NCT05223868: FRONTIER 1

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

Completed Phase 2 Results posted Last updated 13 February 2026

What this trial tests

Phase 2 trial testing JNJ-77242113 in Plaque Psoriasis in 255 participants. Completed in 15 December 2022.

Timeline

3 February 2022

Primary endpoint
15 December 2022

15 December 2022

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	255
Start date	3 February 2022
Primary completion	15 December 2022
Estimated completion	15 December 2022
Sites	76 locations across France, Japan, Taiwan, United Kingdom, Germany, Poland, South Korea, Canada

Drugs / interventions tested

• JNJ-77242113 — full drug profile →
• Placebo

Conditions studied

• Plaque Psoriasis — all drugs for Plaque Psoriasis →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

18 and older, any sex, with Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 16 Primary · Baseline (Week 0), 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 exten

Group	Value	95% CI
Placebo	9.3
JNJ-77242113 25 mg QD	37.2
JNJ-77242113 50 mg QD	58.1
JNJ-77242113 25 mg BID	51.2
JNJ-77242113 100 mg QD	65.1
JNJ-77242113 100 mg BID	78.6

Change From Baseline in PASI Total Score at Week 16 Secondary · Baseline (Week 0), Week 16

Change from baseline in PASI total score 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

Group	Value	95% CI
Placebo	-3.59	± 9.436
JNJ-77242113 25 mg QD	-12.76	± 8.050
JNJ-77242113 50 mg QD	-14.56	± 6.528
JNJ-77242113 25 mg BID	-12.73	± 8.021
JNJ-77242113 100 mg QD	-13.99	± 8.653
JNJ-77242113 100 mg BID	-17.44	± 8.356

Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI (PASI-90) at Week 16 Secondary · Baseline (Week 0), Week 16

Percentage of participants who achieved PASI-90 score (\>=90% 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 (ind

Group	Value	95% CI
Placebo	2.3
JNJ-77242113 25 mg QD	25.6
JNJ-77242113 50 mg QD	51.2
JNJ-77242113 25 mg BID	26.8
JNJ-77242113 100 mg QD	46.5
JNJ-77242113 100 mg BID	59.5

Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI (PASI-100) at Week 16 Secondary · Baseline (Week 0), Week 16

Percentage of participants who achieved PASI-100 score (100% 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 was 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 (indicat

Group	Value	95% CI
Placebo	0
JNJ-77242113 25 mg QD	11.6
JNJ-77242113 50 mg QD	25.6
JNJ-77242113 25 mg BID	9.8
JNJ-77242113 100 mg QD	23.3
JNJ-77242113 100 mg BID	40.5

Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 Secondary · At Week 16

The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (\>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occa

Group	Value	95% CI
Placebo	11.6
JNJ-77242113 25 mg QD	39.5
JNJ-77242113 50 mg QD	58.1
JNJ-77242113 25 mg BID	51.2
JNJ-77242113 100 mg QD	62.8
JNJ-77242113 100 mg BID	64.3

Percentage of Participants Who Achieved an IGA Score of Cleared (0) at Week 16 Secondary · At Week 16

The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less th

Group	Value	95% CI
Placebo	0
JNJ-77242113 25 mg QD	16.3
JNJ-77242113 50 mg QD	34.9
JNJ-77242113 25 mg BID	14.6
JNJ-77242113 100 mg QD	27.9
JNJ-77242113 100 mg BID	45.2

Change From Baseline in Body Surface Area (BSA) at Week 16 Secondary · Baseline (Week 0) and Week 16

A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.

Group	Value	95% CI
Placebo	-2.4	± 16.51
JNJ-77242113 25 mg QD	-11.9	± 10.00
JNJ-77242113 50 mg QD	-15.3	± 11.41
JNJ-77242113 25 mg BID	-13.3	± 11.08
JNJ-77242113 100 mg QD	-14.6	± 14.03
JNJ-77242113 100 mg BID	-21.0	± 13.74

Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 16 Secondary · Baseline (Week 0) and Week 16

Change from baseline in PSSD symptoms scores at Week 16 was reported. PSSD was a patient-reported outcome (PRO) questionnaire designed to measure severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily symptom score when at least 3 items (\>=5

Group	Value	95% CI
Placebo	-0.8	± 29.59
JNJ-77242113 25 mg QD	-35.8	± 29.22
JNJ-77242113 50 mg QD	-36.7	± 29.95
JNJ-77242113 25 mg BID	-34.0	± 29.19
JNJ-77242113 100 mg QD	-29.4	± 28.28
JNJ-77242113 100 mg BID	-44.0	± 31.22

Change From Baseline in PSSD Signs Score at Week 16 Secondary · Baseline (Week 0) and Week 16

Change from baseline in PSSD sign scores at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily sign score when at least 3 items (\>=50 percentage of 6 items) on these scal

Group	Value	95% CI
Placebo	-6.2	± 22.38
JNJ-77242113 25 mg QD	-38.6	± 27.55
JNJ-77242113 50 mg QD	-42.7	± 28.70
JNJ-77242113 25 mg BID	-41.8	± 27.78
JNJ-77242113 100 mg QD	-41.9	± 28.65
JNJ-77242113 100 mg BID	-51.1	± 26.01

Percentage of Participants Who Achieved PSSD Symptoms Score Equal to (=) 0 at Week 16 Among Participants With a Baseline Symptoms Score Greater Than or Equal to (>=) 1 Secondary · Baseline (Week 0), Week 16

The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily symptom score when at least 3 items (\>=50 percentage of 5 items) on these scales are answered. The average value was converted in

Group	Value	95% CI
Placebo	0
JNJ-77242113 25 mg QD	16.3
JNJ-77242113 50 mg QD	23.8
JNJ-77242113 25 mg BID	17.1
JNJ-77242113 100 mg QD	27.9
JNJ-77242113 100 mg BID	26.2

Percentage of Participants Who Achieved PSSD Sign Score = 0 at Week 16 Among Participants With a Baseline Sign Score >=1 Secondary · Baseline (Week 0) , Week 16

The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily sign score when at least 3 items (\>=50 percentage of 6 items) on these scales are answered. The average value was converted into

Group	Value	95% CI
Placebo	0
JNJ-77242113 25 mg QD	2.3
JNJ-77242113 50 mg QD	14.0
JNJ-77242113 25 mg BID	9.8
JNJ-77242113 100 mg QD	16.3
JNJ-77242113 100 mg BID	14.3

Percentage of Participants Who Achieved a Dermatological Life Quality Index (DLQI) of 0 or 1 at Week 16 Among Participants With Baseline DLQI Score Greater Than (>) 1 Secondary · Baseline (Week 0), Week 16

The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score i

Group	Value	95% CI
Placebo	2.4
JNJ-77242113 25 mg QD	27.9
JNJ-77242113 50 mg QD	37.2
JNJ-77242113 25 mg BID	30.0
JNJ-77242113 100 mg QD	55.8
JNJ-77242113 100 mg BID	43.9

Adverse events — posted to ClinicalTrials.gov

Time frame: From Week 0 through Week 20. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/43 (0%)

Deaths: 0/43

JNJ-77242113 25 mg QD

Serious: 0/43 (0%)

Deaths: 0/43

JNJ-77242113 50 mg QD

Serious: 1/43 (2%)

Deaths: 0/43

JNJ-77242113 25 mg BID

Serious: 0/41 (0%)

Deaths: 0/41

JNJ-77242113 100 mg QD

Serious: 2/43 (5%)

Deaths: 0/43

JNJ-77242113 100 mg BID

Serious: 0/42 (0%)

Deaths: 0/42

Serious adverse events (3 terms)

Reaction	System	Placebo	JNJ-77242113 25 mg QD	JNJ-77242113 50 mg QD	JNJ-77242113 25 mg BID	JNJ-77242113 100 mg QD	JNJ-77242113 100 mg BID
Covid-19	Infections and infestations	—	—	—	—	—	—
Infected Cyst	Infections and infestations	—	—	—	—	—	—
Suicide Attempt	Psychiatric disorders	—	—	—	—	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Placebo	JNJ-77242113 25 mg QD	JNJ-77242113 50 mg QD	JNJ-77242113 25 mg BID	JNJ-77242113 100 mg QD	JNJ-77242113 100 mg BID
Covid-19	Infections and infestations	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Upper Respiratory Tract Infection	Infections and infestations	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—

Most-reported serious reactions: Covid-19, Infected Cyst, Suicide Attempt.

Data from ClinicalTrials.gov NCT05223868 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. An Oral Interleukin-23-Receptor Antagonist Peptide for Plaque Psoriasis.
   Bissonnette R, Pinter A, Ferris LK, Gerdes S, et al · · 2024 · cited 47× · PMID 38324484 · DOI 10.1056/nejmoa2308713
2. New and Emerging Oral/Topical Small-Molecule Treatments for Psoriasis.
   Carmona-Rocha E, Rusiñol L, Puig L. · · 2024 · cited 28× · PMID 38399292 · DOI 10.3390/pharmaceutics16020239
3. Emerging Oral Therapies for the Treatment of Psoriasis: A Review of Pipeline Agents.
   Drakos A, Torres T, Vender R. · · 2024 · cited 21× · PMID 38258121 · DOI 10.3390/pharmaceutics16010111
4. A Review of the Clinical Trial Landscape in Psoriasis: An Update for Clinicians.
   Drakos A, Vender R. · · 2022 · cited 15× · PMID 36319883 · DOI 10.1007/s13555-022-00840-9
5. Translational Pharmacokinetics of Icotrokinra, a Targeted Oral Peptide that Selectively Blocks Interleukin-23 Receptor and Inhibits Signaling.
   Knight B, Tammara B, Modi NB, Dallas S, et al · · 2025 · cited 7× · PMID 40629250 · DOI 10.1007/s13555-025-01454-7
6. Oral Peptide Therapeutics as an Emerging Treatment Modality in Immune-Mediated Inflammatory Diseases: A Narrative Review.
   Stein Gold L, Eyerich K, Merola JF, Torres J, et al · · 2025 · cited 7× · PMID 40439953 · DOI 10.1007/s12325-025-03213-8
7. Icotrokinra induces early and sustained pharmacodynamic responses in phase IIb study of patients with moderate-to-severe psoriasis.
   Strawn D, Krueger JG, Bissonnette R, Eyerich K, et al · · 2025 · cited 2× · PMID 41424381 · DOI 10.1172/jci.insight.193563
8. Biologics and small molecules for psoriasis: current and future progress.
   Potestio L, Tommasino N, D'Agostino M, Esposito V, et al · · 2025 · cited 1× · PMID 41312187 · DOI 10.7573/dic.2025-8-4