Back to resultsA Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms (OptIMMize-1)
Primary Purpose
Psoriasis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Risankizumab
Ustekinumab
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Plaque Psoriasis, Risankizumab, Ustekinumab, Psoriasis, Biologic, ABBV-066, SKYRIZI
Eligibility Criteria
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.
Sites / Locations
- UAB Department of Dermatology /ID# 218834Recruiting
- First OC Dermatology Research Inc /ID# 217733Recruiting
- Integrative Skin Science and Research /ID# 221741Recruiting
- University of California San Diego - Rady Children's Hospital San Diego /ID# 217906Recruiting
- Rybear, Inc /ID# 223164
- Solutions Through Adv Rch /ID# 217936Recruiting
- Olympian Clinical Research- St. Petersburg /ID# 217941Recruiting
- Advanced Clinical Research Institute /ID# 222706Recruiting
- University Dermatology and Vein Clinic, LLC /ID# 222778Recruiting
- Arlington Dermatology /ID# 217472Recruiting
- Skin Cancer and Dermatology Institute (SCDI) /ID# 221738Recruiting
- Forest Hills Dermatology Group /ID# 227941
- Univ Hosp Cleveland /ID# 228483Recruiting
- The Ohio State University /ID# 217808
- Apex Dermatology & Skin Surgery Center /ID# 228537Recruiting
- Vital Prospects Clinical Research Institute, PC /ID# 217960
- Medical University of South Carolina /ID# 217735Recruiting
- Arlington Research Center, Inc /ID# 217471
- West Virginia University Hospitals /ID# 228352Recruiting
- Clinical Investigation Specialist, Inc - Kenosha /ID# 223161
- Medical College of Wisconsin /ID# 240005Recruiting
- Dermatology Research Institute Inc. /ID# 226172Recruiting
- Karma Clinical Trials /ID# 226177Recruiting
- Hospital for Sick Children /ID# 226167Recruiting
- CHU Sainte-Justine /ID# 226170Recruiting
- Universitaetsklinikum Muenster /ID# 225988Recruiting
- Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 226013Recruiting
- Fachklinik Bad Bentheim /ID# 226014Recruiting
- Universitaetsklinikum Bonn /ID# 228880Recruiting
- Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 228881Recruiting
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 225987Recruiting
- Nagoya City University Hospital /ID# 230830Recruiting
- Hiroshima University Hospital /ID# 256162Recruiting
- Mie University Hospital /ID# 230836Recruiting
- Kansai Medical University Hospital /ID# 231215Recruiting
- Teikyo University Hospital /ID# 255188Recruiting
- Tokyo Medical University Hospital /ID# 230575Recruiting
- Dermed Centrum Medyczne Sp. z o.o /ID# 226062
- Dermoklinika Centrum Medyczne s.c. /ID# 226063
- High-Med Przychodnia Specjalistyczna /ID# 226060
- Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 226116
- Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228252
- Hospital Sant Joan de Deu /ID# 225722Recruiting
- Hospital General Universitario Gregorio Maranon /ID# 225721Recruiting
- Hospital Universitario Infanta Leonor /ID# 225720Recruiting
- Hospital Universitario 12 de Octubre /ID# 227860Recruiting
- Complejo Hospitalario Universitario de Pontevedra /ID# 226061Recruiting
- Royal Devon University Healthcare NHS Foundation Trust /ID# 228078Recruiting
- Guys and St Thomas NHS Foundation Trust /ID# 227224Recruiting
- NHS Greater Glasgow and Clyde /ID# 227226
- Frimley Health NHS Foundation Trust /ID# 229525Recruiting
- Chelsea and Westminster Hospital NHS Foundation Trust /ID# 227231Recruiting
- University Hospital Plymouth NHS Trust /ID# 227230Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Part 1: Risankizumab Dose A
Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B
Part 2: Risankizumab Dose A/B
Part 3: Risankizumab Dose A/B
Part 4: Risankizumab Dose A/B
Arm Description
Participants age 12 to less than 18 receive fixed dose of risankizumab Dose A for 40 weeks.
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.
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).
Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks.
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).
Outcomes
Primary Outcome Measures
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.
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).
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).
Secondary Outcome Measures
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.
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.
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.
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).
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).
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.
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.
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.
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.
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).
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.
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.
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.
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."
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."
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."
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04435600
Brief Title
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
Acronym
OptIMMize-1
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
October 11, 2024 (Anticipated)
Study Completion Date
August 7, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Plaque Psoriasis, Risankizumab, Ustekinumab, Psoriasis, Biologic, ABBV-066, SKYRIZI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Part 1: Risankizumab Dose A
Arm Type
Experimental
Arm Description
Participants age 12 to less than 18 receive fixed dose of risankizumab Dose A for 40 weeks.
Arm Title
Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2: Risankizumab Dose A/B
Arm Type
Experimental
Arm Description
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).
Arm Title
Part 3: Risankizumab Dose A/B
Arm Type
Experimental
Arm Description
Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks.
Arm Title
Part 4: Risankizumab Dose A/B
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Risankizumab
Other Intervention Name(s)
SKYRIZI, ABBV-066
Intervention Description
Subcutaneous Injection
Intervention Type
Drug
Intervention Name(s)
Ustekinumab
Intervention Description
Subcutaneous Injection
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)
Description
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.
Time Frame
Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)
Title
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear
Description
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).
Time Frame
At Week 16 of each part of the study (Parts 1-4)
Title
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
Description
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).
Time Frame
At Week 16 of each part of the study (Parts 1-4)
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)
Description
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.
Time Frame
Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)
Title
Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)
Description
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.
Time Frame
Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)
Title
Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)
Description
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.
Time Frame
Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4)
Title
Part 2 (Period C): Percentage of Participants sPGA Clear or Almost Clear
Description
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).
Time Frame
Baseline (Week 0) to Week 16 upon start of re-treatment in Part 2 (Period C)
Title
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
Description
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).
Time Frame
Baseline (Week 0) to Week 16 upon start of re-treatment in Part 2 (Period C)
Title
Part 2 (Period C): Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)
Description
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.
Time Frame
Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
Title
Part 2 (Period C): Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)
Description
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.
Time Frame
Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
Title
Part 2 (Period C): Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)
Description
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.
Time Frame
Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
Title
Part 2 (Period C): Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI)
Description
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.
Time Frame
Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
Title
Part 2 (Period A): Change in Children's Dermatology Life Quality Index (CDLQI)
Description
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).
Time Frame
Baseline (Week 0) to Week 16 in Part 2 (Period A)
Title
Part 2 (Period C): Change in CDLQI
Description
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.
Time Frame
Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
Title
Part 2 (Period A): Change in Family Dermatology Life Quality Index (FDLQI)
Description
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.
Time Frame
Baseline (Week 0) to Week 16 in Part 2 (Period A)
Title
Part 2 (Period C): Change in FDLQI
Description
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.
Time Frame
Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
Title
Part 2 (Period C): Change in Itch Numerical Rating Scale (Itch NRS)
Description
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."
Time Frame
Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
Title
Part 2 (Period C): Change in Itch NRS
Description
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."
Time Frame
Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C)
Title
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
Description
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."
Time Frame
Baseline (Week 0) to Week 16 in Part 2 (Period A)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
UAB Department of Dermatology /ID# 218834
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
First OC Dermatology Research Inc /ID# 217733
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708-3701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Integrative Skin Science and Research /ID# 221741
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
University of California San Diego - Rady Children's Hospital San Diego /ID# 217906
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
Rybear, Inc /ID# 223164
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316-1952
Country
United States
Individual Site Status
Completed
Facility Name
Solutions Through Adv Rch /ID# 217936
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Olympian Clinical Research- St. Petersburg /ID# 217941
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709-1405
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Clinical Research Institute /ID# 222706
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Individual Site Status
Recruiting
Facility Name
University Dermatology and Vein Clinic, LLC /ID# 222778
City
Darien
State/Province
Illinois
ZIP/Postal Code
60561
Country
United States
Individual Site Status
Recruiting
Facility Name
Arlington Dermatology /ID# 217472
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Skin Cancer and Dermatology Institute (SCDI) /ID# 221738
City
Reno
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Forest Hills Dermatology Group /ID# 227941
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Individual Site Status
Completed
Facility Name
Univ Hosp Cleveland /ID# 228483
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University /ID# 217808
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Completed
Facility Name
Apex Dermatology & Skin Surgery Center /ID# 228537
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124-6509
Country
United States
Individual Site Status
Recruiting
Facility Name
Vital Prospects Clinical Research Institute, PC /ID# 217960
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-7049
Country
United States
Individual Site Status
Completed
Facility Name
Medical University of South Carolina /ID# 217735
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Arlington Research Center, Inc /ID# 217471
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Individual Site Status
Completed
Facility Name
West Virginia University Hospitals /ID# 228352
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Investigation Specialist, Inc - Kenosha /ID# 223161
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144-1782
Country
United States
Individual Site Status
Completed
Facility Name
Medical College of Wisconsin /ID# 240005
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3522
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Research Institute Inc. /ID# 226172
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Karma Clinical Trials /ID# 226177
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 4Y3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hospital for Sick Children /ID# 226167
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU Sainte-Justine /ID# 226170
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Muenster /ID# 225988
City
Munster
State/Province
Niedersachsen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 226013
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Fachklinik Bad Bentheim /ID# 226014
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Bonn /ID# 228880
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 228881
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 225987
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Nagoya City University Hospital /ID# 230830
City
Nagoya shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hiroshima University Hospital /ID# 256162
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mie University Hospital /ID# 230836
City
Tsu-shi
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kansai Medical University Hospital /ID# 231215
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Recruiting
Facility Name
Teikyo University Hospital /ID# 255188
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical University Hospital /ID# 230575
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dermed Centrum Medyczne Sp. z o.o /ID# 226062
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-265
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Dermoklinika Centrum Medyczne s.c. /ID# 226063
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-436
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
High-Med Przychodnia Specjalistyczna /ID# 226060
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-817
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 226116
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-055
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228252
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Hospital Sant Joan de Deu /ID# 225722
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 225721
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Infanta Leonor /ID# 225720
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre /ID# 227860
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario de Pontevedra /ID# 226061
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Individual Site Status
Recruiting
Facility Name
Royal Devon University Healthcare NHS Foundation Trust /ID# 228078
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Guys and St Thomas NHS Foundation Trust /ID# 227224
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
NHS Greater Glasgow and Clyde /ID# 227226
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0XH
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Frimley Health NHS Foundation Trust /ID# 229525
City
Camberley
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Chelsea and Westminster Hospital NHS Foundation Trust /ID# 227231
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospital Plymouth NHS Trust /ID# 227230
City
Plymouth
ZIP/Postal Code
PL6 5FP
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M19-977
Description
Related Info
Learn more about this trial
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
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