Guselkumab for Plaque Psoriasis

(SPECTREM Trial)

No longer recruiting at 71 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called guselkumab to evaluate its effectiveness for people with moderate plaque psoriasis, particularly in areas like the scalp, face, and genitals. Participants will receive either guselkumab (an injection) or a placebo (an inactive substance) as an injection. The trial seeks individuals who have had plaque psoriasis for at least six months and have tried at least one topical treatment without success. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to the potential availability of a new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, it does mention that participants should not have used certain biologic drugs before. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that guselkumab is safe for treating plaque psoriasis. Studies have found that people using guselkumab for up to five years experienced positive results and tolerated it well. Unwanted side effects were similar to those expected with other psoriasis treatments. Most side effects were mild, such as colds or headaches. Overall, clinical trials support guselkumab's safety for people with moderate-to-severe plaque psoriasis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for plaque psoriasis?

Guselkumab is unique because it specifically targets interleukin-23 (IL-23), a protein that plays a key role in the inflammation process of plaque psoriasis. Unlike many standard treatments, such as methotrexate or cyclosporine, which broadly suppress the immune system, guselkumab offers a more targeted approach, potentially reducing side effects. Researchers are excited about guselkumab because its targeted action not only promises effectiveness in reducing psoriasis symptoms but also enhances safety by minimizing the impact on the rest of the immune system.

What evidence suggests that guselkumab might be an effective treatment for plaque psoriasis?

Research has shown that guselkumab, which participants in this trial may receive, effectively treats plaque psoriasis. In clinical studies, patients experienced significant improvements in symptoms like itching, burning, and skin pain by week 16. About 64% of patients achieved nearly clear skin at this time. Another study found that guselkumab helped most adults with moderate plaque psoriasis, even when it affected a small area of their body, to achieve clear or almost clear skin. This treatment demonstrated meaningful improvements in disease activity and patient-reported outcomes over 9–12 months. Overall, guselkumab consistently delivers strong results in clearing skin and reducing psoriasis symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. tremfya.com tremfya.com/plaque-psoriasis/results/

study results In clinical studies, at 16 weeks, patients had improvements in symptoms of plaque psoriasis including itching, burning, pain, stinging, and skin tightness.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9884726/

Effectiveness of Guselkumab Therapy among Patients with ... The results show that 9–12 months of guselkumab treatment is associated with meaningful improvements in numerous assessments of disease activity and PROMs in a ...

3. tremfyahcp.com tremfyahcp.com/plaque-psoriasis/skin-clearance-data/

Skin Clearance Data: Moderate to Severe Plaque PsO Clearer skin is possible · 64% (102/160) of patients receiving TREMFYA® achieved PASI 90 response at Week 16 · 71% (113/160) of patients receiving TREMFYA® ...

4. jnj.com jnj.com/media-center/press-releases/new-spectrem-study-findings-reveal-tremfya-guselkumab-effectively-clears-overlooked-and-undertreated-plaque-psoriasis

New SPECTREM study findings reveal TREMFYA® ... Treatment with TREMFYA (guselkumab) resulted in clear or almost clear skin in the majority of adults with low body surface area (BSA) moderate plaque psoriasis ...

5. jnjmedicalconnect.com jnjmedicalconnect.com/products/tremfya/medical-content/tremfya-efficacy-outcomes-by-weight-in-adult-patients-with-plaque-psoriasis-or-psoriatic-arthritis

TREMFYA - Efficacy Outcomes by Weight in Adult Patients ... Efficacy of guselkumab versus secukinumab in subpopulations of patients with moderate-to-severe plaque psoriasis: results from the ECLIPSE study ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37022762/

Safety of guselkumab treatment for up to 5 years in patients ... Guselkumab has demonstrated favourable safety and efficacy across individual clinical studies in adults with moderate-to-severe plaque psoriasis.

7. academic.oup.com academic.oup.com/bjd/advance-article/doi/10.1093/bjd/ljaf327/8242849

guselkumab efficacy and safety for the treatment of low body ... Our results show that clear or almost clear skin in all body regions was achieved in most people with psoriasis after three doses of guselkumab.

8. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2835459

Guselkumab for Moderate to Severe Psoriasis Across All ... This randomized clinical trial evaluates the efficacy, quality of life, and adverse event outcomes of guselkumab, 100 mg, among patients ...