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NCT05352893: GEMINI-1

Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP

Completed Phase 3 Results posted Last updated 17 March 2026
What this trial tests

Phase 3 trial testing 750 mg Imsidolimab in Generalized Pustular Psoriasis in 45 participants. Completed in 17 August 2023.

Timeline
14 April 2022
Primary endpoint
17 August 2023
17 August 2023

Quick facts

Lead sponsorVanda Pharmaceuticals
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment45
Start date14 April 2022
Primary completion17 August 2023
Estimated completion17 August 2023
Sites65 locations across Georgia, France, Tunisia, Malaysia, Taiwan, Germany, Poland, South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Vanda Pharmaceuticals — full company profile →

Who can join

Adults 18 to 80, any sex, with Generalized Pustular Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear) Primary · Week 4

The Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) is a physician-based assessment of the overall disease severity of GPP at the time of evaluation (specifically pustules, erythema, and scaling/crusting of pustular psoriasis lesions). The GPPPGA is graded on a 5-point scale, ranging from 0 (clear) to 4 (severe). GPPPGA Scale: 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, 4 = Severe.

GroupValue95% CI
Imsidolimab 750 mg88.27 – 70.57
Imsidolimab 300 mg88.66 – 71.47
Placebo2NA – NA
Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear) Secondary · Week 1

The Pustulation Rating Scale (PRS) is is a physician-based assessment of the severity of GPP pustulation. Pustulation is graded on a 5-point scale, ranging from 0 (clear) to 4 (severe). PRS Scale: 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe.

GroupValue95% CI
Imsidolimab 750 mg6-3.74 – 57.07
Imsidolimab 300 mg1024.91 – 81.76
Placebo2NA – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: All Adverse Events (AEs) were collected from signature of the informed consent up to the final Safety Follow-up Visit (Week 12) regardless of seriousness or relationship to investigational product.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Imsidolimab 750 mg
Serious: 0/15 (0%)
Deaths: 0/15
Imsidolimab 300 mg
Serious: 0/15 (0%)
Deaths: 0/15
Placebo
Serious: 1/15 (7%)
Deaths: 0/15

Serious adverse events (1 terms)

ReactionSystemImsidolimab 750 mgImsidolimab 300 mgPlacebo
SepsisInfections and infestations
Other adverse events (26 terms — click to expand)

ReactionSystemImsidolimab 750 mgImsidolimab 300 mgPlacebo
Urinary tract infectionInfections and infestations
PyrexiaGeneral disorders
HeadacheNervous system disorders
Pustular psoriasisSkin and subcutaneous tissue disorders
Upper respiratory tract infectionInfections and infestations
PruritusSkin and subcutaneous tissue disorders
Skin infectionInfections and infestations
ChillsGeneral disorders
Abdominal painGastrointestinal disorders
LeukopeniaBlood and lymphatic system disorders
NeutropeniaBlood and lymphatic system disorders
Weight increasedInvestigations
InsomniaPsychiatric disorders
Eyelid skin drynessEye disorders
HypertriglyceridaemiaMetabolism and nutrition disorders
Respiratory tract congestionRespiratory, thoracic and mediastinal disorders
Tooth extractionSurgical and medical procedures
HordeolumInfections and infestations
AlopeciaSkin and subcutaneous tissue disorders
PsoriasisSkin and subcutaneous tissue disorders
NauseaGastrointestinal disorders
VomitingGastrointestinal disorders
HyperleukocytosisBlood and lymphatic system disorders
Blood potassium decreasedInvestigations
AnxietyPsychiatric disorders
Menstruation irregularReproductive system and breast disorders

Most-reported serious reactions: Sepsis.

Data from ClinicalTrials.gov NCT05352893 adverse events section.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Antibodies to watch in 2024.
    Crescioli S, Kaplon H, Chenoweth A, Wang L, et al · · 2024 · cited 122× · PMID 38178784 · DOI 10.1080/19420862.2023.2297450
  2. IL-1 Family Cytokines in Inflammatory Dermatoses: Pathogenetic Role and Potential Therapeutic Implications.
    Iznardo H, Puig L. · · 2022 · cited 44× · PMID 36012744 · DOI 10.3390/ijms23169479
  3. A Review of the Clinical Trial Landscape in Psoriasis: An Update for Clinicians.
    Drakos A, Vender R. · · 2022 · cited 15× · PMID 36319883 · DOI 10.1007/s13555-022-00840-9
  4. The role of the interleukin-36 axis in generalized pustular psoriasis: a review of the mechanism of action of spesolimab.
    Hawkes JE, Visvanathan S, Krueger JG. · · 2023 · cited 11× · PMID 38077370 · DOI 10.3389/fimmu.2023.1292941
  5. Current Treatments for Generalized Pustular Psoriasis: A Narrative Summary of a Systematic Literature Search.
    Puig L, Fujita H, Thaçi D, Zheng M, et al · · 2024 · cited 8× · PMID 39088126 · DOI 10.1007/s13555-024-01230-z
  6. Diseases categorized as autoinflammatory keratinization diseases (AiKDs), and their pathologies and treatments.
    Akiyama M. · · 2024 · cited 6× · PMID 38505726 · DOI 10.18999/nagjms.86.1.1
  7. New and Emerging Treatments for Generalized Pustular Psoriasis: Focus on IL-36 Receptor Inhibitors.
    Vilaça J, Yilmaz O, Torres T. · · 2024 · cited 5× · PMID 39065604 · DOI 10.3390/pharmaceutics16070908
  8. T Cell Immunosenescence in Inflammatory Skin Diseases: Pathogenesis and Therapeutic Targets.
    Liu C, Yang M, Xiao F, Zeng J. · · 2026 · PMID 42050386 · DOI 10.1111/acel.70527

Verify or expand the search:

Other recruiting trials for Generalized Pustular Psoriasis

Currently open trials in the same condition.

Other Vanda Pharmaceuticals trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing