A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis (GPP)

Vanda Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Generalized Pustular Psoriasis

Treatments: Biological: Imsidolimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03619902

2017-004021-33 (EudraCT Number)

ANB019-002

Details and patient eligibility

About

The main objectives of this study are to evaluate the efficacy, safety and tolerability of imsidolimab in adults with active GPP.

Full description

Single arm, multiple-dose study evaluating the use of imsidolimab for the treatment of GPP.

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of active GPP
• Japanese Dermatology Association (JDA) severity index total score of at least 6 and erythema with pustules accounting for at least 10% of body surface area or a moderate severity score on Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA)
• Must be candidates for systemic therapy or phototherapy

Exclusion criteria

• Erythrodermic, guttate psoriasis, drug induced GPP
• Any other ongoing inflammatory disease that interfere with the Investigator's ability to evaluate the subject's response to therapy
• History of recurrent or chronic infection
• ongoing use of psoriasis prohibited medication

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

Imsidolimab

Experimental group

Description:

Participants received imsidolimab 750 mg intravenously (IV) on Day 1 followed by administration of 3 doses of subcutaneous (SC) imsidolimab 100 mg on Days 29, 57, and 85.

Treatment:

Biological: Imsidolimab