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Completed

NCT Number: NCT04435600

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Duplicate_Dermatology Research Institute Inc. /ID# 226172, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Risankizumab

Drug

Subcutaneous Injection

Other names: SKYRIZI, ABBV-066

Ustekinumab

Drug

Subcutaneous Injection

Primary outcomes

  1. Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)

    Time frame: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

    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 the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 75% improvement in PASI.

  2. Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1)

    Time frame: At Week 16 of initial treatment in each part of the study (Parts 1-4)

    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) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).

  3. Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline

    Time frame: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

    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) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).

Secondary outcomes

  1. Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)

    Time frame: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

    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 the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 90% improvement in PASI.

  2. Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)

    Time frame: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

    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 the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 100% improvement in PASI.

  3. Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1)

    Time frame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

    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) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).

  4. Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline

    Time frame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

    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) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).

  5. Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)

    Time frame: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

    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 the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 50% improvement in PASI.

  6. Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)

    Time frame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

    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 the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 50% improvement in PASI.

  7. Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)

    Time frame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

    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 the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 90% improvement in PASI.

  8. Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)

    Time frame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

    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 the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 100% improvement in PASI.

  9. Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI)

    Time frame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

    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 the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 75% improvement in PASI.

  10. Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score

    Time frame: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)

    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). The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item was scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.

  11. Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score

    Time frame: Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)

    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). The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item was scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.

  12. Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score

    Time frame: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)

    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 Quality of Life (QOL) of family members. It consists of 10 questions that assess the impact of skin diseases on different aspects of the family member's QOL. Each item was scored on a 4-point scale: 0 = not at all; 1 = a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.

  13. Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score

    Time frame: Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)

    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 Quality of Life (QOL) of family members. It consists of 10 questions that assess the impact of skin diseases on different aspects of the family member's QOL. Each item was scored on a 4-point scale: 0 = not at all; 1 = a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.

  14. Change From Baseline in Itch Numerical Rating Scale (Itch NRS)

    Time frame: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)

    The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. A negative change from baseline indicates less intense itching and better outcomes.

  15. Change From Baseline in Itch Numerical Rating Scale (Itch NRS)

    Time frame: Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)

    The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. A negative change from baseline indicates less intense itching and better outcomes.

  16. Percentage of Participants Achieving >= 4-point Improvement in the Itch Numerical Rating Scale (in Participants With Baseline Score >= 4)

    Time frame: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)

    The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch within a 24-hour recall period. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving >= 4 point improvement in the itch NRS in participants with a baseline itch NRS score of >=4.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: OptIMMize-1

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 17, 2020
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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