Back to resultsA Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis (POPLAR)
Primary Purpose
Palmoplantar Pustulosis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Imsidolimab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Palmoplantar Pustulosis focused on measuring PPP
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham
- Alliance Dermatology & MOHS Center, PC
- T. Joseph Raoof, MD, Inc.
- Clinical Science Institute
- Next Phase Research Alliance
- Ivetmar Medical Group, LLC
- Riverchase Dermatology and Cosmetic Surgery
- Advanced Clinical Research Institute
- DFCRG
- The Indiana Clinical Trials Center
- Kansas City Dermatology
- University of Michigan
- Washington University
- Central Dermatology
- WDC Cosmetic and Research PLLC
- Ohio State University
- Central Sooner Research
- Oregon Health & Science University (OHSU)
- Oregon Health & Science University
- Dermatology Treatment and Research Center
- Dr. Chin-ho Hong Medical, Inc.
- Lynderm Research Inc.
- Medicor Research, Inc.
- Dr. Isabelle Delorme, Inc.
- Dr. David Gratton Dermalogue, Inc.
- Innovaderm Research, Inc.
- Fachklinik Bad Bentheim, Dermatologisches Studienambulanz
- Klinische Forschung Berlin-Mitte GmbH
- ISA - Interdisciplinary Study Association GmbH
- Universitätsklinikum Bonn
- Klinische Forschung Hamburg GmbH
- Mensing Derma Research GmbH
- Klinische Forschung Schwerin GmbH
- Centrum Badań Klinicznych PI-HOUSE Sp. z o. o.
- Provita Sp. z o. o. Centrum Medyczne Angelius Provita
- Klinika Dermatologii, Chorób Przenoszonych Drogą Płciową i Immunologii Klinicznej
- Dermedic Jacek Zdybski
- Kliniczny Szpital Wojewódzki nr 1, Klinika Dermatologii
- Laser Clinic s.c. Andrzej Królicki, Tomasz Kochanowski
- Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
- "DERMED" CENTRUM MEDYCZNE SP. z o.o.
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
imsidolimab
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03633396
Brief Title
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
April 23, 2021 (Actual)
Study Completion Date
April 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AnaptysBio, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palmoplantar Pustulosis
Keywords
PPP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
imsidolimab
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Imsidolimab
Other Intervention Name(s)
ANB019
Intervention Description
Administered by subcutaneous injection once a month
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered by subcutaneous injection once a month
Primary Outcome Measure Information:
Title
Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI)
Description
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.
Time Frame
Baseline to Week 16
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
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.
Time Frame
From first dose of any study drug to Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved 50% Reduction (Improvement) From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index Score (PPPASI 50)
Description
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.
Time Frame
Baseline to Week 16
Title
Percentage of Participants Who Achieved a Clear or Almost Clear Palmoplantar Pustulosis Investigator's Global Assessment (PPPIGA) Score at Week 16
Description
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.
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Randazzo, MD
Organizational Affiliation
AnaptysBio, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Alliance Dermatology & MOHS Center, PC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
T. Joseph Raoof, MD, Inc.
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90405
Country
United States
Facility Name
Next Phase Research Alliance
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Ivetmar Medical Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Riverchase Dermatology and Cosmetic Surgery
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
DFCRG
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Kansas City Dermatology
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Central Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
WDC Cosmetic and Research PLLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Oregon Health & Science University (OHSU)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Dermatology Treatment and Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Dr. Chin-ho Hong Medical, Inc.
City
Surrey
State/Province
British Columbia
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
Country
Canada
Facility Name
Medicor Research, Inc.
City
Sudbury
State/Province
Ontario
Country
Canada
Facility Name
Dr. Isabelle Delorme, Inc.
City
Drummondville
State/Province
Quebec
Country
Canada
Facility Name
Dr. David Gratton Dermalogue, Inc.
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Innovaderm Research, Inc.
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Fachklinik Bad Bentheim, Dermatologisches Studienambulanz
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Klinische Forschung Berlin-Mitte GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
ISA - Interdisciplinary Study Association GmbH
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Klinische Forschung Hamburg GmbH
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Mensing Derma Research GmbH
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Klinische Forschung Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Centrum Badań Klinicznych PI-HOUSE Sp. z o. o.
City
Gdańsk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Provita Sp. z o. o. Centrum Medyczne Angelius Provita
City
Katowice
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Klinika Dermatologii, Chorób Przenoszonych Drogą Płciową i Immunologii Klinicznej
City
Olsztyn
ZIP/Postal Code
10-229
Country
Poland
Facility Name
Dermedic Jacek Zdybski
City
Ostrowiec Świętokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Kliniczny Szpital Wojewódzki nr 1, Klinika Dermatologii
City
Rzeszów
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Laser Clinic s.c. Andrzej Królicki, Tomasz Kochanowski
City
Szczecin
ZIP/Postal Code
70-332
Country
Poland
Facility Name
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
City
Wrocław
ZIP/Postal Code
50-566
Country
Poland
Facility Name
"DERMED" CENTRUM MEDYCZNE SP. z o.o.
City
Łódź
ZIP/Postal Code
90-265
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.anaptysbio.com
Description
Related Information
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis
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