Trial · NCT03633396
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis
NCT03633396, Phase 2, Completed, Vanda Pharmaceuticals; results first posted 2022-05-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis. Trials, record NCT03633396. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03633396
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis
- NCT number
- NCT03633396
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- Vanda Pharmaceuticals
- Conditions
- Palmoplantar Pustulosis
- Interventions
- Imsidolimab, Placebo
- First posted
- 2018-08-16
- Last updated
- 2025-09-15
- Other registries' IDs
- eudract:2017-004022-15
- Results first posted
- 2022-05-31
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI) | Baseline to Week 16 | The Palmoplantar Pustulosis Area and Severity Index (PPPASI) is used to assess the severity of palmoplantar pustulosis lesions and their response to therapy. The glabrous skin of both palms and both soles are assessed for erythema, pustules, and desquamation (scaling), each on a scale from 0 (none) to 4 (very severe). The area affected of each palm and sole is scored from 0 (0%) to 6 (90-100%). Scores for the 3 characteristics of PPP are summed and adjusted for the area affected, and the scores for each palm and sole are added to calculate the total score. The PPPASI total score ranges from 0 to 72. A higher score indicates more severe disease, and a negative change from Baseline indicates improvement. |
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of any study drug to Week 24 | Clinical safety was evaluated by reporting incidence of adverse events up to week 24. TEAEs are defined as new events that occured during or after first dose of study drug or any event that worsens after first dose of study drug. A serious AE (SAE) is defined as any untoward medical occurrence that resulted in death, was life-threatening, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or an important medical event that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above. Severity was assessed by the Investigator as mild (easily tolerated, causing minimal discomfort and not interfering with everyday activities), moderate (causes sufficient discomfort and interferes with normal everyday activities) or severe (prevents normal everyday activities). The Investigator assessed the relationship between study treatment and each AE based on clinical judgement. |
| Secondary | Percentage of Participants Who Achieved 50% Reduction (Improvement) From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index Score (PPPASI 50) | Baseline to Week 16 | The Palmoplantar Pustulosis Area and Severity Index (PPPASI) is used to assess the severity of palmoplantar pustulosis lesions and their response to therapy. The glabrous skin of both palms and both soles are assessed for erythema, pustules, and desquamation (scaling), each on a scale from 0 (none) to 4 (very severe). The area affected of each palm and sole is scored from 0 (0%) to 6 (90-100%). Scores for the 3 characteristics of PPP are summed and adjusted for the area affected, and the scores for each palm and sole are added to calculate the total score. The PPPASI total score ranges from 0 to 72. A higher score indicates more severe disease. |
| Secondary | Percentage of Participants Who Achieved a Clear or Almost Clear Palmoplantar Pustulosis Investigator's Global Assessment (PPPIGA) Score at Week 16 | Week 16 | The Investigator rated the severity of participants' disease on the following 5-point scale: * 0: Clear - No signs of palmoplantar pustulosis; no scaling or crusts or pustules remain; * 1: Almost clear - Slight scaling and/or erythema and/or slight crusts; very few (yellow) and/or old (brown) pustules; * 2: Mild - Scaling and/or erythema and/or crusts; visible new (yellow) and/or old (brown) pustules of limited number and extent; * 3: Moderate - Prominent scaling and/or erythema and/or crusting; prominent new (yellow) and/or old (brown) pustules covering most of the area involved; * 4: Severe - Severe scaling and/or erythema and/or crusting; numerous new (yellow) and/or old (brown) pustules with / without major confluence, covering the entire area of at least 2 palmoplantar sites. |
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 | Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI) | Baseline to Week 16 | Intent-to-treat analysis set with available data | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of any study drug to Week 24 | Safety Analysis Set (all randomized participants who received at least 1 dose of imsidolimab or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Achieved 50% Reduction (Improvement) From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index Score (PPPASI 50) | Baseline to Week 16 | Intent-to-treat analysis set with available data | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a Clear or Almost Clear Palmoplantar Pustulosis Investigator's Global Assessment (PPPIGA) Score at Week 16 | Week 16 | Intent-to-treat analysis set with available data | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI) | Placebo | -6.0 | Standard Error 1.48 | score on a scale | |
| Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI) | Imsidolimab | -6.1 | Standard Error 1.46 | score on a scale | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Placebo | Any treatment-emergent adverse event (TEAE) | 20 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Imsidolimab | Any treatment-emergent adverse event (TEAE) | 21 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Placebo | TEAE related to study drug | 3 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Imsidolimab | TEAE related to study drug | 6 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Placebo | Severe TEAE | 1 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Imsidolimab | Severe TEAE | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Placebo | Serious TEAE | 1 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Imsidolimab | Serious TEAE | 0 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 29 | |
| Overall Study | STARTED | Imsidolimab | 30 | |
| Overall Study | COMPLETED | Placebo | 23 | |
| Overall Study | COMPLETED | Imsidolimab | 24 | |
| Overall Study | NOT COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | Imsidolimab | 6 |
Source ClinicalTrials.gov
Adverse events124
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 | Placebo | 4 | 29 | |
| other | Nasopharyngitis | Infections and infestations | Imsidolimab | 4 | 30 | |
| other | Pharyngitis | Infections and infestations | Placebo | 0 | 29 | |
| other | Pharyngitis | Infections and infestations | Imsidolimab | 2 | 30 | |
| other | COVID-19 | Infections and infestations | Placebo | 2 | 29 | |
| other | COVID-19 | Infections and infestations | Imsidolimab | 1 | 30 | |
| other | Otitis externa | Infections and infestations | Placebo | 0 | 29 | |
| other | Otitis externa | Infections and infestations | Imsidolimab | 1 | 30 | |
| other | Rhinitis | Infections and infestations | Placebo | 0 | 29 | |
| other | Rhinitis | Infections and infestations | Imsidolimab | 1 | 30 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 29 |
| Total, all-cause mortality | Imsidolimab | 0 | 30 |
| Total, other adverse events | Placebo | 20 | 29 |
| Total, other adverse events | Imsidolimab | 21 | 30 |
| Total, serious adverse events | Placebo | 1 | 29 |
| Total, serious adverse events | Imsidolimab | 0 | 30 |
Source ClinicalTrials.gov
Papers0
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Imsidolimab vs Placebo: deaths from any cause | Trial comparisons |
| Imsidolimab vs Placebo: serious adverse events | Trial comparisons |
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/NCT03633396
GET https://conductscience.org/api/trials/v1/NCT03633396/results?page=2