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Monoclonal Antibodies

Guselkumab for Psoriatic Arthritis (APEX Trial)

Phase 3

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

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

Must have

Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis

Have active PsA as defined by: at least 3 swollen joints and 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory

Must not have

Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention

Has previously received any biologic treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 168 weeks

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new drug for people with psoriatic arthritis to see if it can reduce symptoms.

Who is the study for?

This trial is for people with active psoriatic arthritis who've tried other treatments like DMARDs, apremilast, or NSAIDs without enough relief. They should have symptoms like swollen and tender joints, a certain level of inflammation in their blood, and joint damage visible on X-rays. It's not for those with other inflammatory diseases that could affect results or anyone allergic to the study drug.

What is being tested?

The trial tests Guselkumab's effectiveness against PsA by comparing it to a placebo. Participants will be randomly assigned to receive either Guselkumab or an inactive substance (placebo) to see if there's a significant improvement in their PsA symptoms.

What are the potential side effects?

Guselkumab may cause side effects such as infections, headaches, injection site reactions (like pain or swelling), and possibly allergic reactions. The exact side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I have active psoriasis with a plaque larger than 2cm or nail changes.

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I have Psoriatic Arthritis with at least 3 swollen and 3 tender joints, and my CRP levels are high.

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I have been diagnosed with Psoriatic Arthritis for at least 6 months.

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I have active psoriatic arthritis and treatments like DMARDs or NSAIDs haven't worked.

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I have a type of psoriatic arthritis affecting my joints or spine.

Exclusion Criteria

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

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I haven't taken any immune system suppressing drugs in the last 4 weeks.

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I have received biological therapy before.

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I have taken a JAK inhibitor medication before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 168 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 168 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 168 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

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24

Secondary study objectives

Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24

Number of Participants With Change from Baseline in Clinical Laboratory Abnormalities

Number of Participants with AEs Temporally Associated With an Injection-site Reactions

+6 more

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323

Nasopharyngitis

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Ixekizumab Post-Treatment Follow Up

Ixekizumab

Guselkumab

Guselkumab Post-Treatment Follow Up

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 3: Placebo Followed by GuselkumabExperimental Treatment2 Interventions

Participants will receive placebo SC and will cross over to receive SC guselkumab. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.

Group II: Group 2: GuselkumabExperimental Treatment1 Intervention

Participants will receive guselkumab SC. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.

Group III: Group 1: Guselkumab and PlaceboExperimental Treatment2 Interventions

Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind. Participants who have not discontinued will be eligible to enter a long-term extension (LTE) and will receive guselkumab and placebo SC. After the study is unblinded to the investigative sites, participants will receive guselkumab and no longer be required to dose with placebo to maintain the blind.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Guselkumab

2015

Completed Phase 4

~6080

Placebo

1995

Completed Phase 3

~2670