Guselkumab for Plaque Psoriasis

(SPECTREM Trial)

Recruiting at 69 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must not be taking: Biologics, TNF-inhibitors, IL-inhibitors

Disqualifiers: Nonplaque psoriasis, Drug-induced psoriasis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

338 Participants Needed

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.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive guselkumab or placebo by subcutaneous injection

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

40 weeks

Treatment Details

Interventions

• Guselkumab
• Placebo

Trial Overview 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.

Participant Groups

Group I: Group 1: Guselkumab Experimental Treatment 2 Interventions

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

Group II: Group 2: Placebo Placebo Group 2 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:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Moderately to severely active ulcerative colitis

Approved in European Union as Tremfya for:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Moderately to severely active ulcerative colitis

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires