A Study to Investigate the Safety and Efficacy of Multiple Doses of JNJ-77242113 in Participants with Moderate to Severe Plaque Psoriasis

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 - FRONTIER 1: Efficacy and Safety of JNJ-77242113 in Moderate to Severe Plaque Psoriasis

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003700-41-ES

Enrollment

240

Registered

2021-12-17

Start date

2022-03-09

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858

Interventions

Product Name: JNJ-77242113 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Not available CAS Number: Not assigned Current Sponsor code: JNJ-77242113 Other descriptive name: PN-235, JNJ-77

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female =18 years of age 2. Has a diagnosis of plaque psoriasis, with or without PsA, for at least 6 months prior to the first administration of study intervention 3. Has a total BSA =10% at screening and baseline. 4. Has a total PASI =12 at screening and baseline. 5. Has a total IGA =3 at screening and baseline. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 216 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24

Exclusion criteria

Exclusion criteria: 1. Has a nonplaque form of psoriasis 2. Has current drug-induced psoriasis 3. Has previously received any other therapeutic agent directly targeted to IL-23 4. Has received any therapeutic agent directly targeted to IL-17 or IL-12/23 or has received anti-TNFa biologic therapy within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention 5. Has received agents that modulate B cells within 26 weeks of the first administration of study intervention

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the dose response of JNJ-77242113 at Week 16 in participants with moderate-to-severe plaque psoriasis;Secondary Objective: - To characterize additional efficacy of JNJ-77242113 versus placebo in participants with moderate-to-severe plaque psoriasis - To evaluate the effect of JNJ-77242113 treatment on patient-reported psoriasis severity versus placebo in participants with moderate-to-severe plaque psoriasis - To evaluate the effect of JNJ-77242113 treatment on dermatology-specific health-related quality of life versus placebo in participants with moderate-to-severe plaque psoriasis - To evaluate the effect of JNJ-77242113 treatment on general health-related quality of life versus placebo in participants with moderate-to-severe plaque psoriasis - To assess the safety and tolerability of JNJ-77242113 in participants with moderate-to-severe plaque psoriasis;Primary end point(s): Proportion of participants achieving PASI 75 (=75% improvement from baseline in PASI);Timepoint(s) of evaluation of this end point: Week 16	—

Measure

Time frame

Main Objective: To evaluate the dose response of JNJ-77242113 at Week 16 in participants with moderate-to-severe plaque psoriasis;Secondary Objective: - To characterize additional efficacy of JNJ-77242113 versus placebo in participants with moderate-to-severe plaque psoriasis - To evaluate the effect of JNJ-77242113 treatment on patient-reported psoriasis severity versus placebo in participants with moderate-to-severe plaque psoriasis - To evaluate the effect of JNJ-77242113 treatment on dermatology-specific health-related quality of life versus placebo in participants with moderate-to-severe plaque psoriasis - To evaluate the effect of JNJ-77242113 treatment on general health-related quality of life versus placebo in participants with moderate-to-severe plaque psoriasis - To assess the safety and tolerability of JNJ-77242113 in participants with moderate-to-severe plaque psoriasis;Primary end point(s): Proportion of participants achieving PASI 75 (=75% improvement from baseline in PASI);Timepoint(s) of evaluation of this end point: Week 16

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Secondary

Measure	Time frame
Secondary end point(s): - Change from baseline in PASI total score - Proportion of participants achieving PASI 90 (=90% improvement from baseline in PASI) - Proportion of participants achieving PASI 100 (100% improvement from baseline in PASI) - Proportion of participants achieving an IGA score of cleared (0) or minimal (1) - Proportion of participants achieving an IGA score of cleared (0) - Change from baseline in BSA - Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) symptoms scores - Change from baseline in PSSD signs score - Proportion of participants achieving PSSD symptoms score=0 among participants with a baseline symptoms score =1 - Proportion of participants achieving PSSD signs score=0 among participants with a baseline signs score =1 - Proportion of participants achieving a DLQI of 0 or 1 among participants with baseline DLQI score >1 - Change from baseline in domain scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Proportion of participants who achieve at least a 5-point improvement from baseline in each PROMIS-29 domain - Frequency and type of AEs and SAEs;Timepoint(s) of evaluation of this end point: Week 16	—

Measure

Time frame

Secondary end point(s): - Change from baseline in PASI total score - Proportion of participants achieving PASI 90 (=90% improvement from baseline in PASI) - Proportion of participants achieving PASI 100 (100% improvement from baseline in PASI) - Proportion of participants achieving an IGA score of cleared (0) or minimal (1) - Proportion of participants achieving an IGA score of cleared (0) - Change from baseline in BSA - Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) symptoms scores - Change from baseline in PSSD signs score - Proportion of participants achieving PSSD symptoms score=0 among participants with a baseline symptoms score =1 - Proportion of participants achieving PSSD signs score=0 among participants with a baseline signs score =1 - Proportion of participants achieving a DLQI of 0 or 1 among participants with baseline DLQI score >1 - Change from baseline in domain scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Proportion of participants who achieve at least a 5-point improvement from baseline in each PROMIS-29 domain - Frequency and type of AEs and SAEs;Timepoint(s) of evaluation of this end point: Week 16

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Countries

Canada, Czechia, France, Germany, Japan, Korea, Republic of, Poland, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactGlobal Clinical Operations

Janssen-Cilag, S.A

ccarrill@its.jnj.com+34650 93 95 53

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026