Clinical trial NCT05155085: A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: AD
Dermatitis
Eczema
Lead sponsor: Allakos Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Proportion of Subjects Who Achieve 75% Improvement on the Eczema Area and Severity Index (EASI-75) at Week 14
timeFrame: Baseline to Week 14
Secondary outcomes:
measure: Percent Change in EASI From Baseline to Week 14
timeFrame: Baseline to Week 14
measure: Proportion of Subjects Achieving an IGA Score of 0 or 1 and a 2-point Improvement at Week 14 vs Baseline
timeFrame: Baseline to Week 14
Other outcomes:
measure: Safety and Tolerability of up to 7 Doses of Open-label AK002 in Subjects With Atopic Dermatitis in the Open-label Extension Period
timeFrame: Through study completion, up to 38 weeks (open-label extension period)
Locations:
city: Birmingham
country: United States
facility: Allakos Investigational Site 218-034
state: Alabama
city: Cullman
country: United States
facility: Allakos Investigational Site 218-074
state: Alabama
city: Gilbert
country: United States
facility: Allakos Investigational Site 218-025
state: Arizona
city: Scottsdale
country: United States
facility: Allakos Investigational Site 218-041
state: Arizona
city: Canoga Park
country: United States
facility: Allakos Investigational Site 218-072
state: California
city: Los Angeles
country: United States
facility: Allakos Investigational Site 218-056
state: California
city: San Diego
country: United States
facility: Allakos Investigational Site 218-073
state: California
city: San Francisco
country: United States
facility: Allakos Investigational Site 218-051
state: California
city: Santa Monica
country: United States
facility: Allakos Investigational Site 218-013
state: California
city: Santa Monica
country: United States
facility: Allakos Investigational Site 218-033
state: California
city: Colorado Springs
country: United States
facility: Allakos Investigational Site 218-071
state: Colorado
city: Washington
country: United States
facility: Allakos Investigational Site 218-045
state: District of Columbia
city: Doral
country: United States
facility: Allakos Investigational Site 218-018
state: Florida
city: Greenacres City
country: United States
facility: Allakos Investigational Site 218-046
state: Florida
city: Jacksonville
country: United States
facility: Allakos Investigational Site 218-049
state: Florida
city: Miami
country: United States
facility: Allakos Investigational Site 218-008
state: Florida
city: Sarasota
country: United States
facility: Allakos Investigational Site 218-048
state: Florida
city: Tampa
country: United States
facility: Allakos Investigational Site 218-020
state: Florida
city: Tampa
country: United States
facility: Allakos Investigational Site 218-007
state: Florida
city: Lexington
country: United States
facility: Allakos Investigational Site 218-068
state: Kentucky
city: Crowley
country: United States
facility: Allakos Investigational Site 218-055
state: Louisiana
city: Towson
country: United States
facility: Allakos Investigational Site 218-012
state: Maryland
city: White Marsh
country: United States
facility: Allakos Investigational Site 218-069
state: Maryland
city: Boston
country: United States
facility: Allakos Investigational Site 218-066
state: Massachusetts
city: Dilworth
country: United States
facility: Allakos Investigational Site 218-058
state: Minnesota
city: Missoula
country: United States
facility: Allakos Investigational Site 218-063
state: Montana
city: Omaha
country: United States
facility: Allakos Investigational Site 218-032
state: Nebraska
city: Las Vegas
country: United States
facility: Allakos Investigational Site 218-026
state: Nevada
city: Las Vegas
country: United States
facility: Allakos Investigational Site 218-050
state: Nevada
city: Great Neck
country: United States
facility: Allakos Investigational Site 218-029
state: New York
city: Rochester
country: United States
facility: Allakos Investigational Site 218-053
state: New York
city: Cincinnati
country: United States
facility: Allakos Investigational Site 218-001
state: Ohio
city: Fairborn
country: United States
facility: Allakos Investigational Site 218-062
state: Ohio
city: Oklahoma City
country: United States
facility: Allakos Investigational Site 218-003
state: Oklahoma
city: Oklahoma City
country: United States
facility: Allakos Investigational Site 218-015
state: Oklahoma
city: Portland
country: United States
facility: Allakos Investigational Site 218-061
state: Oregon
city: Philadelphia
country: United States
facility: Allakos Investigational Site 218-010
state: Pennsylvania
city: Dallas
country: United States
facility: Allakos Investigational Site 218-052
state: Texas
city: Murray
country: United States
facility: Allakos Investigational Site 218-047
state: Utah
city: Seattle
country: United States
facility: Allakos Investigational Site 218-009
state: Washington
city: Berlin
country: Germany
facility: Allakos Investigational Site 218-201
city: Darmstadt
country: Germany
facility: Allakos Investigational Site 218-215
city: Darmstadt
country: Germany
facility: Allakos Investigational Site 218-216
city: Dresden
country: Germany
facility: Allakos Investigational Site 218-208
city: Erlangen
country: Germany
facility: Allakos Investigational Site 218-207
city: Frankfurt am main
country: Germany
facility: Allakos Investigational Site 218-212
city: Gera
country: Germany
facility: Allakos Investigational Site 218-211
city: Lohne
country: Germany
facility: Allakos Investigational Site 218-203
city: Magdeburg
country: Germany
facility: Allakos Investigational Site 218-210
city: Mainz
country: Germany
facility: Allakos Investigational Site 218-204
city: Mainz
country: Germany
facility: Allakos Investigational Site 218-213
city: Munich
country: Germany
facility: Allakos Investigational Site 218-218
city: Osnabrück
country: Germany
facility: Allakos Investigational Site 218-205
city: Recklinghausen
country: Germany
facility: Allakos Investigational Site 218-202
city: Schwerin
country: Germany
facility: Allakos Investigational Site 218-209
Study officials:
affiliation: Allakos Inc.
name: Chin Lee, MD, MPH
role: STUDY_DIRECTOR
References: