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

Atopic Dermatitis Clinical Trial

— ATLAS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05155085
• Other study ID #: AK002-018
• Status: Terminated
• Phase: Phase 2
• Start date: June 27, 2022
• Est. completion date: April 17, 2024

Study information

• Verified date: June 2024
• Source: Allakos Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 131
• Est. completion date: April 17, 2024
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	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	Lohne
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
United States	Allakos Investigational Site 218-034	Birmingham	Alabama
United States	Allakos Investigational Site 218-066	Boston	Massachusetts
United States	Allakos Investigational Site 218-072	Canoga Park	California
United States	Allakos Investigational Site 218-001	Cincinnati	Ohio
United States	Allakos Investigational Site 218-071	Colorado Springs	Colorado
United States	Allakos Investigational Site 218-055	Crowley	Louisiana
United States	Allakos Investigational Site 218-074	Cullman	Alabama
United States	Allakos Investigational Site 218-052	Dallas	Texas
United States	Allakos Investigational Site 218-058	Dilworth	Minnesota
United States	Allakos Investigational Site 218-018	Doral	Florida
United States	Allakos Investigational Site 218-062	Fairborn	Ohio
United States	Allakos Investigational Site 218-025	Gilbert	Arizona
United States	Allakos Investigational Site 218-029	Great Neck	New York
United States	Allakos Investigational Site 218-046	Greenacres City	Florida
United States	Allakos Investigational Site 218-049	Jacksonville	Florida
United States	Allakos Investigational Site 218-026	Las Vegas	Nevada
United States	Allakos Investigational Site 218-050	Las Vegas	Nevada
United States	Allakos Investigational Site 218-068	Lexington	Kentucky
United States	Allakos Investigational Site 218-056	Los Angeles	California
United States	Allakos Investigational Site 218-008	Miami	Florida
United States	Allakos Investigational Site 218-063	Missoula	Montana
United States	Allakos Investigational Site 218-047	Murray	Utah
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 218-032	Omaha	Nebraska
United States	Allakos Investigational Site 218-010	Philadelphia	Pennsylvania
United States	Allakos Investigational Site 218-061	Portland	Oregon
United States	Allakos Investigational Site 218-053	Rochester	New York
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 218-048	Sarasota	Florida
United States	Allakos Investigational Site 218-041	Scottsdale	Arizona
United States	Allakos Investigational Site 218-009	Seattle	Washington
United States	Allakos Investigational Site 218-007	Tampa	Florida
United States	Allakos Investigational Site 218-020	Tampa	Florida
United States	Allakos Investigational Site 218-012	Towson	Maryland
United States	Allakos Investigational Site 218-045	Washington	District of Columbia
United States	Allakos Investigational Site 218-069	White Marsh	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Allakos Inc.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects who achieve 75% improvement on the Eczema Area and Severity Index (EASI-75) at Week 14		Week 14
Secondary	Percent change in EASI from baseline to Week 14		Baseline to Week 14
Secondary	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