Trial Outcomes & Findings for A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis (NCT NCT05155085)
NCT ID: NCT05155085
Last Updated: 2024-10-15
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
Baseline to Week 14
Results posted on
2024-10-15
Participant Flow
130 subjects who were enrolled in the main study received up to 7 doses of AK002 or placebo. 112 subjects from the main study continued into the open-label extension (OLE) period and received up to 7 doses of AK002.
Participant milestones
| Measure |
AK002 SC 300 mg (Main Study) - AK002 Continuing (OLE)
For the main study period, subjects in this arm received up to 7 doses of 300 mg of lirentelimab (AK002) administered subcutaneously (SC) every 2 weeks.
For the open-label extension (OLE) period, subjects who completed the main study and met eligibility criteria had the option to receive 7 doses of 300 mg AK002 SC.
AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8
|
Placebo (Main Study) - Placebo Rollover (OLE)
For the main study period, subjects in this arm received up to 7 doses of placebo administered subcutaneously every 2 weeks.
For the open-label extension (OLE) period, subjects who completed the main study and met the eligibility criteria had the option to rollover and receive 7 doses of 300 mg AK002 SC.
Placebo: Placebo
AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8
|
|---|---|---|
|
Main Study
STARTED
|
65
|
65
|
|
Main Study
COMPLETED
|
57
|
58
|
|
Main Study
NOT COMPLETED
|
8
|
7
|
|
Open-Label Extension
STARTED
|
55
|
57
|
|
Open-Label Extension
COMPLETED
|
32
|
36
|
|
Open-Label Extension
NOT COMPLETED
|
23
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
AK002 SC 300 mg (Main Study)
n=65 Participants
Subjects in this arm received up to 7 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks.
AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8
|
Placebo (Main Study)
n=65 Participants
Subjects in this arm received up to 7 doses of placebo administered subcutaneously every 2 weeks.
Placebo: Placebo
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 years
n=5 Participants
|
35 years
n=7 Participants
|
38 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Eczema Area and Severity Index (EASI) Score
|
28.1 Score on a scale
STANDARD_DEVIATION 7.5 • n=5 Participants
|
30.1 Score on a scale
STANDARD_DEVIATION 10.7 • n=7 Participants
|
29.1 Score on a scale
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Investigator's Global Assessment (IGA) Score
|
3 Score on a scale
STANDARD_DEVIATION 1 • n=5 Participants
|
3 Score on a scale
STANDARD_DEVIATION 1 • n=7 Participants
|
3 Score on a scale
STANDARD_DEVIATION 1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 14Population: Modified Intent-to-Treat Population
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).
Outcome measures
| Measure |
AK002 SC 300 mg (Main Study)
n=61 Participants
Subjects in this arm received up to 7 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks in the main study.
AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8
|
Placebo (Main Study)
n=61 Participants
Subjects in this arm received up to 7 doses of placebo administered subcutaneously every 2 weeks in the main study.
Placebo: Placebo
|
|---|---|---|
|
The Proportion of Subjects Who Achieve 75% Improvement on the Eczema Area and Severity Index (EASI-75) at Week 14
|
23.0 percentage of participants
|
18.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 14Population: Modified Intent-to-Treat Population
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).
Outcome measures
| Measure |
AK002 SC 300 mg (Main Study)
n=61 Participants
Subjects in this arm received up to 7 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks in the main study.
AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8
|
Placebo (Main Study)
n=61 Participants
Subjects in this arm received up to 7 doses of placebo administered subcutaneously every 2 weeks in the main study.
Placebo: Placebo
|
|---|---|---|
|
Percent Change in EASI From Baseline to Week 14
|
-36.0 Percentage of change
Standard Error 8.7
|
-26.3 Percentage of change
Standard Error 8.7
|
SECONDARY outcome
Timeframe: Baseline to Week 14Population: Modified Intent-to-Treat Population
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.
Outcome measures
| Measure |
AK002 SC 300 mg (Main Study)
n=61 Participants
Subjects in this arm received up to 7 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks in the main study.
AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8
|
Placebo (Main Study)
n=61 Participants
Subjects in this arm received up to 7 doses of placebo administered subcutaneously every 2 weeks in the main study.
Placebo: Placebo
|
|---|---|---|
|
Proportion of Subjects Achieving an IGA Score of 0 or 1 and a 2-point Improvement at Week 14 vs Baseline
|
11.5 percentage of participants
|
8.2 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, up to 38 weeks (open-label extension period)Population: Safety population
Adverse events were assessed throughout the open-label extension period.
Outcome measures
| Measure |
AK002 SC 300 mg (Main Study)
n=55 Participants
Subjects in this arm received up to 7 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks in the main study.
AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8
|
Placebo (Main Study)
n=57 Participants
Subjects in this arm received up to 7 doses of placebo administered subcutaneously every 2 weeks in the main study.
Placebo: Placebo
|
|---|---|---|
|
Safety and Tolerability of up to 7 Doses of Open-label AK002 in Subjects With Atopic Dermatitis in the Open-label Extension Period
Subjects with ≥1 adverse events
|
30 Participants
|
31 Participants
|
|
Safety and Tolerability of up to 7 Doses of Open-label AK002 in Subjects With Atopic Dermatitis in the Open-label Extension Period
Subjects with ≥1 treatment-related adverse events
|
3 Participants
|
13 Participants
|
|
Safety and Tolerability of up to 7 Doses of Open-label AK002 in Subjects With Atopic Dermatitis in the Open-label Extension Period
Subjects with an adverse event leading to study drug discontinuation
|
2 Participants
|
1 Participants
|
|
Safety and Tolerability of up to 7 Doses of Open-label AK002 in Subjects With Atopic Dermatitis in the Open-label Extension Period
Subjects with ≥1 serious adverse events
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of up to 7 Doses of Open-label AK002 in Subjects With Atopic Dermatitis in the Open-label Extension Period
Subjects with ≥1 treatment-related serious adverse events
|
0 Participants
|
0 Participants
|
Adverse Events
AK002 SC 300 mg (Main Study)
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo (Main Study)
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
AK002 Continuing (OLE)
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo Rollover (OLE)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AK002 SC 300 mg (Main Study)
n=65 participants at risk
Subjects in this arm received up to 7 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks.
AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8
|
Placebo (Main Study)
n=65 participants at risk
Subjects in this arm received up to 7 doses of placebo administered subcutaneously every 2 weeks.
Placebo: Placebo
|
AK002 Continuing (OLE)
n=55 participants at risk
Subjects in this arm received AK002 in the main study and continued to receive up to 7 doses of 300 mg AK002 SC in the open-label extension (OLE) period.
AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8
|
Placebo Rollover (OLE)
n=57 participants at risk
Subjects in this arm received placebo in the main study and rolled over to receive up to 7 doses of 300 mg AK002 SC in the open-label extension (OLE) period.
Placebo: Placebo
AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8
|
|---|---|---|---|---|
|
Infections and infestations
Eczema herpeticum
|
1.5%
1/65 • Through study completion, up to 38 weeks (open-label extension period)
|
0.00%
0/65 • Through study completion, up to 38 weeks (open-label extension period)
|
0.00%
0/55 • Through study completion, up to 38 weeks (open-label extension period)
|
0.00%
0/57 • Through study completion, up to 38 weeks (open-label extension period)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/65 • Through study completion, up to 38 weeks (open-label extension period)
|
3.1%
2/65 • Through study completion, up to 38 weeks (open-label extension period)
|
0.00%
0/55 • Through study completion, up to 38 weeks (open-label extension period)
|
0.00%
0/57 • Through study completion, up to 38 weeks (open-label extension period)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/65 • Through study completion, up to 38 weeks (open-label extension period)
|
1.5%
1/65 • Through study completion, up to 38 weeks (open-label extension period)
|
0.00%
0/55 • Through study completion, up to 38 weeks (open-label extension period)
|
0.00%
0/57 • Through study completion, up to 38 weeks (open-label extension period)
|
|
General disorders
Chest pain
|
0.00%
0/65 • Through study completion, up to 38 weeks (open-label extension period)
|
0.00%
0/65 • Through study completion, up to 38 weeks (open-label extension period)
|
1.8%
1/55 • Through study completion, up to 38 weeks (open-label extension period)
|
0.00%
0/57 • Through study completion, up to 38 weeks (open-label extension period)
|
|
Infections and infestations
Appendicitis
|
0.00%
0/65 • Through study completion, up to 38 weeks (open-label extension period)
|
0.00%
0/65 • Through study completion, up to 38 weeks (open-label extension period)
|
1.8%
1/55 • Through study completion, up to 38 weeks (open-label extension period)
|
0.00%
0/57 • Through study completion, up to 38 weeks (open-label extension period)
|
Other adverse events
| Measure |
AK002 SC 300 mg (Main Study)
n=65 participants at risk
Subjects in this arm received up to 7 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks.
AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8
|
Placebo (Main Study)
n=65 participants at risk
Subjects in this arm received up to 7 doses of placebo administered subcutaneously every 2 weeks.
Placebo: Placebo
|
AK002 Continuing (OLE)
n=55 participants at risk
Subjects in this arm received AK002 in the main study and continued to receive up to 7 doses of 300 mg AK002 SC in the open-label extension (OLE) period.
AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8
|
Placebo Rollover (OLE)
n=57 participants at risk
Subjects in this arm received placebo in the main study and rolled over to receive up to 7 doses of 300 mg AK002 SC in the open-label extension (OLE) period.
Placebo: Placebo
AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1)monoclonal antibody directed against Siglec-8
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.6%
3/65 • Through study completion, up to 38 weeks (open-label extension period)
|
6.2%
4/65 • Through study completion, up to 38 weeks (open-label extension period)
|
9.1%
5/55 • Through study completion, up to 38 weeks (open-label extension period)
|
7.0%
4/57 • Through study completion, up to 38 weeks (open-label extension period)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/65 • Through study completion, up to 38 weeks (open-label extension period)
|
7.7%
5/65 • Through study completion, up to 38 weeks (open-label extension period)
|
3.6%
2/55 • Through study completion, up to 38 weeks (open-label extension period)
|
1.8%
1/57 • Through study completion, up to 38 weeks (open-label extension period)
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
18.5%
12/65 • Through study completion, up to 38 weeks (open-label extension period)
|
6.2%
4/65 • Through study completion, up to 38 weeks (open-label extension period)
|
0.00%
0/55 • Through study completion, up to 38 weeks (open-label extension period)
|
15.8%
9/57 • Through study completion, up to 38 weeks (open-label extension period)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/65 • Through study completion, up to 38 weeks (open-label extension period)
|
7.7%
5/65 • Through study completion, up to 38 weeks (open-label extension period)
|
1.8%
1/55 • Through study completion, up to 38 weeks (open-label extension period)
|
1.8%
1/57 • Through study completion, up to 38 weeks (open-label extension period)
|
|
Nervous system disorders
Headache
|
7.7%
5/65 • Through study completion, up to 38 weeks (open-label extension period)
|
9.2%
6/65 • Through study completion, up to 38 weeks (open-label extension period)
|
5.5%
3/55 • Through study completion, up to 38 weeks (open-label extension period)
|
5.3%
3/57 • Through study completion, up to 38 weeks (open-label extension period)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
16.9%
11/65 • Through study completion, up to 38 weeks (open-label extension period)
|
13.8%
9/65 • Through study completion, up to 38 weeks (open-label extension period)
|
10.9%
6/55 • Through study completion, up to 38 weeks (open-label extension period)
|
1.8%
1/57 • Through study completion, up to 38 weeks (open-label extension period)
|
|
General disorders
Injection site reaction
|
1.5%
1/65 • Through study completion, up to 38 weeks (open-label extension period)
|
1.5%
1/65 • Through study completion, up to 38 weeks (open-label extension period)
|
0.00%
0/55 • Through study completion, up to 38 weeks (open-label extension period)
|
10.5%
6/57 • Through study completion, up to 38 weeks (open-label extension period)
|
|
Infections and infestations
Influenza
|
0.00%
0/65 • Through study completion, up to 38 weeks (open-label extension period)
|
0.00%
0/65 • Through study completion, up to 38 weeks (open-label extension period)
|
1.8%
1/55 • Through study completion, up to 38 weeks (open-label extension period)
|
5.3%
3/57 • Through study completion, up to 38 weeks (open-label extension period)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/65 • Through study completion, up to 38 weeks (open-label extension period)
|
4.6%
3/65 • Through study completion, up to 38 weeks (open-label extension period)
|
0.00%
0/55 • Through study completion, up to 38 weeks (open-label extension period)
|
5.3%
3/57 • Through study completion, up to 38 weeks (open-label extension period)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Trial Agreement contains a limit on publication of results following completion of the trial. PIs are not allowed to publish results until a joint publication for the multicenter study or a set period of time. After that time, PIs may only publish results from their portion of the study.
- Publication restrictions are in place
Restriction type: OTHER