Phase 2
N=59
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis
Palmoplantar Pustulosis
Bottom Line
View on ClinicalTrials.gov: NCT03633396 ↗Enrolled (actual)
59
Serious AEs
1.7%
Results posted
May 2022
Primary outcome: Primary: Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI) — -6.0; -6.1 score on a scale — p=0.944
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Imsidolimab (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanda Pharmaceuticals
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI) |
-6.0; -6.1 | 0.944 |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
20; 21; 3; 6; 1; 0 | — |
| SECONDARY Percentage of Participants Who Achieved 50% Reduction (Improvement) From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index Score (PPPASI 50) |
50.0; 45.8 | — |
| SECONDARY Percentage of Participants Who Achieved a Clear or Almost Clear Palmoplantar Pustulosis Investigator's Global Assessment (PPPIGA) Score at Week 16 |
12.5; 20.8 | — |
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)
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03633396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.