Guselkumab for Plaque Psoriasis
(SPECTREM Trial)

Recruiting in Palo Alto (17 mi)

+69 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing guselkumab, a medication that targets the immune system, on people with moderate plaque psoriasis affecting small areas and special sites. The drug helps reduce inflammation and rapid skin cell growth. Guselkumab has been approved for the treatment of moderate-to-severe plaque psoriasis.

Eligibility Criteria

This trial is for individuals with a diagnosis of moderate plaque psoriasis covering a low area of the body, who haven't responded well to or can't tolerate at least one topical treatment. They should be eligible for light therapy or systemic treatment and have had psoriasis for over six months. People with non-plaque psoriasis, drug-induced psoriasis, certain palmoplantar conditions, previous biologic treatments, or chronic infections cannot participate.

Inclusion Criteria

I have been diagnosed with plaque psoriasis for at least 6 months.

My condition meets the required severity criteria.

My psoriasis hasn't improved with at least one skin treatment.

+1 more

Exclusion Criteria

My skin condition on my palms and soles has been checked and is not caused by another disease.

I have a history of chronic or recurring infections.

I have never taken biologic drugs for psoriasis, PsA, or related conditions.

+2 more

Participant Groups

The study aims to compare the effectiveness of Guselkumab (a medication) against a placebo (an inactive substance) in treating patients with moderate plaque psoriasis affecting small areas of their body including special sites like palms and soles.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1: GuselkumabExperimental Treatment2 Interventions

Participants will receive guselkumab by subcutaneous injection with placebo as needed to maintain the blind.

Group II: Group 2: PlaceboPlacebo Group2 Interventions

Participants will receive placebo by subcutaneous injection then receive guselkumab by subcutaneous injection.

Guselkumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tremfya for: