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Monoclonal Antibodies

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

Phase 3
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Candidate for phototherapy or systemic treatment for plaque psoriasis
Failed to respond to at least 1 topical therapy (example, corticosteroids, calcineurin inhibitors, and/or vitamin D analogs) used for treatment of psoriasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 165 weeks
Awards & highlights

ICONIC-TOTAL Trial Summary

This trial tests if a drug can help people with plaque psoriasis on their scalp, genitals, hands, and feet.

Who is the study for?
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.Check my eligibility
What is being tested?
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).See study design
What are the potential side effects?
Possible side effects of JNJ-77242113 may include reactions related to allergies or hypersensitivity since participants with known intolerance to its components are excluded from the trial.

ICONIC-TOTAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am eligible for light therapy or medication for my plaque psoriasis.
Select...
I have tried at least one skin cream for psoriasis without success.
Select...
I have plaque psoriasis on parts of my body other than my scalp, genitals, or palms/soles.

ICONIC-TOTAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 165 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 165 weeks 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 an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2 Grade Improvement From Baseline at Week 16
Secondary outcome measures
Change From Baseline in BSA at Week 16
Change From Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-25 (PROMIS-25) Score at Week 16
Change From Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16
+26 more

ICONIC-TOTAL Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: JNJ-77242113Experimental Treatment1 Intervention
Participants will receive JNJ-77242113 from Week 0 through Week 156.
Group II: PlaceboPlacebo Group2 Interventions
Participants will receive placebo from Week 0 through Week 16 and thereafter will receive JNJ-77242113 from Week 16 through Week 156.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-77242113
2022
Completed Phase 2
~640

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,073 Total Patients Enrolled
Janssen Research &Development, LLC Clinical trialStudy DirectorJanssen Research & Development, LLC

Frequently Asked Questions

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

What potential perils does JNJ-77242113 present to individuals undergoing treatment?

"There is a considerable amount of data attesting to the safety of JNJ-77242113, thus it was given an overall rating of 3. This conclusion is based on its Phase 3 status and numerous clinical studies bolstering its efficacy."

Answered by AI

To what extent are medical facilities running this experiment?

"Patients may enrol in this study at the Indiana Clinical Trial Center in Plainfield, Dermatology and Advanced Aesthetics located in Lake Charles, Louisiana, or Minnesota Clinical Study Centre based in New Brighton. Additionally there are four other sites accepting participants."

Answered by AI

Is it currently feasible to partake in this research trial?

"Affirmative. The information found on clinicaltrials.gov asserts that this current trial, first published on October 12th 2023, is actively recruiting participants for the study. 300 individuals need to be recruited from 7 distinct medical centres."

Answered by AI

How many participants are involved in this experiment?

"Affirmative. Clinicaltrials.gov documents that this trial, initially posted on October 12th 2023, is actively searching for participants. 300 people must be recruited from seven distinct sites."

Answered by AI

Who else is applying?

What site did they apply to?
Center for Dermatology and Plastic Surgery
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet)
2023. "A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06095102.
All > Psoriasis > Plaque Psoriasis
~150 spots leftby Nov 2024
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