A Phase 2 interventional study of Imsidolimab and placebo in Ichthyosis, sponsored by Vanda Pharmaceuticals. Terminated at 7 sites in United States. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Vanda Pharmaceuticals · Phase 2, Interventional, and Treatment
Efficacy and Safety of imsidolimab in Participants with Ichthyosis
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of imsidolimab compared with placebo in adolescent and adult participants with ichthyosis. This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with ichthyosis.
33 studies on the registry are indexed under Ichthyosis; 11 are open to participants now.
This study's enrollment of 5 is below the median of 26 across 23 interventional studies indexed under Ichthyosis.
Browse Ichthyosis studies →Vanda Pharmaceuticals is the lead sponsor of 82 studies on the registry; 17 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 22 (67%) have results posted.
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Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
Drug: Imsidolimab
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
Biological: placebo
Humanized Monoclonal Antibody
Also known as: ANB019
placebo
Change From Baseline in Ichthyosis Area Severity Index (IASI) Total Score at 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.
Time frame: Baseline and Week 16
Percent Change From Baseline in IASI Total Score at 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.
Time frame: Baseline and Week 16
Percentage of Participants Achieving an Improvement of 50% From Baseline in IASI (IASI50) at 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.
Time frame: Week 16
Change From Baseline in IASI-E Scores at 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.
Time frame: Baseline and Week 16
Change From Baseline in IASI-S Scores at 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.
Time frame: Baseline and Week 16
Percent Change From Baseline in IASI-E Scores at 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.
Time frame: Baseline and Week 16
Percent Change From Baseline in IASI-S Scores at 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.
Time frame: Baseline and Week 16
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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.
Time frame: From first dose up to study termination (maximum up to 9.4 weeks)
Participants with confirmed diagnosis of ichthyosis by genetic testing of ichthyosis were enrolled into the study.
| Milestone | Imsidolimab | Placebo |
|---|---|---|
| Started | 4 | 1 |
| Completed | 0 | 0 |
| Not completed | 4 | 1 |
| Withdrew: Termination of the participant participation by the investigator or sponsor | 4 | 1 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
| participants | Imsidolimab | Placebo |
|---|---|---|
| Any TEAEs | 1 | 1 |
| Serious TEAEs | 0 | 0 |
Collected over From first dose up to study termination (maximum up to 9.4 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Imsidolimab | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) |
| Placebo | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Imsidolimab | Placebo |
|---|---|---|
| Peripheral swellingGeneral disorders | 0/4 | 1/1 |
| Procedural painInjury, poisoning and procedural complications | 0/4 | 1/1 |
| Inguinal massMusculoskeletal and connective tissue disorders | 0/4 | 1/1 |
| Night sweatsSkin and subcutaneous tissue disorders | 0/4 | 1/1 |
| Skin lesionSkin and subcutaneous tissue disorders | 0/4 | 1/1 |
| FatigueGeneral disorders | 1/4 | 0/1 |
| Herpes simplex reactivationInfections and infestations | 1/4 | 0/1 |
| HeadacheNervous system disorders | 1/4 | 0/1 |
Intent-to-Treat (ITT) analysis set included all randomized participants.
| Age, Continuous(years) | Imsidolimab | Placebo | Total |
|---|---|---|---|
| Mean | 39.0 ± 20.15 | 66.0 | 44.4 ± 21.22 |
| Sex: Female, Male(Participants) | Imsidolimab | Placebo | Total |
|---|---|---|---|
| Female | 3 | 0 | 3 |
| Male | 1 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Imsidolimab | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 4 | 1 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Imsidolimab | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 1 | 0 | 1 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Imsidolimab