← Back to Search

Monoclonal Antibodies

Ustekinumab for Psoriasis

Phase 4

Recruiting

Led By Kevin Cooper, MD

Research Sponsored by University Hospitals Cleveland Medical Center

Eligibility Criteria Checklist

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

Must have

Insurance that includes an anti-p40 biologic (ustekinumab/Stelara) and at least one anti-p19 biologic (guselkumab/Tremfya or risankizumab/Skyrizi)

Diagnosed with plaque-type psoriasis defined by a board-certified dermatologist, dermatology nurse practitioner, or skin punch biopsy

Must not have

Patients with psoriatic arthritis or other rheumatologic diseases (e.g., Crohn's disease)

Inability to secure ustekinumab and either gusekumab or risankizumab for use while on trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is looking to see if researchers can predict which psoriasis drugs will work for individual patients by looking at markers or gene patterns. Participants will try two different drugs for 8 weeks at a time and have their skin monitored for improvement.

Who is the study for?

This trial is for individuals with plaque-type psoriasis covering at least 10% of their body, who have not used certain biologics or other psoriasis treatments recently. Participants must have insurance that covers the study drugs and be able to give informed consent. Those with psoriatic arthritis, recent use of tanning booths, or women who are pregnant or breastfeeding cannot join.

What is being tested?

The trial aims to personalize psoriasis treatment by predicting responses to FDA-approved drugs Ustekinumab and others using gene patterns. Participants will try two different drugs over periods of 8 weeks while undergoing skin improvement monitoring and providing blood, stool, and skin samples.

What are the potential side effects?

Ustekinumab may cause side effects like infections, allergic reactions, headache, tiredness, joint pain and nausea. The exact side effects from this trial's interventions will depend on individual responses to the medications.

Eligibility Criteria

Inclusion Criteria

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

Select...

My insurance covers Stelara and either Tremfya or Skyrizi.

Select...

I have been diagnosed with plaque-type psoriasis by a skin specialist or through a biopsy.

Select...

I have never been treated with ustekinumab, guselkumab, or risankizumab.

Select...

At least 10% of my skin is affected by my condition.

Exclusion Criteria

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

Select...

I have psoriatic arthritis or another similar condition like Crohn's disease.

Select...

I cannot get ustekinumab, gusekumab, or risankizumab for the trial.

Select...

I have been using skin treatments like steroids or Vitamin D on my lesions for at least 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Identification of a unique differentially expressed gene set in patients with psoriasis that may predict disease response following antagonism to IL-12 and/or IL-23.

Secondary study objectives

Identification of a cell subset that is a modified and predictive of disease response following antagonism to IL-12 and/or IL-23

Side effects data

From 2018 Phase 4 trial • 43 Patients • NCT02187172

50%

Upper respiratory infection

27%

Common cold

Skin and subcutaneous tissue disorders

Fracture

Anxiety

Dizziness

Back pain

Urinary tract infection

Toothache

Rash/Rash Acneiform/Maculo-Papular

Hypertension

Pain/Pain in extremity

100%

80%

60%

40%

20%

Study treatment Arm

Ustekinumab (Stelara)

Placebo (RCT Period)

Placebo (Active Treatment Period)

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

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Patients will be treated with ustekinumab (90mg at week 0 and week 4 by subcutaneous injection) for 8 weeks followed by treatment with guselkumab (100mg at week 0 and week 4 by subcutaneous injection) or risankizumab (150mg at week 0 and week 4 by subcutaneous injection)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ustekinumab

2015

Completed Phase 4

~4080

0 / 7Eligibility criteria met