Palmoplantar PustulosisPhase 2POPLARNCT03633396
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis
A Phase 2 study testing Imsidolimab in people with Palmoplantar Pustulosis, run by Vanda Pharmaceuticals at 39 sites in 4 countries.
Trial summary
A study to evaluate the efficacy and safety, and pharmacokinetic (PK) profile of multiple doses of imsidolimab (ANB019) in adults with palmoplantar pustulosis (PPP) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Palmoplantar Pustulosis
- 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
- 59 participants
- Where
- 39 sitesin 4 countries
- Study dates
- 20 May 2019to 23 Apr 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically confirmed diagnosis of PPP
- Disease duration of at least 6 months prior to screening
- Present with active pustules on palms or/and soles at screening
Who cannot join
- Any other ongoing inflammatory disease that interfere with the investigator's ability to evaluate the subject's response to therapy
- History of recurrent or active/serious infection
- Ongoing use of psoriasis prohibited medication
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
39 sites in 4 countries.
39 sites in 4 countries
United States19 sites
Investigational Site
Ann Arbor, Michigan, 48109
Investigational Site
Birmingham, Alabama, 35233
Investigational Site
Columbus, Ohio, 43230
Investigational Site
Dallas, Texas, 75230
Investigational Site
Encino, California, 91436
Investigational Site
Fort Lauderdale, Florida, 33316
Investigational Site
Indianapolis, Indiana, 46250
Investigational Site
Miami, Florida, 33155
Investigational Site
Norman, Oklahoma, 73071
Investigational Site
Overland Park, Kansas, 66215
Investigational Site
Pembroke Pines, Florida, 33028
Investigational Site
Phoenix, Arizona, 85032
Investigational Site
Plainfield, Indiana, 46168
Investigational Site
Portland, Oregon, 97239
Investigational Site
Santa Monica, California, 90405
Investigational Site
St Louis, Missouri, 63110
Investigational Site
St Louis, Missouri, 63117
Investigational Site
Tampa, Florida, 33607
Investigational Site
Wilmington, North Carolina, 28405
Poland8 sites
Investigational Site
Gdansk, 80-546
Investigational Site
Katowice, 40-611
Investigational Site
Lodz, 90-265
Investigational Site
Olsztyn, 10-229
Investigational Site
Ostrowiec Świętokrzyski, 27-400
Investigational Site
Rzeszów, 35-055
Investigational Site
Szczecin, 70-332
Investigational Site
Wroclaw, 50-566
Germany7 sites
Investigational Site
Bad Bentheim, 48455
Investigational Site
Berlin, 10117
Investigational Site
Berlin, 10789
Investigational Site
Bonn, 53127
Investigational Site
Hamburg, 20253
Investigational Site
Hamburg, 22391
Investigational Site
Schwerin, 19055
Canada5 sites
Investigational Site
Drummondville, Quebec
Investigational Site
Greater Sudbury, Ontario
Investigational Site
Markham, Ontario
Investigational Site
Montreal, Quebec
Investigational Site
Surrey, British Columbia
About this study
Official title: A Phase 2, Randomized, Placebo-controlled, Double-blind, Multiple Dose Study to Evaluate the Efficacy and Safety of ANB019 in Subjects With Palmoplantar Pustulosis
A study to evaluate the efficacy and safety, and pharmacokinetic (PK) profile of multiple doses of imsidolimab (ANB019) in adults with palmoplantar pustulosis (PPP)
- Conditions
- Palmoplantar Pustulosis
- Being tested
- Imsidolimab, Placebo
- Keywords
- PPP
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImsidolimabBiological
Also called ANB019
Administered by subcutaneous injection once a month
PlaceboDrug
Administered by subcutaneous injection once a month
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive placebo administered by subcutaneous injection on Day 1 followed by monthly doses of placebo by subcutaneous injection on Days 29, 57, and 85. Receives: Drug: Placebo |
| imsidolimab | Experimental | Participants will receive 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85. Receives: Biological: Imsidolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI)
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.
Measured: Baseline to Week 16
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
Measured: From first dose of any study drug to Week 24
Secondary outcomes (2)
Percentage of Participants Who Achieved 50% Reduction (Improvement) From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index Score (PPPASI 50)
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.
Measured: Baseline to Week 16
Percentage of Participants Who Achieved a Clear or Almost Clear Palmoplantar Pustulosis Investigator's Global Assessment (PPPIGA) Score at 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.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start20 May 2019
- Primary completion23 Apr 2021
- Study completion23 Apr 2021
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 Palmoplantar PustulosisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 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
- NCT03633396
- Sponsor's protocol ID
- ANB019-003
- Other IDs
- 2017-004022-15, 2017
- Acronym
- POPLAR
- Status last verified
- May 2022
- First submitted
- 19 Jul 2018
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Placebo-controlled, Double-blind, Multiple Dose Study to Evaluate the Efficacy and Safety of ANB019 in Subjects With Palmoplantar Pustulosis
- ClinicalTrials.gov ID
- NCT03633396
- Acronym / sponsor ID
- POPLAR / ANB019-003
- Conditions
- Palmoplantar Pustulosis
- Keywords
- PPP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 May 2019 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Posted 31 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the efficacy and safety, and pharmacokinetic (PK) profile of multiple doses of imsidolimab (ANB019) in adults with palmoplantar pustulosis (PPP)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo administered by subcutaneous injection on Day 1 followed by monthly doses of placebo by subcutaneous injection on Days 29, 57, and 85. |
| imsidolimab | Experimental | Biological: ImsidolimabParticipants will receive 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically confirmed diagnosis of PPP
- Disease duration of at least 6 months prior to screening
- Present with active pustules on palms or/and soles at screening
Key exclusion criteria (4 listed)
- Any other ongoing inflammatory disease that interfere with the investigator's ability to evaluate the subject's response to therapy
- History of recurrent or active/serious infection
- Ongoing use of psoriasis prohibited medication
- Other protocol-defined inclusion/exclusion criteria may apply
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: ANB019Administered by subcutaneous injection once a month | Biological | imsidolimab |
| PlaceboAdministered by subcutaneous injection once a month | Drug | Placebo |
Primary outcome
Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI)
Time frame: 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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: 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.
2 secondary outcomes
Percentage of Participants Who Achieved 50% Reduction (Improvement) From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index Score (PPPASI 50)
Time frame: Baseline to Week 16
Percentage of Participants Who Achieved a Clear or Almost Clear Palmoplantar Pustulosis Investigator's Global Assessment (PPPIGA) Score at Week 16
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
39 sites in 4 countries: 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 Palmoplantar Pustulosis, run by Vanda Pharmaceuticals at 39 sites in 4 countries.
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 4 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: finished, as of the sponsor's last update on 15 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 39 sites in United States, Poland, Germany, Canada. 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 31 May 2022). 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 Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI) (time frame: Baseline to Week 16). The study lists 2 primary outcomes in all. 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 15 Sep 2025.