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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.