A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis
- Conditions
- Palmoplantar Pustulosis
- Interventions
- Drug: PlaceboBiological: Imsidolimab
- Registration Number
- NCT03633396
- Lead Sponsor
- AnaptysBio, Inc.
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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. imsidolimab 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI) Baseline to Week 16 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) From first dose of any study drug to Week 24 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
Name Time Method Percentage of Participants Who Achieved 50% Reduction (Improvement) From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index Score (PPPASI 50) Baseline to Week 16 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 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.
Trial Locations
- Locations (41)
Riverchase Dermatology and Cosmetic Surgery
馃嚭馃嚫Pembroke Pines, Florida, United States
University of Alabama at Birmingham
馃嚭馃嚫Birmingham, Alabama, United States
T. Joseph Raoof, MD, Inc.
馃嚭馃嚫Encino, California, United States
Clinical Science Institute
馃嚭馃嚫Santa Monica, California, United States
Next Phase Research Alliance
馃嚭馃嚫Fort Lauderdale, Florida, United States
Ivetmar Medical Group, LLC
馃嚭馃嚫Miami, Florida, United States
Advanced Clinical Research Institute
馃嚭馃嚫Tampa, Florida, United States
DFCRG
馃嚭馃嚫Indianapolis, Indiana, United States
University of Michigan
馃嚭馃嚫Ann Arbor, Michigan, United States
Washington University
馃嚭馃嚫Saint Louis, Missouri, United States
Central Dermatology
馃嚭馃嚫Saint Louis, Missouri, United States
WDC Cosmetic and Research PLLC
馃嚭馃嚫Wilmington, North Carolina, United States
Ohio State University
馃嚭馃嚫Columbus, Ohio, United States
Central Sooner Research
馃嚭馃嚫Norman, Oklahoma, United States
Oregon Health & Science University (OHSU)
馃嚭馃嚫Portland, Oregon, United States
Oregon Health & Science University
馃嚭馃嚫Portland, Oregon, United States
Dermatology Treatment and Research Center
馃嚭馃嚫Dallas, Texas, United States
Medicor Research, Inc.
馃嚚馃嚘Sudbury, Ontario, Canada
Dr. Isabelle Delorme, Inc.
馃嚚馃嚘Drummondville, Quebec, Canada
Innovaderm Research, Inc.
馃嚚馃嚘Montr茅al, Quebec, Canada
Fachklinik Bad Bentheim, Dermatologisches Studienambulanz
馃嚛馃嚜Bad Bentheim, Germany
Klinische Forschung Berlin-Mitte GmbH
馃嚛馃嚜Berlin, Germany
ISA - Interdisciplinary Study Association GmbH
馃嚛馃嚜Berlin, Germany
Universit盲tsklinikum Bonn
馃嚛馃嚜Bonn, Germany
Klinische Forschung Hamburg GmbH
馃嚛馃嚜Hamburg, Germany
Klinische Forschung Schwerin GmbH
馃嚛馃嚜Schwerin, Germany
Mensing Derma Research GmbH
馃嚛馃嚜Hamburg, Germany
Provita Sp. z o. o. Centrum Medyczne Angelius Provita
馃嚨馃嚤Katowice, Poland
Klinika Dermatologii, Chor贸b Przenoszonych Drog膮 P艂ciow膮 i Immunologii Klinicznej
馃嚨馃嚤Olsztyn, Poland
Centrum Bada艅 Klinicznych PI-HOUSE Sp. z o. o.
馃嚨馃嚤Gda艅sk, Poland
Dermedic Jacek Zdybski
馃嚨馃嚤Ostrowiec 艢wi臋tokrzyski, Poland
Laser Clinic s.c. Andrzej Kr贸licki, Tomasz Kochanowski
馃嚨馃嚤Szczecin, Poland
"DERMED" CENTRUM MEDYCZNE SP. z o.o.
馃嚨馃嚤艁贸d藕, Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Sp贸艂ka Partnerska
馃嚨馃嚤Wroc艂aw, Poland
Kansas City Dermatology
馃嚭馃嚫Overland Park, Kansas, United States
Lynderm Research Inc.
馃嚚馃嚘Markham, Ontario, Canada
Dr. Chin-ho Hong Medical, Inc.
馃嚚馃嚘Surrey, British Columbia, Canada
Dr. David Gratton Dermalogue, Inc.
馃嚚馃嚘Montr茅al, Quebec, Canada
Kliniczny Szpital Wojew贸dzki nr 1, Klinika Dermatologii
馃嚨馃嚤Rzesz贸w, Poland
Alliance Dermatology & MOHS Center, PC
馃嚭馃嚫Phoenix, Arizona, United States
The Indiana Clinical Trials Center
馃嚭馃嚫Plainfield, Indiana, United States