Phase 2
N=8
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis
Generalized Pustular Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT03619902 ↗Enrolled (actual)
8
Serious AEs
25.0%
Results posted
Mar 2022
Primary outcome: Primary: Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale — 75.0; 75.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Imsidolimab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanda Pharmaceuticals
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale |
75.0; 75.0 | — |
| PRIMARY Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16 |
-59.63; -94.17; -97.78 | — |
| SECONDARY Percent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16 |
-25.74; -55.65; -62.20 | — |
| SECONDARY Percentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16 |
0.0; 50.0; 75.0 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16 |
-0.9; -6.0; -10.7 | — |
Summary
The main objectives of this study are to evaluate the efficacy, safety and tolerability of imsidolimab in adults with active GPP.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of active GPP
- Japanese Dermatology Association (JDA) severity index total score of at least 6 and erythema with pustules accounting for at least 10% of body surface area or a moderate severity score on Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA)
- Must be candidates for systemic therapy or phototherapy
Exclusion Criteria
- Erythrodermic, guttate psoriasis, drug induced GPP
- Any other ongoing inflammatory disease that interfere with the Investigator's ability to evaluate the subject's response to therapy
- History of recurrent or chronic infection
- ongoing use of psoriasis prohibited medication
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03619902). 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.