Trials / Completed
CompletedNCT05352893
Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Vanda Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).
Detailed description
This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 750 mg Imsidolimab | Intravenous |
| DRUG | 300 mg Imsidolimab | Intravenous |
| OTHER | Placebo | Intravenous |
Timeline
- Start date
- 2022-04-14
- Primary completion
- 2023-08-17
- Completion
- 2023-08-17
- First posted
- 2022-04-29
- Last updated
- 2026-03-17
- Results posted
- 2026-03-17
Locations
65 sites across 15 countries: United States, Australia, France, Georgia, Germany, Malaysia, Morocco, Poland, Romania, South Korea, Spain, Taiwan, Thailand, Tunisia, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05352893. Inclusion in this directory is not an endorsement.