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

Phase 2

Terminated

• Conditions: Atopic Dermatitis
• Interventions: Drug: AK002; Other: Placebo

• Registration Number: NCT05155085
• Lead Sponsor: Allakos Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-13
• Study Start: 2022-06-27
• Primary Completion: 2023-12-18
• Study Completion: 2024-04-17
• Status Verified: 2024-09
• Results First Submitted: 2024-09-03
• Results First Submitted QC: 2024-09-03
• Results First Posted: 2024-09-24
• Last Update Submitted: 2024-09-24
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 131

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lirentelimab (AK002) SC 300 mg	AK002	Subjects in this arm will receive 7 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks.
Placebo	Placebo	Placebo

Primary Outcome Measures

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

Name	Time	Method
Percent Change in EASI From Baseline to Week 14	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).
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	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.

Trial Locations

Locations (55)

Allakos Investigational Site 218-029; 🇺🇸 Great Neck, New York, United States

Allakos Investigational Site 218-048; 🇺🇸 Sarasota, Florida, United States

Allakos Investigational Site 218-013; 🇺🇸 Santa Monica, California, United States

Allakos Investigational Site 218-052; 🇺🇸 Dallas, Texas, United States

Allakos Investigational Site 218-018; 🇺🇸 Doral, Florida, United States

Allakos Investigational Site 218-063; 🇺🇸 Missoula, Montana, United States

Allakos Investigational Site 218-008; 🇺🇸 Miami, Florida, United States

Allakos Investigational Site 218-041; 🇺🇸 Scottsdale, Arizona, United States

Allakos Investigational Site 218-032; 🇺🇸 Omaha, Nebraska, United States

Allakos Investigational Site 218-071; 🇺🇸 Colorado Springs, Colorado, United States

Allakos Investigational Site 218-207; 🇩🇪 Erlangen, Germany

Allakos Investigational Site 218-047; 🇺🇸 Murray, Utah, United States

Allakos Investigational Site 218-066; 🇺🇸 Boston, Massachusetts, United States

Allakos Investigational Site 218-055; 🇺🇸 Crowley, Louisiana, United States

Allakos Investigational Site 218-012; 🇺🇸 Towson, Maryland, United States

Allakos Investigational Site 218-062; 🇺🇸 Fairborn, Ohio, United States

Allakos Investigational Site 218-025; 🇺🇸 Gilbert, Arizona, United States

Allakos Investigational Site 218-020; 🇺🇸 Tampa, Florida, United States

Allakos Investigational Site 218-001; 🇺🇸 Cincinnati, Ohio, United States

Allakos Investigational Site 218-069; 🇺🇸 White Marsh, Maryland, United States

Allakos Investigational Site 218-046; 🇺🇸 Greenacres City, Florida, United States

Allakos Investigational Site 218-049; 🇺🇸 Jacksonville, Florida, United States

Allakos Investigational Site 218-058; 🇺🇸 Dilworth, Minnesota, United States

Allakos Investigational Site 218-201; 🇩🇪 Berlin, Germany

Allakos Investigational Site 218-033; 🇺🇸 Santa Monica, California, United States

Allakos Investigational Site 218-053; 🇺🇸 Rochester, New York, United States

Allakos Investigational Site 218-213; 🇩🇪 Mainz, Germany

Allakos Investigational Site 218-045; 🇺🇸 Washington, District of Columbia, United States

Allakos Investigational Site 218-215; 🇩🇪 Darmstadt, Germany

Allakos Investigational Site 218-216; 🇩🇪 Darmstadt, Germany

Allakos Investigational Site 218-009; 🇺🇸 Seattle, Washington, United States

Allakos Investigational Site 218-204; 🇩🇪 Mainz, Germany

Allakos Investigational Site 218-208; 🇩🇪 Dresden, Germany

Allakos Investigational Site 218-218; 🇩🇪 Munich, Germany

Allakos Investigational Site 218-212; 🇩🇪 Frankfurt am main, Germany

Allakos Investigational Site 218-203; 🇩🇪 Lohne, Germany

Allakos Investigational Site 218-211; 🇩🇪 Gera, Germany

Allakos Investigational Site 218-210; 🇩🇪 Magdeburg, Germany

Allakos Investigational Site 218-073; 🇺🇸 San Diego, California, United States

Allakos Investigational Site 218-051; 🇺🇸 San Francisco, California, 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 218-034; 🇺🇸 Birmingham, Alabama, 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 218-205; 🇩🇪 Osnabrück, Germany

Allakos Investigational Site 218-056; 🇺🇸 Los Angeles, California, United States

Allakos Investigational Site 218-074; 🇺🇸 Cullman, Alabama, United States

Allakos Investigational Site 218-072; 🇺🇸 Canoga Park, California, United States

Allakos Investigational Site 218-061; 🇺🇸 Portland, Oregon, United States

Allakos Investigational Site 218-010; 🇺🇸 Philadelphia, Pennsylvania, United States

Allakos Investigational Site 218-202; 🇩🇪 Recklinghausen, Germany

Allakos Investigational Site 218-209; 🇩🇪 Schwerin, Germany

Allakos Investigational Site 218-007; 🇺🇸 Tampa, Florida, United States

Allakos Investigational Site 218-068; 🇺🇸 Lexington, Kentucky, United States