A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms (OptIMMize-1)

A Randomized, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients From 6 to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis

Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. There is an unmet medical need for effective treatment in pediatric patients and this study is being done to evaluate risankizumab in pediatric participants with moderate to severe plaque psoriasis. This study will assess the change in disease symptoms.

Risankizumab is a drug being studied for the treatment for plaque psoriasis in pediatric participants. This study has 4 parts.

Part 1: Participants aged 12 < 18 will receive a fixed dose of risankizumab. Part 2: Participants aged 12 < 18 will receive;

• Period A: Risankizumab or ustekinumab based on body weight followed by;
• Period B: Risankizumab or no treatment.
• Period C: Re-treatment with risankizumab (if needed).

Part 3: Participants aged 6 < 12 will receive risankizumab based on body weight.

Part 4: Participants aged 6 < 12 will receive risankizumab based on body weight (Japan only: Participants aged 12 > 18 will receive risankizumab based on body weight).

Around 132 participants will be enrolled in approximately 50 sites worldwide.

Risankizumab and ustekinumab are given as a subcutaneous (under the skin) injection.

Parts 1, 3, and 4: Risankizumab for 40 weeks with a follow-up call 20 weeks later for a study duration of approximately 65 weeks.

Part 2:

• Period A: Risankizumab or ustekinumab for 16 weeks.
• Period B: Risankizumab or no treatment for 36 weeks.
• Period C: Re-treatment with risankizumab for 16 weeks. Follow-up call 20 weeks later for a study duration of approximately 81 weeks. Participants from each Part who meet eligibility criteria for an open-label extension (OLE) study may continue on risankizumab for 216 additional weeks.

There may be a higher burden for study participants compared to standard treatment. Participants will attend monthly visits and medical assessments will check the effect of treatment through blood tests, questionnaires, and checking for side effects.

Study Overview

• Status: Active, not recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Risankizumab; Drug: Ustekinumab

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute Inc. /ID# 226172
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
      • Karma Clinical Trials /ID# 226177
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Hospital for Sick Children /ID# 226167
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • CHU Sainte-Justine /ID# 226170
• Germany
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim /ID# 226014
  • Bonn, Germany, 53127
    • Universitaetsklinikum Bonn /ID# 228880
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 228881
  • Mainz, Germany, 55131
    • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 225987
  • Nordrhein-Westfalen
    • Muenster, Nordrhein-Westfalen, Germany, 48149
      • Universitaetsklinikum Muenster /ID# 225988
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 226013
• Japan
  • Aichi
    • Nagoya shi, Aichi, Japan, 467-8602
      • Nagoya City University Hospital /ID# 230830
  • Hiroshima
    • Hiroshima-shi, Hiroshima, Japan, 734-8551
      • Hiroshima University Hospital /ID# 256162
  • Mie
    • Tsu-shi, Mie, Japan, 514-8507
      • Mie University Hospital /ID# 230836
  • Osaka
    • Hirakata-shi, Osaka, Japan, 573-1191
      • Kansai Medical University Hospital /ID# 231215
  • Tokyo
    • Itabashi-ku, Tokyo, Japan, 173-8606
      • Teikyo University Hospital /ID# 255188
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Tokyo Medical University Hospital /ID# 230575
• Poland
  • Lodzkie
    • Lodz, Lodzkie, Poland, 90-265
      • Dermed Centrum Medyczne Sp. z o.o /ID# 226062
    • Lodz, Lodzkie, Poland, 90-436
      • Dermoklinika Centrum Medyczne s.c. /ID# 226063
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 01-817
      • High-Med Przychodnia Specjalistyczna /ID# 226060
  • Podkarpackie
    • Rzeszow, Podkarpackie, Poland, 35-055
      • Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 226116
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-546
      • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228252
• Spain
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon /ID# 225721
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor /ID# 225720
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre /ID# 227860
  • Pontevedra, Spain, 36071
    • Complejo Hospitalario Universitario de Pontevedra /ID# 226061
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Hospital Sant Joan de Deu /ID# 225722
• United Kingdom
  • London, United Kingdom, SW10 9NH
    • Chelsea and Westminster Hospital NHS Foundation Trust /ID# 227231
  • Plymouth, United Kingdom, PL6 5FP
    • University Hospital Plymouth NHS Trust /ID# 227230
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Devon University Healthcare NHS Foundation Trust /ID# 228078
  • London, City Of
    • London, London, City Of, United Kingdom, SE1 9RT
      • Guys and St Thomas NHS Foundation Trust /ID# 227224
  • Scotland
    • Glasgow, Scotland, United Kingdom, G12 0XH
      • NHS Greater Glasgow and Clyde /ID# 227226
  • Surrey
    • Camberley, Surrey, United Kingdom, GU16 7UJ
      • Frimley Health NHS Foundation Trust /ID# 229525
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Department of Dermatology /ID# 218834
  • California
    • Fountain Valley, California, United States, 92708-3701
      • First OC Dermatology Research Inc /ID# 217733
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research /ID# 221741
    • San Diego, California, United States, 92123
      • University of California San Diego - Rady Children's Hospital San Diego /ID# 217906
  • Florida
    • Fort Lauderdale, Florida, United States, 33316-1952
      • Rybear, Inc /ID# 223164
    • Jacksonville, Florida, United States, 32256
      • Solutions Through Adv Rch /ID# 217936
    • Saint Petersburg, Florida, United States, 33709-1405
      • Olympian Clinical Research- St. Petersburg /ID# 217941
    • Tampa, Florida, United States, 33607
      • Advanced Clinical Research Institute /ID# 222706
  • Illinois
    • Darien, Illinois, United States, 60561
      • University Dermatology and Vein Clinic, LLC /ID# 222778
    • Rolling Meadows, Illinois, United States, 60008
      • Duplicate_Arlington Dermatology /ID# 217472
  • Nevada
    • Reno, Nevada, United States, 89052
      • Skin Cancer and Dermatology Institute (SCDI) /ID# 221738
  • New York
    • Kew Gardens, New York, United States, 11415
      • Forest Hills Dermatology Group /ID# 227941
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Univ Hosp Cleveland /ID# 228483
    • Columbus, Ohio, United States, 43210
      • The Ohio State University /ID# 217808
    • Mayfield Heights, Ohio, United States, 44124-4005
      • Apex Dermatology & Skin Surgery Center /ID# 228537
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136-7049
      • Vital Prospects Clinical Research Institute, PC /ID# 217960
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina /ID# 217735
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc /ID# 217471
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospitals /ID# 228352
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53144-1782
      • Clinical Investigation Specialist, Inc - Kenosha /ID# 223161
    • Milwaukee, Wisconsin, United States, 53226-3522
      • Medical College of Wisconsin /ID# 240005

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of chronic plaque psoriasis for at least 6 months before the Baseline Visit.
• Stable severe or moderate to severe plaque psoriasis as defined in each study part by body surface area (BSA) psoriasis involvement and scores on the Psoriasis Area and Severity Index (PASI) and Static Physician Global Assessment (sPGA).
• Candidate for systemic therapy as assessed by the investigator and meet the disease activity criteria at both the Screening and Baseline Visits per the protocol.

Exclusion Criteria:

- Concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the participant's participation in this study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk by participating in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Risankizumab Dose A; Participants age 12 to less than 18 receive fixed dose of risankizumab Dose A for 40 weeks.	Drug: Risankizumab; Subcutaneous Injection; Other Names: ABBV-066; SKYRIZI
Experimental: Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B; Participants age 12 to less than 18 will receive: Period A: Ustekinumab Dose A, Dose B, or Dose C based on body weight for 16 weeks (at Week 0 and Week 4). Period B: Risankizumab Dose A or B based on body weight for 24 weeks.	Drug: Risankizumab; Subcutaneous Injection; Other Names: ABBV-066; SKYRIZI; Drug: Ustekinumab; Subcutaneous Injection
Experimental: Part 2: Risankizumab Dose A/B; Participants age 12 to less than 18 will receive: Period A: Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4). Period B: Participants who respond to Risankizumab in Period A are re-randomized to continue Risankizumab Dose A or B based on body weight for up to 24 weeks or withdraw from treatment until flare. Period C: Participants withdrawn from treatment in Period B and experience a flare in symptoms at Week 28 or beyond are eligible for re-treatment with Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4).	Drug: Risankizumab; Subcutaneous Injection; Other Names: ABBV-066; SKYRIZI
Experimental: Part 3: Risankizumab Dose A/B; Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks.	Drug: Risankizumab; Subcutaneous Injection; Other Names: ABBV-066; SKYRIZI
Experimental: Part 4: Risankizumab Dose A/B; Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks (Japan only: participants age 12 to less than 18 years will be included).	Drug: Risankizumab; Subcutaneous Injection; Other Names: ABBV-066; SKYRIZI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear	The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).	At Week 16 of each part of the study (Parts 1-4)
US Only: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear and with at least 2 grade improvement from baseline	The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).	At Week 16 of each part of the study (Parts 1-4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)
Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)
Part 2 (Period C): Percentage of Participants sPGA Clear or Almost Clear	The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).	Baseline (Week 0) to Week 16 upon start of re-treatment in Part 2 (Period C)
Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)
Part 2 (Period C): Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
Part 2 (Period C): Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
Part 2 (Period C): Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
Part 2 (Period C): Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI)	The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.	Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
Part 2 (Period A): Change in Children's Dermatology Life Quality Index (CDLQI)	The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on quality of life (QOL).	Baseline (Week 0) to Week 16 in Part 2 (Period A)
Part 2 (Period C): Change in CDLQI	The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on QOL.	Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
Part 2 (Period A): Change in Family Dermatology Life Quality Index (FDLQI)	The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on QOL of family members.	Baseline (Week 0) to Week 16 in Part 2 (Period A)
Part 2 (Period C): Change in FDLQI	The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on QOL of family members.	Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
Part 2 (Period C): Change in Itch NRS	The itch NRS is an 11-points scale that subjects will complete to describe the intensity of their itch using a 24-hour recall period. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable."	Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
Part 2 (Period C): US Only: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear and with at least 2 grade improvement from baseline	The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).	Baseline (Week 0) to Week 16 upon start of re-treatment in Part 2 (Period C)
Part 2 (Period C): Change in Itch Numerical Rating Scale (Itch NRS)	The itch NRS is an 11-points scale that subjects will complete to describe the intensity of their itch using a 24-hour recall period. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable."	Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
Part 2 (Period A): Percentage of Participants Achieving > = 4-point Improvement in the Itch Numerical Rating Scale (in Participants with Baseline Score > = 4) at Each Study Visit	The itch NRS is an 11-points scale that subjects will complete to describe the intensity of their itch using a 24-hour recall period. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable."	Baseline (Week 0) to Week 16 in Part 2 (Period A)

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): July 14, 2020
• Primary Completion (Actual): February 12, 2024
• Study Completion (Estimated): December 16, 2024

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Psoriasis; Biologic; Plaque Psoriasis; Ustekinumab; Risankizumab; ABBV-066; SKYRIZI
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Ustekinumab
• Other Study ID Numbers: M19-977; 2023-504156-10-00 (Other Identifier: EU CT)

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