Trial · NCT05155085
A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis
NCT05155085, Phase 2, Terminated, Allakos Inc.; results first posted 2024-09-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis. Trials, record NCT05155085. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05155085
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis
- NCT number
- NCT05155085
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 131 participants, actual
- Lead sponsor
- Allakos Inc.
- Conditions
- Atopic Dermatitis
- Interventions
- AK002, Placebo
- First posted
- 2021-12-13
- Last updated
- 2024-10-15
- Results first posted
- 2024-09-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Proportion of Subjects Who Achieve 75% Improvement on the Eczema Area and Severity Index (EASI-75) at Week 14 | 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). |
| Secondary | Percent Change in EASI From Baseline to Week 14 | 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). |
| Secondary | 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 | 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. |
| Other | Safety and Tolerability of up to 7 Doses of Open-label AK002 in Subjects With Atopic Dermatitis in the Open-label Extension Period | Through study completion, up to 38 weeks (open-label extension period) | Adverse events were assessed throughout the open-label extension period. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Proportion of Subjects Who Achieve 75% Improvement on the Eczema Area and Severity Index (EASI-75) at Week 14 | Baseline to Week 14 | Modified Intent-to-Treat Population | percentage of participants | NUMBER |
| SECONDARY | Percent Change in EASI From Baseline to Week 14 | Baseline to Week 14 | Modified Intent-to-Treat Population | Percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Modified Intent-to-Treat Population | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Safety and Tolerability of up to 7 Doses of Open-label AK002 in Subjects With Atopic Dermatitis in the Open-label Extension Period | Through study completion, up to 38 weeks (open-label extension period) | Safety population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Proportion of Subjects Who Achieve 75% Improvement on the Eczema Area and Severity Index (EASI-75) at Week 14 | AK002 SC 300 mg (Main Study) | 23.0 | percentage of participants | ||
| The Proportion of Subjects Who Achieve 75% Improvement on the Eczema Area and Severity Index (EASI-75) at Week 14 | Placebo (Main Study) | 18.0 | percentage of participants | ||
| Percent Change in EASI From Baseline to Week 14 | AK002 SC 300 mg (Main Study) | -36.0 | Standard Error 8.7 | Percentage of change | |
| Percent Change in EASI From Baseline to Week 14 | Placebo (Main Study) | -26.3 | Standard Error 8.7 | Percentage of change | |
| Proportion of Subjects Achieving an IGA Score of 0 or 1 and a 2-point Improvement at Week 14 vs Baseline | AK002 SC 300 mg (Main Study) | 11.5 | percentage of participants | ||
| Proportion of Subjects Achieving an IGA Score of 0 or 1 and a 2-point Improvement at Week 14 vs Baseline | Placebo (Main Study) | 8.2 | percentage of participants | ||
| Safety and Tolerability of up to 7 Doses of Open-label AK002 in Subjects With Atopic Dermatitis in the Open-label Extension Period | AK002 Continuing (OLE) | Subjects with ≥1 adverse events | 30 | Participants | |
| Safety and Tolerability of up to 7 Doses of Open-label AK002 in Subjects With Atopic Dermatitis in the Open-label Extension Period | Placebo Rollover (OLE) | Subjects with ≥1 adverse events | 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 | AK002 Continuing (OLE) | Subjects with ≥1 treatment-related adverse events | 3 | Participants | |
| Safety and Tolerability of up to 7 Doses of Open-label AK002 in Subjects With Atopic Dermatitis in the Open-label Extension Period | Placebo Rollover (OLE) | Subjects with ≥1 treatment-related adverse events | 13 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study | STARTED | AK002 SC 300 mg (Main Study) - AK002 Continuing (OLE) | 65 | |
| Main Study | STARTED | Placebo (Main Study) - Placebo Rollover (OLE) | 65 | |
| Main Study | COMPLETED | AK002 SC 300 mg (Main Study) - AK002 Continuing (OLE) | 57 | |
| Main Study | COMPLETED | Placebo (Main Study) - Placebo Rollover (OLE) | 58 | |
| Main Study | NOT COMPLETED | AK002 SC 300 mg (Main Study) - AK002 Continuing (OLE) | 8 | |
| Main Study | NOT COMPLETED | Placebo (Main Study) - Placebo Rollover (OLE) | 7 | |
| Open-Label Extension | STARTED | AK002 SC 300 mg (Main Study) - AK002 Continuing (OLE) | 55 | |
| Open-Label Extension | STARTED | Placebo (Main Study) - Placebo Rollover (OLE) | 57 | |
| Open-Label Extension | COMPLETED | AK002 SC 300 mg (Main Study) - AK002 Continuing (OLE) | 32 | |
| Open-Label Extension | COMPLETED | Placebo (Main Study) - Placebo Rollover (OLE) | 36 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | AK002 SC 300 mg (Main Study) | 3 | 65 | |
| other | Nasopharyngitis | Infections and infestations | Placebo (Main Study) | 4 | 65 | |
| other | Nasopharyngitis | Infections and infestations | AK002 Continuing (OLE) | 5 | 55 | |
| other | Nasopharyngitis | Infections and infestations | Placebo Rollover (OLE) | 4 | 57 | |
| other | Upper respiratory tract infection | Infections and infestations | AK002 SC 300 mg (Main Study) | 0 | 65 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo (Main Study) | 5 | 65 | |
| other | Upper respiratory tract infection | Infections and infestations | AK002 Continuing (OLE) | 2 | 55 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo Rollover (OLE) | 1 | 57 | |
| other | Injection related reaction | Injury, poisoning and procedural complications | AK002 SC 300 mg (Main Study) | 12 | 65 | |
| other | Injection related reaction | Injury, poisoning and procedural complications | Placebo (Main Study) | 4 | 65 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AK002 SC 300 mg (Main Study) | 0 | 65 |
| Total, all-cause mortality | Placebo (Main Study) | 0 | 65 |
| Total, all-cause mortality | AK002 Continuing (OLE) | 0 | 55 |
| Total, all-cause mortality | Placebo Rollover (OLE) | 0 | 57 |
| Total, other adverse events | AK002 SC 300 mg (Main Study) | 27 | 65 |
| Total, other adverse events | Placebo (Main Study) | 25 | 65 |
| Total, other adverse events | AK002 Continuing (OLE) | 15 | 55 |
| Total, other adverse events | Placebo Rollover (OLE) | 20 | 57 |
| Total, serious adverse events | AK002 SC 300 mg (Main Study) | 1 | 65 |
| Total, serious adverse events | Placebo (Main Study) | 3 | 65 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05155085
GET https://conductscience.org/api/trials/v1/NCT05155085/events?page=2