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Monoclonal Antibodies

Risankizumab Injection for Psoriasis (OptIMMize-1 Trial)

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stable severe or moderate to severe plaque psoriasis as defined by body surface area (BSA) psoriasis involvement and scores on the Psoriasis Area and Severity Index (PASI) and Static Physician Global Assessment (sPGA)

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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 16 of each part of the study (parts 1-4)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will assess the change in disease symptoms of pediatric patients with plaque psoriasis after receiving risankizumab. There are four parts to the study, with the last part being an open-label extension for participants who continue to show improvement.

Who is the study for?

This trial is for children and teenagers with moderate to severe plaque psoriasis, a skin condition causing red and scaly patches. Participants must have had psoriasis for at least 6 months, be candidates for systemic therapy, and meet specific disease severity criteria.

What is being tested?

The study tests Risankizumab injections in kids aged 6-18 years with plaque psoriasis. It has four parts: fixed doses or weight-based dosing of Risankizumab alone or compared to Ustekinumab. Some may get no treatment before possible re-treatment with Risankizumab.

What are the potential side effects?

Risankizumab and Ustekinumab might cause injection site reactions, infections due to immune system effects, headaches, fatigue, digestive issues. Side effects vary by individual; the study includes regular check-ups to monitor these.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My psoriasis is stable and covers a significant part of my body.

Select...

My psoriasis is stable and covers a significant part of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 16 of each part of the study (parts 1-4)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 16 of each part of the study (parts 1-4)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 16 of each part of the study (parts 1-4) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

Secondary study objectives

Part 2 (Period A): Change in Children's Dermatology Life Quality Index (CDLQI)

Part 2 (Period A): Change in Family Dermatology Life Quality Index (FDLQI)

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

+13 more

Side effects data

From 2023 Phase 4 trial • 352 Patients • NCT04908475

14%

COVID-19

NASOPHARYNGITIS

HEADACHE

NAUSEA

UPPER RESPIRATORY TRACT INFECTION

DIARRHOEA

CORONARY ARTERY DISEASE

PROSTATE CANCER

100%

80%

60%

40%

20%

Study treatment Arm

Period B: APR/APR

Period A: APR

Period A: RZB

Period B: RZB/RZB

Period B: APR/RZB

Period B: APR/APR/RZB

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Part 4: Risankizumab Dose A/BExperimental Treatment1 Intervention

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).

Group II: Part 3: Risankizumab Dose A/BExperimental Treatment1 Intervention

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

Group III: Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/BExperimental Treatment2 Interventions

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.

Group IV: Part 2: Risankizumab Dose A/BExperimental Treatment1 Intervention

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).

Group V: Part 1: Risankizumab Dose AExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ustekinumab

2015

Completed Phase 4

~4080

Risankizumab

2021