Trial · NCT04697056
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Ichthyosis
NCT04697056, Phase 2, Terminated, Vanda Pharmaceuticals; results first posted 2023-03-02
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 the Treatment of Participants With Ichthyosis. Trials, record NCT04697056. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04697056
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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 the Treatment of Participants With Ichthyosis
- NCT number
- NCT04697056
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Vanda Pharmaceuticals
- Conditions
- Ichthyosis
- Interventions
- Imsidolimab, placebo
- First posted
- 2021-01-06
- Last updated
- 2025-09-16
- Other registries' IDs
- eudract:2020-003476-41
- Results first posted
- 2023-03-02
- Limitations and caveats
- As a result of insufficient recruitment of participants, this study was terminated.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Ichthyosis Area Severity Index (IASI) Total Score at Week 16 | Baseline and Week 16 | IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling \& percentage of body surface area (BSA) affected. Degree of erythema \& scaling scored from 0 (none) to 4 (very severe) for each of 4 body regions (BR) \[A1: head \& neck (H\&N), A2: upper limbs (UL), A3: trunk (T), A4: lower limbs (LL)\]. Percentage of BSA involved for each BR (B1: % in H\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value(0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6).Total extent was determined using multiplier considering % of total BSA by each BR (C1= 0.1 for H\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-Erythema (E)= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 (score 0 to 24) IASI-Scaling (S)= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 (score 0 to 24) IASI total score= IASI-E + IASI-S score ranged from 0 - 48, higher score indicated worse disease state. |
| Secondary | Percent Change From Baseline in IASI Total Score at Week 16 | Baseline and Week 16 | IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \& percentage of BSA affected. Degree of erythema \& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 (score 0 to 24) IASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 (score 0 to 24) IASI total score= IASI-E + IASI-S score ranged from 0 - 48, higher score indicated worse disease state. |
| Secondary | Percentage of Participants Achieving an Improvement of 50% From Baseline in IASI (IASI50) at Week 16 | Week 16 | IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \& percentage of BSA affected. Degree of erythema \& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 (score 0 to 24) IASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 (score 0 to 24) IASI total score= IASI-E + IASI-S score ranged from 0 - 48, higher score indicated worse disease state. |
| Secondary | Change From Baseline in IASI-E Scores at Week 16 | Baseline and Week 16 | IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \& percentage of BSA affected. Degree of erythema \& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 IASI-E score ranged from 0 - 24, higher score indicated worse disease state. |
| Secondary | Change From Baseline in IASI-S Scores at Week 16 | Baseline and Week 16 | IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \& percentage of BSA affected. Degree of erythema \& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 IASI-S score ranged from 0 - 24, higher score indicated worse disease state. |
| Secondary | Percent Change From Baseline in IASI-E Scores at Week 16 | Baseline and Week 16 | IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \& percentage of BSA affected. Degree of erythema \& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 IASI-E score ranged from 0 - 24, higher score indicated worse disease state. |
| Secondary | Percent Change From Baseline in IASI-S Scores at Week 16 | Baseline and Week 16 | IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, \& percentage of BSA affected. Degree of erythema \& scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H\&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 IASI-S score ranged from 0 - 24, higher score indicated worse disease state. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose up to study termination (maximum up to 9.4 weeks) | An AE was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of study treatment that did not necessarily have a causal relationship with this treatment. An AE was considered "serious" if there was any of the following outcomes: death, life-threatening adverse event, Inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. An adverse event was considered TE if the date of onset was during or after first dose of study treatment, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment. |
Source ClinicalTrials.gov
Outcomes8
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 Ichthyosis Area Severity Index (IASI) Total Score at Week 16 | Baseline and Week 16 | Due to early study termination before the primary time point, efficacy data was not collected, therefore, not analyzed. | ||
| SECONDARY | Percent Change From Baseline in IASI Total Score at Week 16 | Baseline and Week 16 | Due to early study termination before the primary time point, efficacy data was not collected, therefore, not analyzed. | ||
| SECONDARY | Percentage of Participants Achieving an Improvement of 50% From Baseline in IASI (IASI50) at Week 16 | Week 16 | Due to early study termination before the primary time point, efficacy data was not collected, therefore, not analyzed. | ||
| SECONDARY | Change From Baseline in IASI-E Scores at Week 16 | Baseline and Week 16 | Due to early study termination before the primary time point, efficacy data was not collected, therefore, not analyzed. | ||
| SECONDARY | Change From Baseline in IASI-S Scores at Week 16 | Baseline and Week 16 | Due to early study termination before the primary time point, efficacy data was not collected, therefore, not analyzed. | ||
| SECONDARY | Percent Change From Baseline in IASI-E Scores at Week 16 | Baseline and Week 16 | Due to early study termination before the primary time point, efficacy data was not collected, therefore, not analyzed. | ||
| SECONDARY | Percent Change From Baseline in IASI-S Scores at Week 16 | Baseline and Week 16 | Due to early study termination before the primary time point, efficacy data was not collected, therefore, not analyzed. | ||
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose up to study termination (maximum up to 9.4 weeks) | Safety analysis set included all randomized participants who received at least 1 dose of imsidolimab or placebo. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Imsidolimab | Any TEAEs | 1 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Placebo | Any TEAEs | 1 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Imsidolimab | Serious TEAEs | 0 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Placebo | Serious TEAEs | 0 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imsidolimab | 4 | |
| Overall Study | STARTED | Placebo | 1 | |
| Overall Study | COMPLETED | Imsidolimab | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Imsidolimab | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events16
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 | Fatigue | General disorders | Imsidolimab | 1 | 4 | 1 |
| other | Fatigue | General disorders | Placebo | 0 | 1 | 0 |
| other | Peripheral swelling | General disorders | Imsidolimab | 0 | 4 | 0 |
| other | Peripheral swelling | General disorders | Placebo | 1 | 1 | 1 |
| other | Herpes simplex reactivation | Infections and infestations | Imsidolimab | 1 | 4 | 1 |
| other | Herpes simplex reactivation | Infections and infestations | Placebo | 0 | 1 | 0 |
| other | Procedural pain | Injury, poisoning and procedural complications | Imsidolimab | 0 | 4 | 0 |
| other | Procedural pain | Injury, poisoning and procedural complications | Placebo | 1 | 1 | 1 |
| other | Inguinal mass | Musculoskeletal and connective tissue disorders | Imsidolimab | 0 | 4 | 0 |
| other | Inguinal mass | Musculoskeletal and connective tissue disorders | Placebo | 1 | 1 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imsidolimab | 0 | 4 |
| Total, all-cause mortality | Placebo | 0 | 1 |
| Total, other adverse events | Imsidolimab | 1 | 4 |
| Total, other adverse events | Placebo | 1 | 1 |
| Total, serious adverse events | Imsidolimab | 0 | 4 |
| Total, serious adverse events | Placebo | 0 | 1 |
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/NCT04697056
GET https://conductscience.org/api/trials/v1/NCT04697056/registered