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

NCT03633396 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: ANB019-0032017-004022-15
• Study Type: interventional
• Target: 59
• Locations: 4 countries
• Sites: 39

Brief Summary

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

Conditions

Palmoplantar Pustulosis

Keywords

PPP

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI)

  The Palmoplantar Pustulosis Area and Severity Index (PPPASI) is used to assess the severity of palmoplantar pustulosis lesions and their response to therapy. The glabrous skin of both palms and both soles are assessed for erythema, pustules, and desquamation (scaling), each on a scale from 0 (none) to 4 (very severe). The area affected of each palm and sole is scored from 0 (0%) to 6 (90-100%). Scores for the 3 characteristics of PPP are summed and adjusted for the area affected, and the scores for each palm and sole are added to calculate the total score. The PPPASI total score ranges from 0 to 72. A higher score indicates more severe disease, and a negative change from Baseline indicates improvement.

  Baseline to Week 16

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Clinical safety was evaluated by reporting incidence of adverse events up to week 24. TEAEs are defined as new events that occured during or after first dose of study drug or any event that worsens after first dose of study drug. A serious AE (SAE) is defined as any untoward medical occurrence that resulted in death, was life-threatening, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or an important medical event that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above. Severity was assessed by the Investigator as mild (easily tolerated, causing minimal discomfort and not interfering with everyday activities), moderate (causes sufficient discomfort and interferes with normal everyday activities) or severe (prevents normal everyday activities). The Investigator assessed the relationship between study treatment and each AE based on clinical judgement.

  From first dose of any study drug to Week 24

Secondary Outcomes (2)

• Percentage of Participants Who Achieved 50% Reduction (Improvement) From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index Score (PPPASI 50)

  Baseline to Week 16

• Percentage of Participants Who Achieved a Clear or Almost Clear Palmoplantar Pustulosis Investigator's Global Assessment (PPPIGA) Score at Week 16

  Week 16

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

imsidolimab

EXPERIMENTAL

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

Interventions

Imsidolimab BIOLOGICAL

Administered by subcutaneous injection once a month

Also known as: ANB019

imsidolimab

Placebo DRUG

Administered by subcutaneous injection once a month

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (39)

Investigational Site

Birmingham, Alabama, 35233, United States

Location

Investigational Site

Phoenix, Arizona, 85032, United States

Location

Investigational Site

Encino, California, 91436, United States

Location

Investigational Site

Santa Monica, California, 90405, United States

Location

Investigational Site

Fort Lauderdale, Florida, 33316, United States

Location

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Miami, Florida, 33155, United States

Location

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Pembroke Pines, Florida, 33028, United States

Location

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Tampa, Florida, 33607, United States

Location

Investigational Site

Indianapolis, Indiana, 46250, United States

Location

Investigational Site

Plainfield, Indiana, 46168, United States

Location

Investigational Site

Overland Park, Kansas, 66215, United States

Location

Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Investigational Site

St Louis, Missouri, 63110, United States

Location

Investigational Site

St Louis, Missouri, 63117, United States

Location

Investigational Site

Wilmington, North Carolina, 28405, United States

Location

Investigational Site

Columbus, Ohio, 43230, United States

Location

Investigational Site

Norman, Oklahoma, 73071, United States

Location

Investigational Site

Portland, Oregon, 97239, United States

Location

Investigational Site

Dallas, Texas, 75230, United States

Location

Investigational Site

Surrey, British Columbia, Canada

Location

Investigational Site

Greater Sudbury, Ontario, Canada

Location

Investigational Site

Markham, Ontario, Canada

Location

Investigational Site

Drummondville, Quebec, Canada

Location

Investigational Site

Montreal, Quebec, Canada

Location

Investigational Site

Bad Bentheim, 48455, Germany

Location

Investigational Site

Berlin, 10117, Germany

Location

Investigational Site

Berlin, 10789, Germany

Location

Investigational Site

Bonn, 53127, Germany

Location

Investigational Site

Hamburg, 20253, Germany

Location

Investigational Site

Hamburg, 22391, Germany

Location

Investigational Site

Schwerin, 19055, Germany

Location

Investigational Site

Gdansk, 80-546, Poland

Location

Investigational Site

Katowice, 40-611, Poland

Location

Investigational Site

Lodz, 90-265, Poland

Location

Investigational Site

Olsztyn, 10-229, Poland

Location

Investigational Site

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Investigational Site

Rzeszów, 35-055, Poland

Location

Investigational Site

Szczecin, 70-332, Poland

Location

Investigational Site

Wroclaw, 50-566, Poland

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Vanda Pharmaceuticals
• Organization: Vanda Pharmaceuticals

clinicaltrials@vandapharma.com

202-734-3400

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 16, 2018
• Study Start: May 20, 2019
• Primary Completion: April 23, 2021
• Study Completion: April 23, 2021
• Last Updated: September 15, 2025
• Results First Posted: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5); DE (7); US (19); PL (8)