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

Purpose

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

Condition

  • Palmoplantar Pustulosis

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Double-blind

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		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.
  • Drug: Placebo
    Administered by subcutaneous injection once a month
Experimental
imsidolimab 		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.
  • Biological: Imsidolimab
    Administered by subcutaneous injection once a month
    Other names:
    • ANB019

More Details

Status
Completed
Sponsor
AnaptysBio, Inc.

Study Contact