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

Palmoplantar Pustulosis Clinical Trial

— POPLAR  

Official title:

A Phase 2, Randomized, Placebo-controlled, Double-blind, Multiple Dose Study to Evaluate the Efficacy and Safety of ANB019 in Subjects With Palmoplantar Pustulosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03633396
• Other study ID #: ANB019-003
• Secondary ID: 2017-004022-15
• Status: Completed
• Phase: Phase 2
• Start date: May 20, 2019
• Est. completion date: April 23, 2021

Study information

• Verified date: May 2022
• Source: AnaptysBio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 23, 2021
• Est. primary completion date: April 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Palmoplantar Pustulosis
• Psoriasis

Intervention

Biological:
• Imsidolimab
Administered by subcutaneous injection once a month

Drug:
• Placebo
Administered by subcutaneous injection once a month

Locations

Country	Name	City	State
Canada	Dr. Isabelle Delorme, Inc.	Drummondville	Quebec
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	Dr. David Gratton Dermalogue, Inc.	Montréal	Quebec
Canada	Innovaderm Research, Inc.	Montréal	Quebec
Canada	Medicor Research, Inc.	Sudbury	Ontario
Canada	Dr. Chin-ho Hong Medical, Inc.	Surrey	British Columbia
Germany	Fachklinik Bad Bentheim, Dermatologisches Studienambulanz	Bad Bentheim
Germany	ISA - Interdisciplinary Study Association GmbH	Berlin
Germany	Klinische Forschung Berlin-Mitte GmbH	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	Klinische Forschung Hamburg GmbH	Hamburg
Germany	Mensing Derma Research GmbH	Hamburg
Germany	Klinische Forschung Schwerin GmbH	Schwerin
Poland	Centrum Badan Klinicznych PI-HOUSE Sp. z o. o.	Gdansk
Poland	Provita Sp. z o. o. Centrum Medyczne Angelius Provita	Katowice
Poland	"DERMED" CENTRUM MEDYCZNE SP. z o.o.	Lódz
Poland	Klinika Dermatologii, Chorób Przenoszonych Droga Plciowa i Immunologii Klinicznej	Olsztyn
Poland	Dermedic Jacek Zdybski	Ostrowiec Swietokrzyski
Poland	Kliniczny Szpital Wojewódzki nr 1, Klinika Dermatologii	Rzeszów
Poland	Laser Clinic s.c. Andrzej Królicki, Tomasz Kochanowski	Szczecin
Poland	Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spólka Partnerska	Wroclaw
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Ohio State University	Columbus	Ohio
United States	Dermatology Treatment and Research Center	Dallas	Texas
United States	T. Joseph Raoof, MD, Inc.	Encino	California
United States	Next Phase Research Alliance	Fort Lauderdale	Florida
United States	DFCRG	Indianapolis	Indiana
United States	Ivetmar Medical Group, LLC	Miami	Florida
United States	Central Sooner Research	Norman	Oklahoma
United States	Kansas City Dermatology	Overland Park	Kansas
United States	Riverchase Dermatology and Cosmetic Surgery	Pembroke Pines	Florida
United States	Alliance Dermatology & MOHS Center, PC	Phoenix	Arizona
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	Oregon Health & Science University	Portland	Oregon
United States	Oregon Health & Science University (OHSU)	Portland	Oregon
United States	Central Dermatology	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	Clinical Science Institute	Santa Monica	California
United States	Advanced Clinical Research Institute	Tampa	Florida
United States	WDC Cosmetic and Research PLLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AnaptysBio, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage of Participants Who Achieved 50% Reduction (Improvement) From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index Score (PPPASI 50)	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.	Baseline to Week 16
Secondary	Percentage of Participants Who Achieved a Clear or Almost Clear Palmoplantar Pustulosis Investigator's Global Assessment (PPPIGA) Score at Week 16	The Investigator rated the severity of participants' disease on the following 5-point scale: 0: Clear - No signs of palmoplantar pustulosis; no scaling or crusts or pustules remain; 1: Almost clear - Slight scaling and/or erythema and/or slight crusts; very few (yellow) and/or old (brown) pustules; 2: Mild - Scaling and/or erythema and/or crusts; visible new (yellow) and/or old (brown) pustules of limited number and extent; 3: Moderate - Prominent scaling and/or erythema and/or crusting; prominent new (yellow) and/or old (brown) pustules covering most of the area involved; 4: Severe - Severe scaling and/or erythema and/or crusting; numerous new (yellow) and/or old (brown) pustules with / without major confluence, covering the entire area of at least 2 palmoplantar sites.	Week 16

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