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Monoclonal Antibodies

JNJ-77242113 for Plaque Psoriasis(ICONIC-LEAD Trial)

Optima Research, Boardman, OH

JNJ-77242113 +1 morePhase 3RecruitingResearch Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

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

Must have

Total psoriasis area and severity index (PASI) >=12 at screening and baseline

Candidate for phototherapy or systemic treatment for plaque psoriasis

Must not have

Timeline

Screening 3 weeks

Treatment Varies

Follow Upweek 24 to week 52

Awards & highlights

Pivotal Trial

ICONIC-LEAD Trial Summary

This trial will study if a new drug is effective at treating moderate to severe plaque psoriasis.

Eligible Conditions

Plaque Psoriasis

ICONIC-LEAD Trial Eligibility Criteria

Inclusion Criteria

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

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You have a PASI score of at least 12, indicating severe psoriasis.

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You are eligible for either light-based or systemic medication treatments for plaque psoriasis.

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Female participants of childbearing potential must have a negative serum pregnancy test beta-human chorionic gonadotropin (beta-hCG) and a negative urine pregnancy test prior to receiving the study intervention.

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At the initial screening and start of the study, you have a minimum overall investigator assessment score of 3 or higher.

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You have had a diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 consecutive weeks prior to receiving the study intervention.

ICONIC-LEAD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24 to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24 to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16

Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>= )2-Grade Improvement From Baseline to Week 16

Secondary outcome measures

Change From Baseline in CDLQI at Week 16

Change From Baseline in PSSD Sign Score to Week 16

Change From Baseline in PSSD Symptom Score to Week 16

+31 more

Awards & Highlights

Pivotal Trial

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

ICONIC-LEAD Trial Design

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment2 Interventions

Adolescent and adult participants will receive JNJ-77242113 matching placebo from Week 0 to Week 16. Participants will cross-over to receive JNJ-77242113 from Week 16 through Week 156.

Group II: JNJ-77242113Experimental Treatment1 Intervention

Adolescent and adult participants will receive JNJ-77242113 from Week 0 through Week 156. At Week 24, adult participants who are psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieve an IGA score of 0 or 1 and have >=2-grade improvement from baseline) will be re-randomized either to continue JNJ-77242113 or to placebo (and will be retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Adult participants identified as both PASI 75 and IGA 0 or 1 score non-responders will continue to receive JNJ-77242113 through Week 52. From Week 52 to Week 156, all adult participants will receive JNJ-77242113. Adolescents will not participate in re-randomization regardless of their PASI score or IGA score at Week 24. Adolescents will continue to receive JNJ-77242113 from Week 0 through Week 156.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

JNJ-77242113

2022

Completed Phase 2

~640

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

965 Previous Clinical Trials

6,380,715 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

740 Previous Clinical Trials

3,957,979 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrolment capacity for this investigation?

"This study requires 600 participants who meet its prerequisites to take part. Individuals can enrol through the Indiana Clinical Trial Center in Plainfield, IN or Dermatology and Advanced Aesthetics in Lake Charles, LA."

Answered by AI

Are there copious facilities executing this research in North America?

"Indiana Clinical Trial Center in Plainfield, Dermatology and Advanced Aesthetics in Lake Charles, Michigan Center of Medical Research in Clarkston, and 6 other sites are providing this medical treatment."

Answered by AI

Are individuals eligible to participate in this experimental research at the present time?

"According to clinicaltrials.gov, the search for participants is ongoing and has been since October 12th 2023 when it was posted; as of 18th October that date had not changed."

Answered by AI

Has JNJ-77242113 been granted sanction by the FDA?

"Judging by the Phase 3 trial data, our experts at Power rate JNJ-77242113 as a 3 on the safety scale. This is because there exists supportive evidence of its efficacy and validated research that corroborates its security."

Answered by AI

What is the intended outcome of this experiment?

"The purpose of the study, which will be observed from Baseline to Week 16 is to analyse how many participants achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16. Secondary assessments include tracking PASI 75 Responses (>=75% improvement in PASI from baseline) at Weeks 4 and 16, as well as evaluating patients' reactions to reaching a PASI 90 Response (>=90% improvement in PASI from baseline) at Week 8 or achieving a full-fledged remission with a score of 100 by Week 16. The comprehensive evaluation system for this trial - known as the"

Answered by AI

Who else is applying?

What site did they apply to?

Center for Dermatology Clinical Research

What portion of applicants met pre-screening criteria?

Met criteria

Why did patients apply to this trial?

I had attend 100% clear skin after being on Solara for many years. I had an operation this year and my psoriasis has gone crazy. I need to do this get fixed again.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis

2023. "A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06095115.

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