NCT05223868|CompletedPhase 2ResultsDMCFDA Drug

A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis

FRONTIER 1

A Phase 2b Multicenter, Randomized, Placebo Controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

Janssen Research & Development, LLC ClinicalTrials.gov

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3 other identifiers

CR1091382021-003700-4177242113PSO2001

Study Type

interventional

Target

255

Locations

10 countries

Sites

Timeline

RegisteredFeb 2022

StartedFeb 2022

CompletionDec 2022

Brief Summary

Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

255

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Feb 2022

Shorter than P25 for phase_2

Geographic Reach

10 countries

76 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

January 24, 2022

Completed

10 days until next milestone

Study Start

First participant enrolled

February 3, 2022

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed

3 years until next milestone

Results Posted

Study results publicly available

December 30, 2025

Completed

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

January 24, 2022

Results QC Date

December 9, 2025

Last Update Submit

February 12, 2026

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 16
Percentage of participants who achieved PASI-75 score (greater than or equal to \[\>=\] 75% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16

Secondary Outcomes (14)

Change From Baseline in PASI Total Score at Week 16
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI (PASI-90) at Week 16
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI (PASI-100) at Week 16
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
At Week 16
Percentage of Participants Who Achieved an IGA Score of Cleared (0) at Week 16
At Week 16
+9 more secondary outcomes

Study Arms (6)

Group 1: JNJ-77242113 Dose 1 Once Daily (QD) and Placebo

EXPERIMENTAL

Participants will receive JNJ-77242113 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.