← Back to Search

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
Diagnosis of chronic plaque psoriasis for at least 6 months before the Baseline Visit
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 16 of each part of the study (parts 1-4)
Awards & highlights

OptIMMize-1 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.Check my eligibility
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.See study design
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.

OptIMMize-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with chronic plaque psoriasis for at least 6 months.
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.
Select...
I am eligible for drug treatment as confirmed by my doctor.

OptIMMize-1 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 2022 Phase 3 trial • 244 Patients • NCT04102007
9%
COVID-19
6%
NASOPHARYNGITIS
1%
OSTEOARTHRITIS
1%
MYOCARDIAL INFARCTION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risankizumab

OptIMMize-1 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
2013
Completed Phase 4
~4140
Risankizumab
2021
Completed Phase 3
~3140

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
945 Previous Clinical Trials
496,271 Total Patients Enrolled
61 Trials studying Psoriasis
125,144 Patients Enrolled for Psoriasis
ABBVIE INC.Study DirectorAbbVie
387 Previous Clinical Trials
141,024 Total Patients Enrolled
21 Trials studying Psoriasis
17,595 Patients Enrolled for Psoriasis

Media Library

Risankizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04435600 — Phase 3
Psoriasis Research Study Groups: Part 4: Risankizumab Dose A/B, Part 2: Risankizumab Dose A/B, Part 1: Risankizumab Dose A, Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B, Part 3: Risankizumab Dose A/B
Psoriasis Clinical Trial 2023: Risankizumab Highlights & Side Effects. Trial Name: NCT04435600 — Phase 3
Risankizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04435600 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What therapeutic benefits has Risankizumab been shown to provide patients?

"Risankizumab is often used as a systemic therapy for patients with certain conditions. In addition, it can help those struggling with infection, invasive procedures, and dental plaque."

Answered by AI

Are there any other similar medical experiments that have used Risankizumab?

"As of now, 63 studies involving Risankizumab are ongoing with 32 of them in Phase 3. Out of the 5688 total locations conducting these investigations, several are based in Nice, Bretagne."

Answered by AI

What are researchers expecting to find at the end of this clinical trial?

"According to the trial sponsor, AbbVie, the primary outcome of this study will be the percentage of participants that achieve a static Physician's Global Assessment (sPGA) of clear or almost clear. This will be measured over a 16 week period across all 4 parts of the trial. Additionally, the study will also assess secondary outcomes including change in Family Dermatology Life Quality Index (FDLQI) and percentage of participants achieving PASI 100 or PASI 75."

Answered by AI

How many patients are participating in this research project?

"That is correct, the online information from clinicaltrials.gov verifies that this study is still looking for patients to enroll. The clinical trial was initially posted on 7/14/2020, with the most recent edit on 10/12/2022. They are looking for 132 individuals total, across 23 different sites."

Answered by AI

Are there any restrictions for who can participate in this research project?

"This study is looking for 132 pediatric patients, aged 6 to 17, who have been diagnosed with psoriasis. In addition to this age and diagnosis criteria, patients must also have stable plaque psoriasis, as defined by the Psoriasis Area and Severity Index (PASI) and Static Physician Global Assessment (sPGA). They must also be candidates for systemic therapy, as assessed by the investigator, and meet the disease activity criteria at both the Screening and Baseline Visits per the protocol."

Answered by AI

Will this experiment be available to patients who are over 40 years old?

"The minimum age for participation in this trial is 6 years old and the age limit is 17 years old."

Answered by AI

Can people with the qualifying health condition participate in this research?

"This study, as indicated on clinicaltrials.gov, is open for recruitment. The trial was initially posted on July 14th, 2020 and was last updated on October 12th, 2020."

Answered by AI

Has Risankizumab gone through all the necessary channels for government approval?

"Risankizumab has efficacy data from a Phase 3 trial and multiple rounds of safety data, so it received a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
What portion of applicants met pre-screening criteria?
Did not meet criteria
~28 spots leftby Mar 2025