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

AbbVie

Status and phase: Active, not recruiting; Phase 3

Conditions: Psoriasis

Treatments: Drug: Ustekinumab; Drug: Risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04435600

2023-504156-10-00 (Other Identifier)

M19-977

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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132 participants in 5 patient groups

Part 1: Risankizumab Dose A

Experimental group

Description:

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

Treatment:

Drug: Risankizumab

Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B

Experimental group

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.

Treatment:

Drug: Ustekinumab

Drug: Risankizumab

Part 2: Risankizumab Dose A/B

Experimental group

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).

Treatment:

Drug: Risankizumab

Part 3: Risankizumab Dose A/B

Experimental group

Description:

Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks.

Treatment:

Drug: Risankizumab

Part 4: Risankizumab Dose A/B

Experimental group

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).

Treatment:

Drug: Risankizumab