Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP (GEMINI1)

Vanda Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Generalized Pustular Psoriasis

Treatments: Other: Placebo; Drug: Imsidolimab low dose; Drug: Imsidolimab high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT05352893

ANB019-301

Details and patient eligibility

About

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).

Full description

This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.

Enrollment: 45 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Subject has a BSA affected with pustules (excluding palms and soles) ≥ 5%, a GPPPGA score ≥ 3 (moderate severity), and a PRS score ≥ 3 (moderate severity) at Day 1

Exclusion criteria

• Subject has other form of psoriasis excluding psoriasis vulgaris
• Subject flare is so severe that patient's life is at risk

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups, including a placebo group

IV high dose Imsidolimab, other name ANB019

Experimental group

Description:

ANB019 Biological Humanized Monoclonal Antibody High Dose

Treatment:

Drug: Imsidolimab high dose

IV low dose Imsidolimab, other name ANB019

Experimental group

Description:

ANB019 Biological Humanized Monoclonal Antibody Low Dose

Treatment:

Drug: Imsidolimab low dose

IV Placebo

Placebo Comparator group

Description:

Placebo Solution

Treatment:

Other: Placebo