Tampa, Florida, United States, 33614
      • Allakos Investigational Site 218-007
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Allakos Investigational Site 218-068
  • Louisiana
    • Crowley, Louisiana, United States, 70526
      • Allakos Investigational Site 218-055
  • Maryland
    • Towson, Maryland, United States, 21204
      • Allakos Investigational Site 218-012
    • White Marsh, Maryland, United States, 21162
      • Allakos Investigational Site 218-069
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Allakos Investigational Site 218-066
  • Minnesota
    • Dilworth, Minnesota, United States, 56529
      • Allakos Investigational Site 218-058
  • Montana
    • Missoula, Montana, United States, 59808
      • Allakos Investigational Site 218-063
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Allakos Investigational Site 218-032
  • Nevada
    • Las Vegas, Nevada, United States, 89030
      • Allakos Investigational Site 218-026
    • Las Vegas, Nevada, United States, 89119
      • Allakos Investigational Site 218-050
  • New York
    • Great Neck, New York, United States, 11021
      • Allakos Investigational Site 218-029
    • Rochester, New York, United States, 14620
      • Allakos Investigational Site 218-053
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Allakos Investigational Site 218-001
    • Fairborn, Ohio, United States, 45324
      • Allakos Investigational Site 218-062
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Allakos Investigational Site 218-003
    • Oklahoma City, Oklahoma, United States, 73120
      • Allakos Investigational Site 218-015
  • Oregon
    • Portland, Oregon, United States, 97210
      • Allakos Investigational Site 218-061
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Allakos Investigational Site 218-010
  • Texas
    • Dallas, Texas, United States, 75230
      • Allakos Investigational Site 218-052
  • Utah
    • Murray, Utah, United States, 84107
      • Allakos Investigational Site 218-047
  • Washington
    • Seattle, Washington, United States, 98115
      • Allakos Investigational Site 218-009

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key 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.

Key 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Placebo	Other: Placebo; Placebo
Experimental: Lirentelimab (AK002) SC 300 mg; Subjects in this arm will receive 7 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks.	Drug: AK002; Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8; Other Names: Lirentelimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in EASI From 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).	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	The Investigator's Global Assessment (IGA) is a 5-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4 and assesses disease severity and clinical response using a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; and 4 = severe. The score is determined by ranking the extent of erythema and papulation/infiltration. A decrease in score relates to an improvement in signs and symptoms.	Baseline to Week 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of up to 7 Doses of Open-label AK002 in Subjects With Atopic Dermatitis in the Open-label Extension Period	Adverse events were assessed throughout the open-label extension period.	Through study completion, up to 38 weeks (open-label extension period)

Collaborators and Investigators

• Sponsor: Allakos Inc.
• Investigators: Study Director: Chin Lee, MD, MPH, Allakos Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2022
• Primary Completion (Actual): December 18, 2023
• Study Completion (Actual): April 17, 2024

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: AD; Eczema; Dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: AK002-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No