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

Psoriasis Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04435600
• Other study ID #: M19-977
• Secondary ID: 2023-504156-10-0
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 14, 2020
• Est. completion date: December 16, 2024

Study information

• Verified date: March 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: December 16, 2024
• Est. primary completion date: February 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Risankizumab
Subcutaneous Injection
• Ustekinumab
Subcutaneous Injection

Locations

Country	Name	City	State
Canada	Dermatology Research Institute Inc. /ID# 226172	Calgary	Alberta
Canada	CHU Sainte-Justine /ID# 226170	Montreal	Quebec
Canada	Karma Clinical Trials /ID# 226177	St. John's	Newfoundland and Labrador
Canada	Hospital for Sick Children /ID# 226167	Toronto	Ontario
Germany	Fachklinik Bad Bentheim /ID# 226014	Bad Bentheim
Germany	Universitaetsklinikum Bonn /ID# 228880	Bonn
Germany	Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 228881	Dresden
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 226013	Kiel	Schleswig-Holstein
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 225987	Mainz
Germany	Universitaetsklinikum Muenster /ID# 225988	Muenster	Nordrhein-Westfalen
Japan	Kansai Medical University Hospital /ID# 231215	Hirakata-shi	Osaka
Japan	Hiroshima University Hospital /ID# 256162	Hiroshima-shi	Hiroshima
Japan	Teikyo University Hospital /ID# 255188	Itabashi-ku	Tokyo
Japan	Nagoya City University Hospital /ID# 230830	Nagoya shi	Aichi
Japan	Tokyo Medical University Hospital /ID# 230575	Shinjuku-ku	Tokyo
Japan	Mie University Hospital /ID# 230836	Tsu-shi	Mie
Poland	Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228252	Gdansk	Pomorskie
Poland	Dermed Centrum Medyczne Sp. z o.o /ID# 226062	Lodz	Lodzkie
Poland	Dermoklinika Centrum Medyczne s.c. /ID# 226063	Lodz	Lodzkie
Poland	Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 226116	Rzeszow	Podkarpackie
Poland	High-Med Przychodnia Specjalistyczna /ID# 226060	Warszawa	Mazowieckie
Spain	Hospital Sant Joan de Deu /ID# 225722	Esplugues de Llobregat	Barcelona
Spain	Hospital General Universitario Gregorio Maranon /ID# 225721	Madrid
Spain	Hospital Universitario 12 de Octubre /ID# 227860	Madrid
Spain	Hospital Universitario Infanta Leonor /ID# 225720	Madrid
Spain	Complejo Hospitalario Universitario de Pontevedra /ID# 226061	Pontevedra
United Kingdom	Frimley Health NHS Foundation Trust /ID# 229525	Camberley	Surrey
United Kingdom	Royal Devon University Healthcare NHS Foundation Trust /ID# 228078	Exeter	Devon
United Kingdom	NHS Greater Glasgow and Clyde /ID# 227226	Glasgow	Scotland
United Kingdom	Chelsea and Westminster Hospital NHS Foundation Trust /ID# 227231	London
United Kingdom	Guys and St Thomas NHS Foundation Trust /ID# 227224	London	London, City Of
United Kingdom	University Hospital Plymouth NHS Trust /ID# 227230	Plymouth
United States	Arlington Research Center, Inc /ID# 217471	Arlington	Texas
United States	UAB Department of Dermatology /ID# 218834	Birmingham	Alabama
United States	Medical University of South Carolina /ID# 217735	Charleston	South Carolina
United States	Univ Hosp Cleveland /ID# 228483	Cleveland	Ohio
United States	The Ohio State University /ID# 217808	Columbus	Ohio
United States	University Dermatology and Vein Clinic, LLC /ID# 222778	Darien	Illinois
United States	Rybear, Inc /ID# 223164	Fort Lauderdale	Florida
United States	First OC Dermatology Research Inc /ID# 217733	Fountain Valley	California
United States	Solutions Through Adv Rch /ID# 217936	Jacksonville	Florida
United States	Clinical Investigation Specialist, Inc - Kenosha /ID# 223161	Kenosha	Wisconsin
United States	Forest Hills Dermatology Group /ID# 227941	Kew Gardens	New York
United States	Apex Dermatology & Skin Surgery Center /ID# 228537	Mayfield Heights	Ohio
United States	Medical College of Wisconsin /ID# 240005	Milwaukee	Wisconsin
United States	West Virginia University Hospitals /ID# 228352	Morgantown	West Virginia
United States	Skin Cancer and Dermatology Institute (SCDI) /ID# 221738	Reno	Nevada
United States	Duplicate_Arlington Dermatology /ID# 217472	Rolling Meadows	Illinois
United States	Integrative Skin Science and Research /ID# 221741	Sacramento	California
United States	Olympian Clinical Research- St. Petersburg /ID# 217941	Saint Petersburg	Florida
United States	University of California San Diego - Rady Children's Hospital San Diego /ID# 217906	San Diego	California
United States	Advanced Clinical Research Institute /ID# 222706	Tampa	Florida
United States	Vital Prospects Clinical Research Institute, PC /ID# 217960	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Japan,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

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