Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis (GEMINI-2)

Vanda Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Generalized Pustular Psoriasis

Treatments: Biological: Imsidolimab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05366855

ANB019-302

Details and patient eligibility

About

This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

Full description

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

Enrollment: 42 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject participated in the preceding placebo-controlled Phase 3 study ANB019-301 and completed at least the Week 1 visit of the ANB019-301 study without the use of rescue/prohibited medication for GPP
• Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment

Exclusion criteria

• Use of prohibited medications between the last visit of the ANB019-301 study and the Day 1 visit of the ANB019-302 study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

42 participants in 4 patient groups, including a placebo group

IV +SC Imsidolimab

Active Comparator group

Description:

IV loading dose followed by subcutaneous Imsidolimab

Treatment:

Biological: Imsidolimab

SC Imsidolimab

Active Comparator group

Description:

Subcutaneous Imsidolimab

Treatment:

Biological: Imsidolimab

SC Placebo

Placebo Comparator group

Description:

Subcutaneous Placebo

Treatment:

Other: Placebo

Standard of Care

No Intervention group

Description:

Any available therapy