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

• Sponsor: Allakos, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05155085
• Collaborator: (none)
• Enrollment: 130
• Locations: 48
• Arms: 2
• Anticipated Duration (Months): 8.1
• Patients Per Site: 2.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: AK002; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 27, 2022
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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
Other: Placebo Placebo	Other: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. The proportion of subjects who achieve 75% improvement on the Eczema Area and Severity Index (EASI-75) at Week 14 [Week 14]

Secondary Outcome Measures

1. Percent change in EASI from baseline to Week 14 [Baseline to Week 14]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allakos Investigational Site	Birmingham	Alabama	United States	35209
2	Allakos Investigational Site	Gilbert	Arizona	United States	85234
3	Allakos Investigational Site	Paradise Valley	Arizona	United States	85253
4	Allakos Investigational Site	Scottsdale	Arizona	United States	85251
5	Allakos Investigational Site	Yuma	Arizona	United States	85364
6	Allakos Investigational Site	Fountain Valley	California	United States	92708
7	Allakos Investigational Site	Fremont	California	United States	94538
8	Allakos Investigational Site	Rolling Hills	California	United States	90274
9	Allakos Investigational Site	Santa Monica	California	United States	90404
10	Allakos Investigational Site	Wheat Ridge	Colorado	United States	80033
11	Allakos Investigational Site	Shelton	Connecticut	United States	06484
12	Allakos Investigational Site	Shelton	Connecticut	United States	06484
13	Allakos Investigational Site	Brandon	Florida	United States	33511
14	Allakos Investigational Site	Doral	Florida	United States	33172
15	Allakos Investigational Site	Fort Lauderdale	Florida	United States	33308
16	Allakos Investigational Site	Greenacres City	Florida	United States	33467
17	Allakos Investigational Site	Jacksonville	Florida	United States	78758
18	Allakos Investigational Site	Miami	Florida	United States	33126
19	Allakos Investigational Site	Miami	Florida	United States	33134
20	Allakos Investigational Site	Sarasota	Florida	United States	34239
21	Allakos Investigational Site	Tampa	Florida	United States	33607
22	Allakos Investigational Site	Tampa	Florida	United States	33607
23	Allakos Investigational Site	Tampa	Florida	United States	33612
24	Allakos Investigational Site	Tampa	Florida	United States	33614
25	Allakos Investigational Site	Libertyville	Illinois	United States	60048
26	Allakos Investigational Site	Baltimore	Maryland	United States	21237
27	Allakos Investigational Site	Towson	Maryland	United States	21204
28	Allakos Investigational Site	Omaha	Nebraska	United States	68144
29	Allakos Investigational Site	Las Vegas	Nevada	United States	89030
30	Allakos Investigational Site	Las Vegas	Nevada	United States	89119
31	Allakos Investigational Site	Bronx	New York	United States	10455
32	Allakos Investigational Site	Great Neck	New York	United States	11021
33	Allakos Investigational Site	Charlotte	North Carolina	United States	28277
34	Allakos Investigational Site	Charlotte	North Carolina	United States	28777
35	Allakos Investigational Site	Beachwood	Ohio	United States	44122
36	Allakos Investigational Site	Cincinnati	Ohio	United States	45236
37	Allakos Investigational Site	Oklahoma City	Oklahoma	United States	73118
38	Allakos Investigational Site	Oklahoma City	Oklahoma	United States	73120
39	Allakos Investigational Site	Medford	Oregon	United States	97504
40	Allakos Investigational Site	Philadelphia	Pennsylvania	United States	19103
41	Allakos Investigational Site	Chattanooga	Tennessee	United States	37421
42	Allakos Investigational Site	San Antonio	Texas	United States	78213
43	Allakos Investigational Site	Murray	Utah	United States	84107
44	Allakos Investigational Site	Arlington	Virginia	United States	22209
45	Allakos Investigational Site	Richmond	Virginia	United States	23219
46	Allakos Investigational Site	Richmond	Virginia	United States	23233
47	Allakos Investigational Site	Seattle	Washington	United States	98115
48	Allakos Investigational Site	Seattle	Washington	United States	98119

Sponsors and Collaborators

• Allakos, Inc.

Investigators

• Study Director: Craig Paterson, MD, Allakos, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allakos, Inc.
• ClinicalTrials.gov Identifier: NCT05155085
• Other Study ID Numbers: AK002-018
• First Posted: Dec 13, 2021
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Allakos, Inc.: AD; Dermatitis; Eczema
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema

Study Results

No Results Posted as of Aug 22, 2022