Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement (IMMprint)

IMMprint: A Phase 3b Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study Evaluating Safety and Efficacy of Risankizumab Compared to Placebo in Adult Subjects With Moderate to Severe Plaque Psoriasis With Palmoplantar (Non-Pustular) Involvement (PPPsO)

Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. Palmoplantar (non-pustular) plaque psoriasis (PPPsO) represents a localized form of psoriasis in palms and soles. This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis with palmoplantar involvement and to assess change in disease symptoms.

Risankizumab is an approved drug for the treatment of psoriasis. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo in Period A. In Period B, all the participants will receive risankizumab. Around 168 adult participants with a moderate to severe plaque psoriasis will be enrolled in approximately 55 sites across the world.

Participants will receive single subcutaneous (administered under the skin) risankizumab or placebo in period A (16 weeks). In period B (36 weeks), all participants will receive subcutaneous risankizumab once every 12 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Risankizumab; Drug: Placebo for Risankizumab

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3E 0B2
      • Beacon Dermatology Inc /ID# 220940
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-ho Hong Medical Inc. /ID# 220941
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Dr. Irina Turchin PC Inc. /ID# 220938
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1C 2H5
      • NewLab Clinical Research Inc. /ID# 220934
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Dr. S.K. Siddha Medicine Professional Corporation /ID# 220936
    • Toronto, Ontario, Canada, M4W 2N4
      • Research Toronto /ID# 220939
  • Quebec
    • Montréal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc. /ID# 222126
    • Québec, Quebec, Canada, G1V 4X7
      • Centre de Recherche dermatologique du Quebec Metropolitain /ID# 220935
• Puerto Rico
  • Caguas, Puerto Rico, 00727
    • Dr. Samuel Sanchez PSC /ID# 218789
  • Carolina, Puerto Rico, 00985
    • Cruz-Santana, Carolina, PR /ID# 218790
  • Rio Piedras, Puerto Rico, 00935
    • Pan American Center for Oncology Trials, LLC /ID# 218788
  • San Juan, Puerto Rico, 00909
    • Clinical Research Puerto Rico /ID# 218787
  • San Juan, Puerto Rico, 00909
    • GCM Medical Group, PSC /ID# 218786
• Spain
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa /ID# 224911
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal /ID# 220908
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 220907
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia /ID# 220898
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe /ID# 220903
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa /ID# 222492
  • Malaga
    • Málaga, Malaga, Spain, 29010
      • Hospital Regional de Malaga /ID# 220900
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital Universitario Basurto /ID# 220904
• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Advanced Research Associates - Glendale /ID# 219197
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913-6404
      • Burke Pharmaceutical Research /ID# 223349
    • Rogers, Arkansas, United States, 72758
      • NW Arkansas Clinical Trials Center /ID# 231602
  • California
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates /ID# 219195
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research /ID# 219216
    • San Diego, California, United States, 92103
      • Medderm Associates /ID# 219210
  • Colorado
    • Centennial, Colorado, United States, 80111-1724
      • Colorado Center for Dermatology, PLLC /ID# 219223
  • Florida
    • Hollywood, Florida, United States, 33021-6748
      • Skin Care Research - Hollywood /ID# 219184
    • Margate, Florida, United States, 33063
      • GSI Clinical Research, LLC /ID# 219175
    • Miami Lakes, Florida, United States, 33014-2490
      • Savin Medical Group, LLC /ID# 227754
    • Sweetwater, Florida, United States, 33172
      • Lenus Research & Medical Group /ID# 219202
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Hamilton Research, LLC /ID# 219224
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology /ID# 219211
    • Skokie, Illinois, United States, 60077
      • Northshore University Health System Dermatology Clinical Trials Unit /ID# 219220
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin, LLC /ID# 219219
    • New Albany, Indiana, United States, 47150
      • The Dermatology Center PSC - New Albany /ID# 219183
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Epiphany Dermatology of Kansas LLC /ID# 219208
  • Massachusetts
    • Methuen, Massachusetts, United States, 01844-5864
      • Allcutis Research LLC /ID# 222272
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • David Fivenson, MD, PLC /ID# 219180
    • Detroit, Michigan, United States, 48202-3046
      • Henry Ford Medical Center /ID# 219205
  • Nebraska
    • Omaha, Nebraska, United States, 68144-1105
      • Advanced Dermatology of the Midlands /ID# 219207
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central New Jersey /ID# 219201
  • New York
    • Kew Gardens, New York, United States, 11415
      • Forest Hills Dermatology Group /ID# 219200
    • New York, New York, United States, 10029-6504
      • Icahn School of Medicine at Mount Sinai /ID# 219206
  • Ohio
    • Columbus, Ohio, United States, 43213-4440
      • ClinOhio Research Services /ID# 222298
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh MC /ID# 219203
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886-1617
      • Velocity Clinical Research-Providence /ID# 223350
  • South Carolina
    • Fountain Inn, South Carolina, United States, 29644-1928
      • Palmetto Clinical Trial Services /ID# 222275
    • Fountain Inn, South Carolina, United States, 29644-1928
      • Palmetto Clinical Trial Services /ID# 222299
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130-2450
      • International Clinical Research - Tennessee LLC /ID# 220930
  • Texas
    • Dallas, Texas, United States, 75246
      • Menter Dermatology Res Inst /ID# 219161
    • Houston, Texas, United States, 77004-8097
      • Center for Clinical Studies - Houston (Binz) /ID# 219221
  • Utah
    • Salt Lake City, Utah, United States, 84117-4209
      • Advanced Clinical Research - Woseth Dermatology /ID# 224750
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc. /ID# 219181

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of chronic palmoplantar plaque psoriasis (PPPsO) (with or without psoriatic arthritis) for at least 6 months before Baseline and a Palmoplantar Investigator's Global Assessment (ppIGA) of moderate or severe, at Screening and Baseline.
• Must have at Screening and Baseline a plaque psoriasis (PsO) body surface area (BSA) involvement of greater than or equal to one percent, an Static Physician's Global Assessment (sPGA) score of moderate to severe (greater than or equal to three), a PPASI moderate to severe (greater than or equal to eight), at least one additional PsO plaque outside of the palms and soles.
• Must be a candidate for systemic therapy as assessed by the investigator.
• Previously had inadequately controlled disease by topicals, phototherapy and/or systemic treatments.

Exclusion Criteria:

• History of PsO other than chronic plaque type PsO
• History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.
• Ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with PsO assessments.
• Evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV), Active tuberculosis, Active systemic infection/clinically important infections in the last two weeks prior to Baseline.
• Prior exposure to risankizumab.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Risankizumab; Participants will receive risankizumab for 52 weeks	Drug: Risankizumab; Subcutaneous (SC) Injection; Other Names: ABBV-066; SKYRIZI
Placebo Comparator: Placebo; Participants will receive placebo for 16 weeks followed by risankizumab for 36 weeks.	Drug: Risankizumab; Subcutaneous (SC) Injection; Other Names: ABBV-066; SKYRIZI; Drug: Placebo for Risankizumab; Subcutaneous (SC) Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) of "clear" or "almost clear" (0 or 1) with at least a 2 point reduction from Baseline	The ppIGA is a 5 point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), and scaling of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being "clear" and 1 being "almost clear."	Baseline (Week 0) through Week 16
Number of Participants with Adverse Events	Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 20 weeks after last dose of study drug.	Baseline (Week 0) through 20 weeks after last dose of study drug (Up to 60 weeks total)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving >= 75% improvement in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) response	PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72.	Baseline (Week 0) through Week 16
Percentage of Participants Achieving >= 90% improvement in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) response	PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72.	Baseline (Week 0) through Week 16
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of "clear" or "almost clear" (0 or 1) with at least a 2 point reduction from Baseline	sPGA is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.	Baseline (Week 0) through Week 16
Percentage of Participants Achieving 100% improvement in Palmoplantar Psoriasis Area and Severity Index (PPASI 100) response	PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72.	Baseline (Week 0) through Week 16

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Actual): April 20, 2023
• Study Completion (Actual): April 20, 2023

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Psoriasis; Plaque Psoriasis; Risankizumab; ABBV-066; Moderate to Severe Plaque Psoriasis; SKYRIZI; Plaque Psoriasis with Palmoplantar (Non-Pustular) Involvement (PPPsO)
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: M15-994; 2020-000581-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes