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JNJ-77242113 for Plaque Psoriasis(SUMMIT Trial)

Phase 2
Waitlist Available
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
Participant has a total Psoriasis Area and Severity Index (PASI) >= 12 at screening and baseline
Participant has a total Investigator's Global Assessment (IGA) >= 3 at screening and baseline
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Upup to week 24
Awards & highlights

SUMMIT Trial Summary

This trial will test if a new oral tablet can effectively treat moderate to severe plaque psoriasis when compared to placebo.

Eligible Conditions
  • Plaque Psoriasis

SUMMIT Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You are not currently receiving light therapy or medicine for plaque psoriasis.
You have been diagnosed with plaque psoriasis (a skin condition) with or without psoriatic arthritis for at least 26 weeks before starting the study.

SUMMIT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 24 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 Severity Index (PASI) 75 Score at Week 16
Secondary outcome measures
Change from Baseline in Body Surface Area (BSA) at Week 16
Change from Baseline in PASI Total Score at Week 16
Number of Participants with Adverse Events (AEs)
+5 more

SUMMIT Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 2: JNJ-77242113 Dose 2Experimental Treatment1 Intervention
Participants will receive JNJ-77242113 Dose 2 as delayed release tablets orally once daily from Week 0 through Week 16.
Group II: Group 1: JNJ-77242113 Dose 1Experimental Treatment1 Intervention
Participants will receive JNJ-77242113 Dose 1 as delayed release tablets orally once daily from Week 0 through Week 16.
Group III: Group 3: PlaceboPlacebo Group1 Intervention
Participants will receive oral dose of matching placebo once daily from Week 0 through Week 16.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 2

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
963 Previous Clinical Trials
6,378,605 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
739 Previous Clinical Trials
3,958,389 Total Patients Enrolled

Frequently Asked Questions

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

Are there any prerequisites for participation in this research project?

"This medical trial is searching for 80 volunteers who are aged between 18 and 75, have had plaque psoriasis (psoriasis vulgaris) for at least 26 weeks prior to receiving the treatment, exhibit a total Body Surface Area of 10% or higher, display an Investigator's Global Assessment greater than 3 points, and present with a Psoriasis Area Severity Index of 12 points or above. Candidates must also be eligible for phototherapy or systemic therapy."

Answered by AI

What kind of geographic scope does the research on this topic encompass?

"ActivMed Practices & Research in Portsmouth, New Hampshire; The Pennsylvania Centre for Dermatology, LLC in Exton, Pennsylvania; and Northshore Universite Healthsystem in Skokie, Illinois are three of the fifteen medical sites participating in this trial. An additional 12 locations are also offering treatment options."

Answered by AI

Is the minimum age requirement for this research investigation over twenty years of age?

"Candidates aged between 18 and 75 are eligible for this trial. Additionally, there are 31 studies open to those under the age of 18, as well as 142 trials available for those over 65 years old."

Answered by AI

Are recruitment efforts underway for this study?

"Affirmative. The clinicaltrials.gov listing confirms that this investigation is actively searching for participants, with the original posting taking place on June 13th 2022 and a recent update occurring on November 22nd 2022. This trial requires 80 people to be recruited from 12 different medical sites."

Answered by AI

Has JNJ-77242113 been certified by the FDA?

"Taking into account the Phase 2 status of JNJ-77242113, our experts have assigned this medication a safety rating of 2. Although some data exists that prove its safety, there is still no evidence to support efficacy."

Answered by AI

Approximately how many individuals have enrolled in this experiment?

"This trial seeks 80 volunteers who are eligible for participation. They can join the clinical study at ActivMed Practices & Research in Portsmouth, New Hampshire or The Pennsylvania Centre for Dermatology, LLC in Exton, Pennsylvania."

Answered by AI
~37 spots leftby Dec 2024