Trial · NCT05352893
Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
NCT05352893, Phase 3, Completed, Vanda Pharmaceuticals; results first posted 2026-03-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP. Trials, record NCT05352893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05352893
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
- NCT number
- NCT05352893
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 45 participants, actual
- Lead sponsor
- Vanda Pharmaceuticals
- Conditions
- Generalized Pustular Psoriasis
- Interventions
- 750 mg Imsidolimab, 300 mg Imsidolimab, Placebo
- First posted
- 2022-04-29
- Last updated
- 2026-03-17
- Results first posted
- 2026-03-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear) | Week 4 | The Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) is a physician-based assessment of the overall disease severity of GPP at the time of evaluation (specifically pustules, erythema, and scaling/crusting of pustular psoriasis lesions). The GPPPGA is graded on a 5-point scale, ranging from 0 (clear) to 4 (severe). GPPPGA Scale: 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, 4 = Severe. |
| Secondary | Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear) | Week 1 | The Pustulation Rating Scale (PRS) is is a physician-based assessment of the severity of GPP pustulation. Pustulation is graded on a 5-point scale, ranging from 0 (clear) to 4 (severe). PRS Scale: 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear) | Week 4 | All participants randomized (1:1:1) to 750 mg imsidolimab, 300 mg imsidolimab , or placebo. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear) | Week 1 | All participants randomized (1:1:1) to 750 mg imsidolimab, 300 mg imsidolimab , or placebo. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear) | Imsidolimab 750 mg | 8 | 8.27 to 70.57 | Participants | |
| Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear) | Imsidolimab 300 mg | 8 | 8.66 to 71.47 | Participants | |
| Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear) | Placebo | 2 | NA to NA | Participants | |
| Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear) | Imsidolimab 750 mg | 6 | -3.74 to 57.07 | Participants | |
| Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear) | Imsidolimab 300 mg | 10 | 24.91 to 81.76 | Participants | |
| Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear) | Placebo | 2 | NA to NA | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imsidolimab 750 mg | 15 | |
| Overall Study | STARTED | Imsidolimab 300 mg | 15 | |
| Overall Study | STARTED | Placebo | 15 | |
| Overall Study | COMPLETED | Imsidolimab 750 mg | 11 | |
| Overall Study | COMPLETED | Imsidolimab 300 mg | 12 | |
| Overall Study | COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | Imsidolimab 750 mg | 4 | |
| Overall Study | NOT COMPLETED | Imsidolimab 300 mg | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 10 |
Source ClinicalTrials.gov
Adverse events81
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 | Urinary tract infection | Infections and infestations | Imsidolimab 750 mg | 0 | 15 | 0 |
| other | Urinary tract infection | Infections and infestations | Imsidolimab 300 mg | 2 | 15 | 2 |
| other | Urinary tract infection | Infections and infestations | Placebo | 1 | 15 | 2 |
| other | Upper respiratory tract infection | Infections and infestations | Imsidolimab 750 mg | 1 | 15 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | Imsidolimab 300 mg | 0 | 15 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 1 | 15 | 1 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Imsidolimab 750 mg | 1 | 15 | 1 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Imsidolimab 300 mg | 1 | 15 | 1 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo | 0 | 15 | 0 |
| other | Pyrexia | General disorders | Imsidolimab 750 mg | 0 | 15 | 0 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imsidolimab 750 mg | 0 | 15 |
| Total, all-cause mortality | Imsidolimab 300 mg | 0 | 15 |
| Total, all-cause mortality | Placebo | 0 | 15 |
| Total, other adverse events | Imsidolimab 750 mg | 6 | 15 |
| Total, other adverse events | Imsidolimab 300 mg | 5 | 15 |
| Total, other adverse events | Placebo | 11 | 15 |
| Total, serious adverse events | Imsidolimab 750 mg | 0 | 15 |
| Total, serious adverse events | Imsidolimab 300 mg | 0 | 15 |
| Total, serious adverse events | Placebo | 1 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42047557 | DERIVED |
Source PubMed
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/NCT05352893
GET https://conductscience.org/api/trials/v1/NCT05352893/events?page=2