IchthyosisPhase 2NCT04697056
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Ichthyosis
A Phase 2 study testing Imsidolimab in people with Ichthyosis, run by Vanda Pharmaceuticals at 7 sites in United States.
Trial summary
Efficacy and Safety of imsidolimab in Participants with Ichthyosis Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Ichthyosis
- What is being tested?
- Imsidolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Jan 2021to 19 Nov 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Ichthyosis
- IASI total score ≥ 18, erythema score ≥ 2
- Participant has been using emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily at the same frequency throughout the study
Who cannot join
- A participant with ichthyosis vulgaris, X-linked ichthyosis, or lamellar ichthyosis will be excluded.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Site 101
Chicago, Illinois, 60611
Site 102
Columbus, Ohio, 43215
Site 112
Miami, Florida, 33125
Site 104
New Haven, Connecticut, 06519
Site 106
Palo Alto, California, 94304
Site 105
Salt Lake City, Utah, 84132
Site 107
San Antonio, Texas, 78218
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Subjects With Ichthyosis
Efficacy and Safety of imsidolimab in Participants with Ichthyosis
Read the detailed description
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.
- Conditions
- Ichthyosis
- Being tested
- Imsidolimab, placebo
- Keywords
- IL-36 Receptor, Interleukin 36, Imsidolimab
- Medical subject headings
- Ichthyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImsidolimabDrug
Also called ANB019
Humanized Monoclonal Antibody
placeboBiological
placebo
| Study group | Role | What they receive |
|---|---|---|
| Imsidolimab | Experimental | 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. Receives: Drug: Imsidolimab |
| Placebo | Placebo comparator | Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 16
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From first dose up to study termination (maximum up to 9.4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start25 Jan 2021
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Why it stopped: Administrative Reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for IchthyosisStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697056
- Sponsor's protocol ID
- ANB019-206
- Other IDs
- 2020-003476-41
- Status last verified
- Nov 2022
- First submitted
- 23 Dec 2020
- Last updated
- 16 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Subjects With Ichthyosis
- ClinicalTrials.gov ID
- NCT04697056
- Acronym / sponsor ID
- ANB019-206
- Conditions
- Ichthyosis
- Keywords
- IL-36 Receptor, Interleukin 36, Imsidolimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative Reason
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Posted 2 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy and Safety of imsidolimab in Participants with Ichthyosis
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imsidolimab | Experimental | Drug: ImsidolimabParticipants 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. |
| Placebo | Placebo comparator | Biological: placeboParticipants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Ichthyosis
- IASI total score ≥ 18, erythema score ≥ 2
- Participant has been using emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily at the same frequency throughout the study
Key exclusion criteria (1 listed)
- A participant with ichthyosis vulgaris, X-linked ichthyosis, or lamellar ichthyosis will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImsidolimabAlso: ANB019Humanized Monoclonal Antibody | Drug | Imsidolimab |
| placeboplacebo | Biological | Placebo |
Primary outcome
Change From Baseline in Ichthyosis Area Severity Index (IASI) Total Score at Week 16
Time frame: 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.
7 secondary outcomes
Percent Change From Baseline in IASI Total Score at Week 16
Time frame: Baseline and Week 16
Percentage of Participants Achieving an Improvement of 50% From Baseline in IASI (IASI50) at Week 16
Time frame: Week 16
Change From Baseline in IASI-E Scores at Week 16
Time frame: Baseline and Week 16
Change From Baseline in IASI-S Scores at Week 16
Time frame: Baseline and Week 16
Percent Change From Baseline in IASI-E Scores at Week 16
Time frame: Baseline and Week 16
Percent Change From Baseline in IASI-S Scores at Week 16
Time frame: Baseline and Week 16
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From first dose up to study termination (maximum up to 9.4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imsidolimab in people with Ichthyosis, run by Vanda Pharmaceuticals at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Ichthyosis Area Severity Index (IASI) Total Score at Week 16 (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.