A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis

The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.

Study Overview

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

Detailed Description

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of risankizumab 150 mg/mL formulation in PFS in adult participants with moderate to severe plaque psoriasis. The study included a 30-day screening period, a 28-week treatment period with study visits at Weeks 0, 4, 16 and 28, and a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug. Study drug dosing consisted of 3 self-administered, subcutaneous (SC) doses on Weeks 0, 4, and 16. Dosing on Week 4 was self-administered at home.

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Caguas, Puerto Rico, 00727
    • Dr. Samuel Sanchez, PSC /ID# 211142
  • Rio Piedras, Puerto Rico, 00935
    • Pan American Center for Oncology Trials, LLC /ID# 212445
  • San Juan, Puerto Rico, 0090
    • Clinical Research Puerto Rico /ID# 211144
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Derm Ctr /ID# 210366
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Alliance Dermatology and MOHs /ID# 210645
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Hull Dermatology, PA /ID# 210305
  • California
    • Anaheim, California, United States, 92801-2658
      • Anaheim Clinical Trials LLC /ID# 212559
    • Beverly Hills, California, United States, 90211
      • Wallace Medical Group, Inc. /ID# 210403
    • Los Angeles, California, United States, 90045
      • Dermatology Res. Assoc., CA /ID# 210402
    • Sacramento, California, United States, 95815-4500
      • Integrative Skin Science and Research /ID# 212551
    • Santa Monica, California, United States, 90404
      • Mosaic Dermatology /ID# 210780
  • Florida
    • Boca Raton, Florida, United States, 33486-2269
      • Skin Care Research, LLC /ID# 210514
    • DeLand, Florida, United States, 32720
      • ACCEL Research Sites /ID# 212709
    • Lake City, Florida, United States, 32055-8835
      • Multi-Speciality Research Associates /ID# 211625
    • Margate, Florida, United States, 33063
      • GSI Clinical Research, LLC /ID# 210330
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research /ID# 210874
    • Ormond Beach, Florida, United States, 32174-6302
      • Ormond Medical Arts Pharmaceutical Research Center /ID# 212781
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research /ID# 210877
    • Sunrise, Florida, United States, 33351-7311
      • Precision Clinical Research /ID# 212921
    • Sweetwater, Florida, United States, 33172
      • Lenus Research & Medical Group /ID# 212584
  • Idaho
    • Boise, Idaho, United States, 83713-0997
      • Treasure Valley Dermatology /ID# 212707
  • Illinois
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze, & Itch Associates, LLC /ID# 212562
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center /ID# 210205
  • Kentucky
    • Louisville, Kentucky, United States, 40202-2862
      • Forefront Dermatology /ID# 210520
    • Louisville, Kentucky, United States, 40241-6162
      • DS Research /ID# 210272
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • David Fivenson, MD, PLC /ID# 210193
    • Clarkston, Michigan, United States, 48346
      • Clarkston Skin Research /ID# 210197
    • Detroit, Michigan, United States, 48202-3046
      • Henry Ford Medical Center /ID# 211598
  • Missouri
    • Kirksville, Missouri, United States, 63501-5362
      • Cleaver Dermatology /ID# 210300
  • Nebraska
    • Omaha, Nebraska, United States, 68144-1105
      • Advanced Dermatology of the Midlands /ID# 212763
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC /ID# 211490
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Ctr NJ /ID# 210837
    • Hackensack, New Jersey, United States, 07601-1997
      • Skin Laser and Surgery Specialists of NY and NJ /ID# 210208
  • New York
    • Stony Brook, New York, United States, 11790
      • DermResearchCenter of NY, Inc. /ID# 210652
  • North Carolina
    • Wilmington, North Carolina, United States, 28403
      • WDC Cosmetic and Research, PLLC /ID# 210372
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute (LHSI) /ID# 213216
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC /ID# 210642
  • South Carolina
    • Fountain Inn, South Carolina, United States, 29644-1928
      • Palmetto Clinical Trial Services /ID# 210368
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Ctr /ID# 213069
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc /ID# 210344
    • Houston, Texas, United States, 77004-8097
      • Center for Clinical Studies - Houston (Binz) /ID# 210361
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research /ID# 210359
    • Sugar Land, Texas, United States, 77479-2645
      • Acclaim Dermatology /ID# 212252

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit.
• Participant meets following disease activity criteria:
• Stable moderate to severe chronic plaque psoriasis, defined as greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 12 at Screening and baseline visit.
• Candidate for systemic therapy as assessed by the investigator.

Exclusion Criteria:

• Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis.
• Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
• Participant has previous 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; Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16	Drug: Risankizumab; Risankizumab 150 mg (150 mg/mL) in prefilled syringes, self-administered subcutaneously; Other Names: BI 655066; ABBV-066
Placebo Comparator: Placebo; Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16	Drug: Placebo solution for risankizumab; Placebo solution in prefilled syringes, self-administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16	The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.	At Week 16
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16	The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100.	At Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16	The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100.	At Week 16
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear at Week 16	The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.	At Week 16

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16	The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked.The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Negative values indicate an improvement from baseline.	Baseline, Week 4, and Week 16

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General Publications

• Blauvelt A, Gordon KB, Lee P, Bagel J, Sofen H, Lockshin B, Soliman AM, Geng Z, Zhan T, Alperovich G, Stein Gold L. Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis. J Dermatolog Treat. 2022 Jun;33(4):2085-2093. doi: 10.1080/09546634.2021.1914812. Epub 2021 May 5.

Helpful Links

• Related Info.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Actual): February 20, 2020
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: February 19, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Psoriasis; Plaque Psoriasis; Risankizumab
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: M15-999

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 and 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: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• 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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (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