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Risankizumab for Psoriasis

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

Study Summary

This trial will assess the safety and efficacy of risankizumab compared to apremilast in adult participants with moderate plaque psoriasis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 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 PASI 90 in Intent to Treat Population for Period B Non-Responders (ITT_B_NR)
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population in Period A (ITT_A)
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at least 2-grade Improvement From Baseline in Intent to Treat Population in Period A (ITT_A)
Secondary outcome measures
Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population in Period A (ITT_A)
Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Period B Non-Responders (ITT_B_NR)
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at least 2-grade Improvement From Baseline in Intent to Treat Population for Period B Non-Responders (ITT_B_NR)

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

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2a: Apremilast/RisankizumabExperimental Treatment2 Interventions
Participants will receive apremilast Dose A in Period A followed by risankizumab Dose A in Period B.
Group II: Arm 1: RisankizumabExperimental Treatment1 Intervention
Participants will receive risankizumab Dose A in Period A and Period B.
Group III: Arm 2b: ApremilastActive Control2 Interventions
Participants will receive apremilast Dose A in Period A and Period B. Non-responders at Week 28 and Week 40 will be offered to receive risankizumab Dose A.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Risankizumab
2021
Completed Phase 3
~3140
Apremilast
2017
Completed Phase 4
~2500

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
952 Previous Clinical Trials
500,132 Total Patients Enrolled
62 Trials studying Psoriasis
125,260 Patients Enrolled for Psoriasis
ABBVIE INC.Study DirectorAbbVie
392 Previous Clinical Trials
144,966 Total Patients Enrolled
22 Trials studying Psoriasis
17,711 Patients Enrolled for Psoriasis

Frequently Asked Questions

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

What other research has been conducted on Risankizumab?

"Memorial Sloan Kettering Cancer Center first researched risankizumab in 2011 and, since then, there have been a total of 179 completed studies. As of now, there are 42 ongoing trials; many of these taking place in Montréal, Quebec."

Answered by AI

What are the top indications for Risankizumab?

"Risankizumab is an effective medical intervention for treating infections, invasive procedures, and dental plaque."

Answered by AI

Are new participants still being enrolled in this clinical trial?

"According to the latest information available on clinicaltrials.gov, this trial is not currently looking for volunteers. The study was first posted on June 9th, 2021 and was last updated January 25th, 2022. Although this specific trial isn't searching for participants at the moment, there are 221 other trials that are actively recruiting patients right now."

Answered by AI

How many patients are being given the chance to participate in this clinical trial?

"This particular clinical trial is not seeking new patients at the moment. The study was originally posted on June 9th, 2021 and has had one edit since then on January 25th, 2022. Alternative studies that may be of interest include 179 trials for psoriasis and 42 for Risankizumab which are both actively recruiting participants right now."

Answered by AI

Is Risankizumab known to cause any adverse health effects?

"There is both efficacy and safety data available for Risankizumab because it has progressed to Phase 3 clinical trials. Our team rates the safety of this medication as a 3."

Answered by AI

Could you please share how many different hospitals are conducting this research?

"To make things more convenient for enrollees, the 36 sites running this trial are located in or near major cities like Montréal, Rockville and Clarkston. There are also another 33 locations spread out across these cities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy
2021. "Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04908475.
~92 spots leftby Apr 2025
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