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Risankizumab vs Deucravacitinib for Psoriasis (IMMpactful Trial)

Verified Trial

Phase 4

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Stable moderate chronic plaque psoriasis at both Screening and Baseline as defined as: Body Surface Area (BSA) ≥ 10% and ≤ 15%, Psoriasis Area and Severity Index (PASI) ≥ 12, and Static Physician Global Assessment (sPGA) = 3 (moderate) based on a 5-point scale (0 to 4)

Be older than 18 years old

Must not have

Participants with evidence of: Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, Human immunodeficiency virus (HIV) with unstable disease, Recent (within past 6 months) cerebrovascular accident or myocardial infarction, History of an organ transplant requiring continued immunosuppression, Active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix, Prior history of suicide attempt, major depression, or suicidal ideation or attempt requiring hospitalization within the last 3 years

Hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 52

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to enroll 336 adults with moderate chronic plaque psoriasis to study two different treatments. The participants will receive either a subcutaneous injection of risankizumab every 12 weeks

Who is the study for?

This trial is for adults over 18 with moderate chronic plaque psoriasis for at least 6 months, who haven't tried biologic treatments. They should have a Psoriasis Area and Severity Index (PASI) score of ≥12, Body Surface Area (BSA) affected by psoriasis between 10% to 15%, and a moderate rating on the Static Physician Global Assessment (sPGA). It's not suitable for those well-managed by topicals or other therapies.

What is being tested?

The study compares Risankizumab, given as an injection every 12 weeks, against Deucravacitinib taken orally daily in patients with plaque psoriasis. This Phase 4 trial is open-label and assesses the safety and effectiveness of these approved treatments through regular medical assessments.

What are the potential side effects?

Potential side effects are not listed in the provided information but may include typical reactions associated with immunomodulatory drugs such as infections, injection site reactions for Risankizumab, or gastrointestinal issues for oral medications like Deucravacitinib.

Eligibility Criteria

Inclusion Criteria

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

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My psoriasis covers 10-15% of my body and is moderately severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a genetic condition that affects how my body processes certain sugars.

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I do not have skin conditions that could affect psoriasis assessment.

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I have severe kidney problems or am on dialysis.

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I haven't had major surgery in the last 12 weeks nor plan to during the study.

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I haven't taken strong medication that affects liver enzymes in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 52 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Period A: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90)

Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Almost Clear) with at least 2-grade improvement from Baseline

Period B: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) in the Intent to Treat Population for non-responders in Period B (ITT_B_NR).

Secondary study objectives

Period A: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100)

Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 with at least 2-grade improvement from Baseline

Period B: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) among participants in the ITT_B_NR Population

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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: Period B: Arm 2b Deucravacitinib Dose AExperimental Treatment1 Intervention

Participants initially randomized to Deucravacitinib (Arm 2) will be re-randomized at the Week 16 visit to receive Deucravacitinib orally once per day up to Week 52

Group II: Period B: Arm 2a Risankizumab Dose A (Continued)Experimental Treatment1 Intervention

Participants initially randomized to risankizumab (Arm 1) will continue to receive risankizumab as a single SC injection at Weeks 16, 28, and 40

Group III: Period B: Arm 2a Risankizumab Dose AExperimental Treatment1 Intervention

Participants initially randomized to Deucravacitinib (Arm 2) will be re-randomized at the Week 16 visit to receive Risankizumab as a single SC injection at Weeks 16, 20, 32, and 44

Group IV: Period A: Arm 2 Deucravacitinib Dose AExperimental Treatment1 Intervention

Participants will be centrally randomized at the Baseline (Day 1) visit to receive Deucravacitinib orally once per day until the day prior to Week 16

Group V: Period A: Arm 1 Risankizumab Dose AExperimental Treatment1 Intervention

Participants will be centrally randomized at the Baseline (Day 1) visit to receive Risankizumab as a single SC injection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Risankizumab

2021

Completed Phase 4

~3340