Adults 18 to 80, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Proportion of Subjects Who Achieve 75% Improvement on the Eczema Area and Severity Index (EASI-75) at Week 14Primary· 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).
Group
Value
95% CI
AK002 SC 300 mg (Main Study)
23.0
Placebo (Main Study)
18.0
Percent Change in EASI From Baseline to Week 14Secondary· 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).
Group
Value
95% CI
AK002 SC 300 mg (Main Study)
-36.0
± 8.7
Placebo (Main Study)
-26.3
± 8.7
Proportion of Subjects Achieving an IGA Score of 0 or 1 and a 2-point Improvement at Week 14 vs BaselineSecondary· 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.
Group
Value
95% CI
AK002 SC 300 mg (Main Study)
11.5
Placebo (Main Study)
8.2
Safety and Tolerability of up to 7 Doses of Open-label AK002 in Subjects With Atopic Dermatitis in the Open-label Extension PeriodSecondary· Through study completion, up to 38 weeks (open-label extension period)
Adverse events were assessed throughout the open-label extension period.
Subjects with ≥1 adverse events
Group
Value
95% CI
AK002 Continuing (OLE)
30
Placebo Rollover (OLE)
31
Subjects with ≥1 treatment-related adverse events
Group
Value
95% CI
AK002 Continuing (OLE)
3
Placebo Rollover (OLE)
13
Subjects with an adverse event leading to study drug discontinuation
Group
Value
95% CI
AK002 Continuing (OLE)
2
Placebo Rollover (OLE)
1
Subjects with ≥1 serious adverse events
Group
Value
95% CI
AK002 Continuing (OLE)
2
Placebo Rollover (OLE)
0
Subjects with ≥1 treatment-related serious adverse events
Group
Value
95% CI
AK002 Continuing (OLE)
0
Placebo Rollover (OLE)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Through study completion, up to 38 weeks (open-label extension period).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04856891 — A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis
· Phase 3
· completed
NCT03664960 — An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis
· Phase 2
· completed
NCT03496571 — A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis
· Phase 2
· completed
NCT03379311 — A Study of AK002 in Patients With Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic Conju
· Phase 1
· completed
NCT03436797 — A Study to Assess the Efficacy and Safety of AK002 in Subjects With Antihistamine-Resistant Chronic Urticaria
· Phase 2
· completed
Other recruiting trials for Atopic Dermatitis
Currently open trials in the same condition.
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· recruiting
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NCT07488065 — A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants
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· recruiting
NCT07467564 — The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatit
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Other Allakos Inc. trials
Trials by the same sponsor.
NCT06577116 — Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study
· Phase 1
· completed
NCT06072157 — Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects
· Phase 1
· completed
NCT05528861 — A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria
· Phase 2
· terminated
NCT04856891 — A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis
· Phase 3
· completed
NCT04620811 — An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eos
· Phase 3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allakos Inc.
Last refreshed: 15 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05155085.