JNJ-77242113 for Plaque Psoriasis

(ICONIC-TOTAL Trial)

Recruiting at 108 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must not be taking: Beta blockers, Calcium channel blockers, Lithium

Disqualifiers: Nonplaque psoriasis, Severe organ disturbances, 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: 156 weeks

311 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called JNJ-77242113 to see if it can help people with plaque psoriasis in hard-to-treat areas like the scalp, genital area, and palms/soles. The medication works by calming the immune system and slowing down skin cell growth. The goal is to find a more effective treatment for these challenging cases.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if your psoriasis is drug-induced, you may not be eligible to participate.

What safety data exists for JNJ-77242113 in treating plaque psoriasis?

The safety of JAK inhibitors, a group of drugs that includes JNJ-77242113, has been studied in plaque psoriasis. These drugs generally have a safety profile similar to placebo, except for some doses of deucravacitinib. Tofacitinib, another JAK inhibitor, showed a relatively low incidence of side effects. ^{1 2 3 4 5}

Research Team

Janssen Research &Development, LLC Clinical trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for people who've had plaque psoriasis, including on the scalp, genitals, or palms and soles of the feet, for at least half a year. They should need systemic treatment or phototherapy and have tried at least one topical therapy without success. Participants must not have non-plaque psoriasis types or skin conditions that could interfere with the study.

Inclusion Criteria

I have plaque psoriasis on parts of my body other than my scalp, genitals, or palms/soles.

I am eligible for light therapy or medication for my plaque psoriasis.

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

Exclusion Criteria

My psoriasis started or got worse after taking certain medications.

I do not have severe or worsening problems with my kidneys, liver, heart, blood vessels, lungs, stomach, hormones, nerves, blood, joints, mind, or metabolism.

My psoriasis is not the plaque type but another form like guttate or pustular.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JNJ-77242113 or placebo for 16 weeks, followed by JNJ-77242113 for up to 156 weeks

156 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• JNJ-77242113

Trial Overview The trial tests JNJ-77242113's effectiveness against placebo in treating plaque psoriasis in sensitive areas. It aims to see if this new medication can improve symptoms better than a non-active treatment (placebo).

Participant Groups

Group I: JNJ-77242113 Experimental Treatment 1 Intervention

Participants will receive JNJ-77242113 from Week 0 through Week 156.

Group II: Placebo Placebo Group 2 Interventions

Participants will receive placebo from Week 0 through Week 16 and thereafter will receive JNJ-77242113 from Week 16 through Week 156.

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

Findings from Research

In a real-world study of 1756 patients with moderate-to-severe plaque-type psoriasis, secukinumab demonstrated high treatment retention rates of 88.0% after 1 year, 76.4% after 2 years, and 60.5% after 3 years, indicating its effectiveness in long-term management.

The safety profile of secukinumab remained consistent with previous findings, showing low rates of serious adverse events such as inflammatory bowel disease (0.3%) and candida infections (3.1%), suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab demonstrated sustained retention, effectiveness and safety in a real-world setting in patients with moderate-to-severe plaque psoriasis: long-term results from an interim analysis of the SERENA study. Augustin, M., Sator, PG., von Kiedrowski, R., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Janus kinase inhibitors in patients with psoriasis and psoriatic arthritis: a systematic review and meta-analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The efficacy and safety of tofacitinib, peficitinib, solcitinib, baricitinib, abrocitinib and deucravacitinib in plaque psoriasis - A network meta-analysis. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Relative efficacy and safety of Janus kinase inhibitors for the treatment of active psoriatic arthritis: a network meta-analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Secukinumab demonstrated sustained retention, effectiveness and safety in a real-world setting in patients with moderate-to-severe plaque psoriasis: long-term results from an interim analysis of the SERENA study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. [2021]