Atopic DermatitisPhase 2ATLASNCT05155085
A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis
A Phase 2 study testing AK002 in people with Atopic Dermatitis, run by Allakos Inc. at 55 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- AK002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 55 sitesin 2 countries
- Study dates
- 27 Jun 2022to 17 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is able to understand the information on the study, has the capacity to consent, and has provided written informed consent.
- Male or female aged ≥18 and ≤80 years at the time of signing the informed consent form.
- 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.
- 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).
- 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.
- EASI score of ≥16 at screening and at baseline.
Show all 9Show fewer
- Involvement of at least 10% or more of BSA at screening and at baseline.
- An IGA score of 3 or above on a scale from 0-4 at screening and at baseline.
- 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.
Who cannot join
- Current use of biologics for any indication.
- 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).
- 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.
- 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.
- 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.
- Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
Show all 11Show fewer
- Treatment with chemotherapy or radiotherapy in the preceding 6 months.
- Presence of skin comorbidities/concomitant conditions that may interfere with study assessments or interpretation of study results.
- Planned or anticipated use of any prohibited medications.
- History of malignancy except carcinoma in situ in the cervix, early-stage prostate cancer, or non-melanoma skin cancers.
- Any disease, condition (medical or surgical), or cardiac abnormality that in the opinion of the Investigator would place the subject at increased risk.
Trial locations and contacts
55 sites in 2 countries.
55 sites in 2 countries
United States40 sites
Allakos Investigational Site 218-034
Birmingham, Alabama, 35209
Allakos Investigational Site 218-066
Boston, Massachusetts, 02111
Allakos Investigational Site 218-072
Canoga Park, California, 91303
Allakos Investigational Site 218-001
Cincinnati, Ohio, 45236
Allakos Investigational Site 218-071
Colorado Springs, Colorado, 80923
Allakos Investigational Site 218-055
Crowley, Louisiana, 70526
Allakos Investigational Site 218-074
Cullman, Alabama, 35058
Allakos Investigational Site 218-052
Dallas, Texas, 75230
Allakos Investigational Site 218-058
Dilworth, Minnesota, 56529
Allakos Investigational Site 218-018
Doral, Florida, 33172
Allakos Investigational Site 218-062
Fairborn, Ohio, 45324
Allakos Investigational Site 218-025
Gilbert, Arizona, 85018
Allakos Investigational Site 218-029
Great Neck, New York, 11021
Allakos Investigational Site 218-046
Greenacres City, Florida, 33467
Allakos Investigational Site 218-049
Jacksonville, Florida, 78758
Allakos Investigational Site 218-026
Las Vegas, Nevada, 89030
Allakos Investigational Site 218-050
Las Vegas, Nevada, 89119
Allakos Investigational Site 218-068
Lexington, Kentucky, 40509
Allakos Investigational Site 218-056
Los Angeles, California, 90057
Allakos Investigational Site 218-008
Miami, Florida, 33134
Allakos Investigational Site 218-063
Missoula, Montana, 59808
Allakos Investigational Site 218-047
Murray, Utah, 84107
Allakos Investigational Site 218-003
Oklahoma City, Oklahoma, 73118
Allakos Investigational Site 218-015
Oklahoma City, Oklahoma, 73120
Allakos Investigational Site 218-032
Omaha, Nebraska, 68144
Allakos Investigational Site 218-010
Philadelphia, Pennsylvania, 19103
Allakos Investigational Site 218-061
Portland, Oregon, 97210
Allakos Investigational Site 218-053
Rochester, New York, 14620
Allakos Investigational Site 218-073
San Diego, California, 92123
Allakos Investigational Site 218-051
San Francisco, California, 94132
Allakos Investigational Site 218-013
Santa Monica, California, 90404
Allakos Investigational Site 218-033
Santa Monica, California, 90404
Allakos Investigational Site 218-048
Sarasota, Florida, 34239
Allakos Investigational Site 218-041
Scottsdale, Arizona, 85258
Allakos Investigational Site 218-009
Seattle, Washington, 98115
Allakos Investigational Site 218-020
Tampa, Florida, 33607
Allakos Investigational Site 218-007
Tampa, Florida, 33614
Allakos Investigational Site 218-012
Towson, Maryland, 21204
Allakos Investigational Site 218-045
Washington D.C., District of Columbia, 20037
Allakos Investigational Site 218-069
White Marsh, Maryland, 21162
Germany15 sites
Allakos Investigational Site 218-201
Berlin, 12203
Allakos Investigational Site 218-215
Darmstadt, 64283
Allakos Investigational Site 218-216
Darmstadt, 64283
Allakos Investigational Site 218-208
Dresden, 01069
Allakos Investigational Site 218-207
Erlangen, 91054
Allakos Investigational Site 218-212
Frankfurt am Main, 60590
Allakos Investigational Site 218-211
Gera, 07548
Allakos Investigational Site 218-203
Löhne, 49393
Allakos Investigational Site 218-210
Magdeburg, 39104
Allakos Investigational Site 218-204
Mainz, 55128
Allakos Investigational Site 218-213
Mainz, 55131
Allakos Investigational Site 218-218
Munich, 81369
Allakos Investigational Site 218-205
Osnabrück, 49074
Allakos Investigational Site 218-202
Recklinghausen, 45657
Allakos Investigational Site 218-209
Schwerin, 19055
About this study
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
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.
- Conditions
- Atopic Dermatitis
- Being tested
- AK002, Placebo
- Keywords
- AD, Dermatitis, Eczema
- Medical subject headings
- Dermatitis, Atopic, Dermatitis, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK002Drug
Also called Lirentelimab
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Lirentelimab (AK002) SC 300 mg | Experimental | Subjects in this arm will receive 7 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks. Receives: Drug: AK002 |
| Placebo | Other | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to Week 14
Secondary outcomes (2)
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).
Measured: 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.
Measured: Baseline to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start27 Jun 2022
- Primary completion18 Dec 2023
- Study completion17 Apr 2024
Why it stopped: No longer pursuing development
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allakos Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chin Lee, MD, MPH, Study director, Allakos Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155085
- Sponsor's protocol ID
- AK002-018
- Acronym
- ATLAS
- Status last verified
- Sep 2024
- First submitted
- 1 Dec 2021
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05155085
- Acronym / sponsor ID
- ATLAS / AK002-018
- Conditions
- Atopic Dermatitis
- Keywords
- AD, Dermatitis, Eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No longer pursuing development
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Allakos Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Posted 24 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lirentelimab (AK002) SC 300 mg | Experimental | Drug: AK002Subjects in this arm will receive 7 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks. |
| Placebo | Other | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is able to understand the information on the study, has the capacity to consent, and has provided written informed consent.
- Male or female aged ≥18 and ≤80 years at the time of signing the informed consent form.
- 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.
- 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).
- 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.
Key exclusion criteria (11 listed)
- Current use of biologics for any indication.
- 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).
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK002Also: LirentelimabLirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8 | Drug | Lirentelimab (AK002) SC 300 mg |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
The Proportion of Subjects Who Achieve 75% Improvement on the Eczema Area and Severity Index (EASI-75) at Week 14
Time frame: 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).
2 secondary outcomes
Percent Change in EASI From Baseline to Week 14
Time frame: 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
Time frame: Baseline to Week 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin Lee, MD, MPH study director
Allakos Inc.
55 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK002 in people with Atopic Dermatitis, run by Allakos Inc. at 55 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Subjects Who Achieve 75% Improvement on the Eczema Area and Severity Index (EASI-75) at Week 14 (time frame: Baseline to Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.