Trial · NCT03619902
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis
NCT03619902, Phase 2, Completed, Vanda Pharmaceuticals; results first posted 2022-03-29
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 Generalized Pustular Psoriasis. Trials, record NCT03619902. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03619902
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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 Generalized Pustular Psoriasis
- NCT number
- NCT03619902
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Vanda Pharmaceuticals
- Conditions
- Generalized Pustular Psoriasis
- Interventions
- Imsidolimab
- First posted
- 2018-08-08
- Last updated
- 2025-09-16
- Other registries' IDs
- eudract:2017-004021-33
- Results first posted
- 2022-03-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale | Week 4 and Week 16 | Clinical response was defined as "Very much improved," "Much Improved," or "Minimally Improved" on the CGI scale according to the Modified Japanese Dermatological Association Severity Index (JDA-SI) total score. The JDA-SI includes assessment of skin lesions (area of erythema with pustules, area of erythema total, and area of edema) and fever, white blood cell count, C-reactive protein and serum albumin levels. The total score ranges from 0 to 17 (severe). CGI was assessed based on the JDA-SI according to the following: * Very Much Improved: Reduction in JDA-SI total score by 3 or \> points; * Much improved: Reduction in JDA-SI total score by 1 or 2 points; * Minimally improved: No change in JDA-SI total score and area of erythema with pustules reduced by \<20% or clinically meaningful improvement in at least 1 other component of the modified JDA-SI. |
| Primary | Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16 | Baseline, Week 1, Week 4, and Week 16 | Excluding palms and soles from 0% to 100%. The palmar surface of one hand (using the subject's hand and including the fingers) represents 1% of his or her total BSA. |
| Secondary | Percent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16 | Baseline, Week 1, Week 4, and Week 16 | The area of erythema with pustules, area of total erythema and area of edema were assessed by the Investigator and scored from 0 to 3 on the following scale: * 0: 0% body surface area (BSA) affected; * 1: \> 0%, \< 10% BSA affected; * 2: ≥ 10%, \< 50% BSA affected; * 3: ≥ 50% BSA affected. The JDA-SI Total Skin Lesions Score is the sum of the area of erythema with pustules score, area of total erythema score and area of edema score and ranges between 0 and 9 (worst). A negative change from Baseline indicates improvement. |
| Secondary | Percentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16 | Week 1, Week 4, and Week 16 | The GPPPGA scale was used to assess the impact and severity of GPP on the following scale: * 0: Clear (normal skin or post-inflammatory hyperpigmentation, no visible pustules, no scaling or crusting). * 1: Almost clear (faint, diffuse pink or slight red erythema, low density occasional small discrete pustules (noncoalescent), superficial focal scaling or crusting restricted to periphery of lesions). * 2: Mild (light red erythema, moderate density grouped discrete small pustules (noncoalescent), predominantly fine scaling or crusting). * 3: Moderate (bright red erythema, high density pustules with some coalescence, moderate scaling or crusting covering most or all lesions). * 4: Severe (deep fiery red erythema, very high density pustules with pustular lakes, severe scaling or crusting covering most or all lesions). |
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16 | Baseline and Week 1, Week 4, and Week 16 | The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that their skin problem has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement. |
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 | Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale | Week 4 and Week 16 | The full analysis set (FAS) included all enrolled participants. Participants with missing data were categorized as non-responders. | percentage of participants | NUMBER |
| PRIMARY | Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16 | Baseline, Week 1, Week 4, and Week 16 | Full analysis set participants with available data at each time point | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16 | Baseline, Week 1, Week 4, and Week 16 | Full analysis set participants with available data at each time point | percent change | MEAN |
| SECONDARY | Percentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16 | Week 1, Week 4, and Week 16 | Full Analysis Set participants with GPPPGA at Baseline and at each time point | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16 | Baseline and Week 1, Week 4, and Week 16 | Full analysis set participants with available data at each time point | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale | Imsidolimab | Week 4 | 75.0 | 95% Confidence Interval 34.91 to 96.81 | percentage of participants |
| Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale | Imsidolimab | Week 16 | 75.0 | 95% Confidence Interval 34.91 to 96.81 | percentage of participants |
| Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16 | Imsidolimab | Week 1 | -59.63 | Standard Deviation 39.895 | percent change |
| Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16 | Imsidolimab | Week 4 | -94.17 | Standard Deviation 10.737 | percent change |
| Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16 | Imsidolimab | Week 16 | -97.78 | Standard Deviation 5.443 | percent change |
| Percent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16 | Imsidolimab | Week 1 | -25.74 | Standard Deviation 26.369 | percent change |
| Percent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16 | Imsidolimab | Week 4 | -55.65 | Standard Deviation 27.157 | percent change |
| Percent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16 | Imsidolimab | Week 16 | -62.20 | Standard Deviation 29.757 | percent change |
| Percentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16 | Imsidolimab | Week 1 | 0.0 | 95% Confidence Interval 0.00 to 52.18 | percentage of participants |
| Percentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16 | Imsidolimab | Week 4 | 50.0 | 95% Confidence Interval 6.76 to 93.24 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imsidolimab | 8 | |
| Overall Study | COMPLETED | Imsidolimab | 6 | |
| Overall Study | NOT COMPLETED | Imsidolimab | 2 |
Source ClinicalTrials.gov
Adverse events21
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 | Anaemia | Blood and lymphatic system disorders | Imsidolimab | 1 | 8 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Imsidolimab | 1 | 8 | 3 |
| other | Blood folate decreased | Investigations | Imsidolimab | 1 | 8 | 1 |
| other | Blood glucose increased | Investigations | Imsidolimab | 1 | 8 | 1 |
| other | C-reactive protein increased | Investigations | Imsidolimab | 1 | 8 | 1 |
| other | White blood cell count increased | Investigations | Imsidolimab | 1 | 8 | 1 |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Imsidolimab | 2 | 8 | 2 |
| other | Psoriasis | Skin and subcutaneous tissue disorders | Imsidolimab | 1 | 8 | 1 |
| other | Skin haemorrhage | Skin and subcutaneous tissue disorders | Imsidolimab | 1 | 8 | 1 |
| other | Mitral valve prolapse | Cardiac disorders | Imsidolimab | 1 | 8 | 1 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imsidolimab | 0 | 8 |
| Total, other adverse events | Imsidolimab | 6 | 8 |
| Total, serious adverse events | Imsidolimab | 2 | 8 |
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 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/NCT03619902
GET https://conductscience.org/api/trials/v1/NCT03619902/events?page=2