Study to Evaluate the Long-Term Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Subjects With GPP (GEMINI-2)

Vanda Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Generalized Pustular Psoriasis

Treatments: Drug: Double-blind 200 mg imsidolimab; Other: Placebo; Drug: Open-label 200 mg imsidolimab; Other: Standard of Care (SOC); Drug: Imsidolimab 750 mg IV/200 mg SC

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

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42 participants in 8 patient groups, including a placebo group

ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC

Experimental group

Description:

Randomized to subcutaneous 200 mg imsidolimab Q4W

Treatment:

Drug: Double-blind 200 mg imsidolimab

ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC

Placebo Comparator group

Description:

Randomized to subcutaneous placebo Q4W

Treatment:

Other: Placebo

ANB019-301 Imsidolimab Partial Responder + ANB019-302 Imsidolimab 200 mg SC

Experimental group

Description:

Open-label subcutaneous 200 mg imsidolimab Q4W

Treatment:

Drug: Open-label 200 mg imsidolimab

ANB019-301 Imsidolimab Need for Rescue + ANB019-302 Any Therapy

Active Comparator group

Description:

Any available therapy

Treatment:

Other: Standard of Care (SOC)

ANB019-301 Placebo Responder + ANB019-302 Imsidolimab 200 mg SC

Experimental group

Description:

Randomized to subcutaneous 200 mg imsidolimab Q4W

Treatment:

Drug: Double-blind 200 mg imsidolimab

ANB019-301 Placebo Responder + ANB019-302 Placebo SC

Placebo Comparator group

Description:

Randomized to subcutaneous placebo SC Q4W

Treatment:

Other: Placebo

ANB019-301 Placebo Partial Responder + ANB019-302 Imsidolimab 200 mg SC

Experimental group

Description:

Open-label subcutaneous 200 mg imsidolimab Q4W

Treatment:

Drug: Open-label 200 mg imsidolimab

ANB019-301 Placebo Need for Rescue + ANB019-302 Imsidolimab 750 mg IV/200 mg SC

Experimental group

Description:

Intravenous imsidolimab 750 mg loading dose followed by subcutaneous 200 mg imsidolimab Q4W

Treatment:

Drug: Imsidolimab 750 mg IV/200 mg SC