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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Years - 17 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04435600
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	AbbVie
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	ABBVIE INC.
Principal Investigator Affiliation	AbbVie
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, Germany, Japan, Poland, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Psoriasis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Part 1: Risankizumab Dose A

Participants age 12 to less than 18 receive fixed dose of risankizumab Dose A for 40 weeks.

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.

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).

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.

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).

Interventions

Drug: - Risankizumab

Subcutaneous Injection

Drug: - Ustekinumab

Subcutaneous Injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Recruiting

Address

UAB Department of Dermatology /ID# 218834

Birmingham, Alabama, 35233

Site Contact

Site Coordinator

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