Trial · NCT05528861
A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria
NCT05528861, Phase 2, Terminated, Allakos Inc.; results first posted 2024-09-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria. Trials, record NCT05528861. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05528861
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 Chronic Spontaneous Urticaria
- NCT number
- NCT05528861
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 127 participants, actual
- Lead sponsor
- Allakos Inc.
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- Lirentelimab (AK002), Placebo
- First posted
- 2022-09-06
- Last updated
- 2024-09-27
- Results first posted
- 2024-09-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change in Weekly Urticaria Assessment Score (UAS7) From Baseline at Week 12 | Baseline to Week 12 | The UAS7 is the sum for 7 days of the daily Hives Severity Score (HSS) and the daily Itch Severity Score (ISS). The daily HSS is recorded on a scale of 0 (none) to 3 (\>50 hives) and the daily ISS is recorded on a scale of 0 (none) to 3 (severe). Therefore, the possible range of the weekly UAS7 score is 0-42, with 42 being the most severe. |
| Secondary | Absolute Change in Hives Severity Score (HSS7) From Baseline at Week 12 | Baseline to Week 12 | The severity of hives will be recorded by all subjects once daily on a scale of 0 (none) to 3 (\> 50 hives). A weekly HSS score (HSS7) is derived by adding the average daily scores of the 7 days preceding the visit. Therefore, the possible range of the weekly score is 0 - 21. |
| Secondary | Absolute Change in Itch Severity Score (ISS7) From Baseline at Week 12 | Baseline to Week 12 | The severity of itching will be recorded by all subjects once daily on a scale of 0 (none) to 3 (severe). A weekly ISS score (ISS7) is derived by adding the average daily scores of the 7 days preceding the visit. Therefore, the possible range of the weekly score is 0 - 21. |
| Secondary | Proportion of Subjects Achieving Weekly Urticaria Assessment Score (UAS7)=0 at Week 12 | At Week 12 | The UAS7 is the sum for 7 days of the daily Hives Severity Score (HSS) and the daily Itch Severity Score (ISS). The possible range of the UAS7 is 0-42. |
| Other | Safety and Tolerability of up to 6 Doses of Open-label AK002 in Subjects With Chronic Spontaneous Urticaria in the Open-label Extension Period | Through study completion, up to 34 weeks (open-label extension period) | Adverse events were assessed throughout the open-label extension period. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change in Weekly Urticaria Assessment Score (UAS7) From Baseline at Week 12 | Baseline to Week 12 | Modified Intent-to-Treat Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in Hives Severity Score (HSS7) From Baseline at Week 12 | Baseline to Week 12 | Modified Intent-to-Treat Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in Itch Severity Score (ISS7) From Baseline at Week 12 | Baseline to Week 12 | Modified Intent-to-Treat Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Subjects Achieving Weekly Urticaria Assessment Score (UAS7)=0 at Week 12 | At Week 12 | Modified Intent-to-Treat Population | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Safety and Tolerability of up to 6 Doses of Open-label AK002 in Subjects With Chronic Spontaneous Urticaria in the Open-label Extension Period | Through study completion, up to 34 weeks (open-label extension period) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change in Weekly Urticaria Assessment Score (UAS7) From Baseline at Week 12 | AK002 SC 300 mg (Main Study) | -7.9 | Standard Error 1.9 | score on a scale | |
| Absolute Change in Weekly Urticaria Assessment Score (UAS7) From Baseline at Week 12 | Placebo (Main Study) | -8.4 | Standard Error 2.0 | score on a scale | |
| Absolute Change in Hives Severity Score (HSS7) From Baseline at Week 12 | AK002 SC 300 mg (Main Study) | -4.0 | Standard Error 0.8 | score on a scale | |
| Absolute Change in Hives Severity Score (HSS7) From Baseline at Week 12 | Placebo (Main Study) | -4.6 | Standard Error 0.9 | score on a scale | |
| Absolute Change in Itch Severity Score (ISS7) From Baseline at Week 12 | AK002 SC 300 mg (Main Study) | -4.4 | Standard Error 0.8 | score on a scale | |
| Absolute Change in Itch Severity Score (ISS7) From Baseline at Week 12 | Placebo (Main Study) | -4.3 | Standard Error 0.9 | score on a scale | |
| Proportion of Subjects Achieving Weekly Urticaria Assessment Score (UAS7)=0 at Week 12 | AK002 SC 300 mg (Main Study) | 6.3 | percentage of participants | ||
| Proportion of Subjects Achieving Weekly Urticaria Assessment Score (UAS7)=0 at Week 12 | Placebo (Main Study) | 0 | percentage of participants | ||
| Safety and Tolerability of up to 6 Doses of Open-label AK002 in Subjects With Chronic Spontaneous Urticaria in the Open-label Extension Period | AK002 Continuing (OLE) | Subjects with ≥1 adverse events | 31 | Participants | |
| Safety and Tolerability of up to 6 Doses of Open-label AK002 in Subjects With Chronic Spontaneous Urticaria in the Open-label Extension Period | Placebo Rollover (OLE) | Subjects with ≥1 adverse events | 26 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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) | 66 | |
| Main Study | STARTED | Placebo (Main Study) - Placebo Rollover (OLE) | 61 | |
| Main Study | COMPLETED | AK002 SC 300 mg (Main Study) - AK002 Continuing (OLE) | 60 | |
| Main Study | COMPLETED | Placebo (Main Study) - Placebo Rollover (OLE) | 57 | |
| Main Study | NOT COMPLETED | AK002 SC 300 mg (Main Study) - AK002 Continuing (OLE) | 6 | |
| Main Study | NOT COMPLETED | Placebo (Main Study) - Placebo Rollover (OLE) | 4 | |
| Open-Label Extension | STARTED | AK002 SC 300 mg (Main Study) - AK002 Continuing (OLE) | 60 | |
| Open-Label Extension | STARTED | Placebo (Main Study) - Placebo Rollover (OLE) | 57 | |
| Open-Label Extension | COMPLETED | AK002 SC 300 mg (Main Study) - AK002 Continuing (OLE) | 27 | |
| Open-Label Extension | COMPLETED | Placebo (Main Study) - Placebo Rollover (OLE) | 30 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events64
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 | Injection site reaction | General disorders | AK002 SC 300 mg (Main Study) | 14 | 66 | |
| other | Injection site reaction | General disorders | Placebo (Main Study) | 6 | 61 | |
| other | Injection site reaction | General disorders | AK002 Continuing (OLE) | 4 | 60 | |
| other | Injection site reaction | General disorders | Placebo Rollover (OLE) | 9 | 57 | |
| other | Nasopharyngitis | Infections and infestations | AK002 SC 300 mg (Main Study) | 6 | 66 | |
| other | Nasopharyngitis | Infections and infestations | Placebo (Main Study) | 3 | 61 | |
| other | Nasopharyngitis | Infections and infestations | AK002 Continuing (OLE) | 5 | 60 | |
| other | Nasopharyngitis | Infections and infestations | Placebo Rollover (OLE) | 1 | 57 | |
| other | Upper respiratory tract infection | Infections and infestations | AK002 SC 300 mg (Main Study) | 2 | 66 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo (Main Study) | 5 | 61 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 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 | 66 |
| Total, all-cause mortality | Placebo (Main Study) | 0 | 61 |
| Total, all-cause mortality | AK002 Continuing (OLE) | 0 | 60 |
| Total, all-cause mortality | Placebo Rollover (OLE) | 0 | 57 |
| Total, other adverse events | AK002 SC 300 mg (Main Study) | 26 | 66 |
| Total, other adverse events | Placebo (Main Study) | 18 | 61 |
| Total, other adverse events | AK002 Continuing (OLE) | 22 | 60 |
| Total, other adverse events | Placebo Rollover (OLE) | 19 | 57 |
| Total, serious adverse events | AK002 SC 300 mg (Main Study) | 1 | 66 |
| Total, serious adverse events | Placebo (Main Study) | 1 | 61 |
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/NCT05528861
GET https://conductscience.org/api/trials/v1/NCT05528861/events?page=2