A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis (POPLAR)

Vanda Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Palmoplantar Pustulosis

Treatments: Biological: Imsidolimab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03633396

ANB019-003

2017-004022-15 (EudraCT Number)

Details and patient eligibility

About

A study to evaluate the efficacy and safety, and pharmacokinetic (PK) profile of multiple doses of imsidolimab (ANB019) in adults with palmoplantar pustulosis (PPP)

Enrollment: 59 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically confirmed diagnosis of PPP
• Disease duration of at least 6 months prior to screening
• Present with active pustules on palms or/and soles at screening

Exclusion criteria

• Any other ongoing inflammatory disease that interfere with the investigator's ability to evaluate the subject's response to therapy
• History of recurrent or active/serious infection
• Ongoing use of psoriasis prohibited medication

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive placebo administered by subcutaneous injection on Day 1 followed by monthly doses of placebo by subcutaneous injection on Days 29, 57, and 85.

Treatment:

Drug: Placebo

imsidolimab

Experimental group

Description:

Participants will receive 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection on Days 29, 57, and 85.

Treatment:

Biological: Imsidolimab