A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis (FRONTIER 2)

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

The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: JNJ-77242113

Detailed Description

The populations of people living with moderate to severe psoriasis is approximately 3.5 billion which are mostly managed with topical and conventional therapies. JNJ-77242113, investigational drug, targets the immune responses in the body and skin which impacts diseases, such as psoriasis and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. This is a long-term extension study of JNJ-77242113 in eligible participants who have completed the Week 16 visit of the originating Study 77242113PSO2001. The total duration of this study will be up to 40 weeks which will include a 36-week treatment period, and a 4-week safety follow-up period after the last study intervention administration. Safety will be assessed by adverse events (AEs), clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations.

• Study Type: Interventional
• Enrollment (Actual): 227
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Dermatrials Research
    • Waterloo, Ontario, Canada, N2J 1C4
      • Alliance Clinical Trials
    • Windsor, Ontario, Canada, N8T 1E6
      • XLR8 Medical Research
  • Quebec
    • Montreal, Quebec, Canada, H2H2B5
      • Innovaderm Research Inc.
• France
  • Le Mans, France, 72037
    • Centre Hospitalier Le Mans
  • Rouen, France, 76031
    • Hôpital Charles Nicolle
  • Toulon, France, 83800
    • Hia Sainte Anne
• Germany
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim
  • Berlin, Germany, 10789
    • ISA - Interdisciplinary Study Association GmbH
  • Berlin, Germany, 13627
    • CRS Clinical Research Services Berlin GMBH
  • Bochum, Germany, 44793
    • Niesmann & Othlinghaus GbR
  • Darmstadt, Germany, 64283
    • Rosenpark Research GmbH
  • Frankfurt am Main, Germany, 60590
    • Universitätsklinikum Frankfurt
  • Friedrichshafen, Germany, 88045
    • Derma-Study-Center Friedrichshafen GmbH
  • Hamburg, Germany, 22391
    • MensingDerma Research GmbH
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg
  • Kiel, Germany, 24105
    • Universitatsklinikum Schleswig Holstein Kiel
  • Mahlow, Germany, 15831
    • Gemeinschaftspraxis Scholz/Sebastian/Schilling
  • Witten, Germany, 58453
    • Hautarztpraxis
• Japan
  • Obihiro-shi, Japan, 080-0013
    • Takagi Dermatological Clinic
  • Sakai, Japan, 593 8324
    • Kume Clinic
  • Sapporo, Japan, 060-0063
    • Sapporo Skin Clinic
  • Shizuoka, Japan, 420-8527
    • Shizuoka General Hospital
  • Takaoka, Japan, 933-0871
    • Shirasaki dermatology clinic
  • Toyama, Japan, 930 8550
    • Toyama Prefectural Central Hospital
  • Yokohama, Japan, 221 0825
    • Nomura Dermatology Clinic
• Poland
  • Bialystok, Poland, 15-351
    • Nzoz Zdrowie Osteo-Medic
  • Lodz, Poland, 90-265
    • Dermed Centrum Medyczne Sp z o o
  • Osielsko, Poland, 86031
    • Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
  • Warsaw, Poland, 02-953
    • Klinika Ambroziak Estederm Sp. z o.o
  • Wroclaw, Poland, 51-685
    • Wro Medica
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Gyeonggi-do, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05030
    • Konkuk University Medical Center
  • Seoul, South Korea, 102-1703
    • KyungHee University Hospital
• Spain
  • Barcelona, Spain, 08916
    • Hosp. Univ. Germans Trias I Pujol
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Valencia, Spain, 46940
    • Hosp. de Manises
  • Valencia, Spain, 46026
    • Hosp. Univ. I Politecni La Fe
• Taiwan
  • Kaohsiung City, Taiwan, 83342
    • Chang Gung Memorial Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 333
    • Chang-Gung Memorial Hospital, LinKou Branch
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Guys and St Thomas NHS Foundation Trust
  • Southampton, United Kingdom, SO16 6YD
    • University Hospital Southampton NHS Foundation Trust
• United States
  • California
    • Sacramento, California, United States, 95815
      • Pacific Skin Institute
  • Florida
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Tampa, Florida, United States, 33613
      • Forcare Clinical Research Inc
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Indiana Clinical Trial Center
  • Michigan
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Vivida Dermatology
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Windsor Dermatology, PC
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Department of Dermatology
  • Texas
    • Dallas, Texas, United States, 75231
      • Modern Research Associates
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Must have completed the Week 16 visit in Protocol 77242113PSO2001
• In the opinion of the investigator, may benefit from inclusion in this long term extension (LTE) study
• Must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study
• Must agree to discontinue all topical therapies that could affect psoriasis or the psoriasis area severity index (PASI) or investigator's global assessment (IGA) evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention
• Agree not to receive a live virus or live bacterial vaccination during the study, or within 4 weeks after the last administration of study intervention

Exclusion Criteria:

• Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason
• Has received any biologic therapy or experimental therapy since completion of the originating study, 77242113PSO2001
• Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention
• Has received the bacille Calmette-Guerin (BCG) vaccine within 12 months of the first administration of study intervention
• Currently has hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or has other clinically active liver disease, or tests positive for HBsAg or anti-HCV

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: JNJ-77242113 Dose 1 Once Daily (QD); Participants originally randomized to JNJ-77242113 Dose 1 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 QD from Week 0 through Week 36 in this study.	Drug: JNJ-77242113; JNJ-77242113 tablet will be administered orally.
Experimental: Group 2: JNJ-77242113 Dose 2 QD; Participants originally randomized to JNJ-77242113 Dose 2 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 2 QD from Week 0 through Week 36 in this study.	Drug: JNJ-77242113; JNJ-77242113 tablet will be administered orally.
Experimental: Group 3: JNJ-77242113 Dose 3 QD; Participants originally randomized to JNJ-77242113 Dose 3 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.	Drug: JNJ-77242113; JNJ-77242113 tablet will be administered orally.
Experimental: Group 4: JNJ-77242113 Dose 1 Twice Daily (BID); Participants originally randomized to JNJ-77242113 Dose 1 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 BID from Week 0 through Week 36 in this study.	Drug: JNJ-77242113; JNJ-77242113 tablet will be administered orally.
Experimental: Group 5: JNJ-77242113 Dose 3 BID; Participants originally randomized to JNJ-77242113 Dose 3 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 BID from Week 0 through Week 36 in this study.	Drug: JNJ-77242113; JNJ-77242113 tablet will be administered orally.
Experimental: Group 6: JNJ-77242113 Dose 3 QD; Participants originally randomized to placebo in originating Study 77242113PSO2001 will receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.	Drug: JNJ-77242113; JNJ-77242113 tablet will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 75 Percent (%) Improvement From Baseline in Psoriasis Area Severity Index Score (PASI-75) at LTE Week 36	Percentage of participants who achieved >=75% improvement from baseline in PASI score at LTE Week 36 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, 4=very severe) and extent of involvement from 0 (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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.	Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI Score (PASI-90) at LTE Week 36	Percentage of participants who achieved >=90% improvement from baseline in PASI score at LTE Week 36 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In 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, 4=very severe) and extent of involvement from 0 (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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.	Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI Score (PASI-100) at LTE Week 36	Percentage of participants who achieved 100% improvement from baseline in PASI score at LTE Week 36 was reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: 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 (no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range on a scale of 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.	Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change From Baseline in PASI Total Score at LTE Week 36	Change from baseline in PASI total score at LTE Week 36 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 first study drug administration date in 77242113PSO2001 study.	Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at LTE Week 36	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; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.	At LTE Week 36 (52 weeks from originating study baseline)
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at LTE Week 36	Change from baseline in PSSD symptoms scores at LTE Week 36 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: 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 scales for severity. Items were averaged on the daily symptom score when at least 3 items (>=50 percentage of 5 items) on these scales were answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0=least severe and 100=most severe. Higher score indicated more severe disease. Baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.	Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change From Baseline in PSSD Signs Score at LTE Week 36	Change from baseline in PSSD sign scores at LTE Week 36 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 scales were answered. The average value was converted into 0-100 scoring, such that sign score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.	Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Who Achieved PSSD Symptoms Score Equal (=) 0 at LTE Week 36 Among Participants With a Baseline (Week 0 of the Originating Study) Symptoms Score >=1	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 is converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.	Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Achieving PSSD Signs Score=0 at Week 36 Among Participants With a Baseline (Week 0 of the Originating Study) Signs Score >=1	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 is converted into 0-100 scoring, such that sign score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.	Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TEAE was defined as any AE that occurred after receiving the treatment in originating study (77242113PSO2001). TEAEs and TESAEs that occurred during this study are reported.	From LTE Week 0 up to LTE Week 40

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

General Publications

• LaRoche JK, Lanier J, Alvarenga R, Collins M, Costelloe T, Chiau A, Whetherly H, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas. BMJ Open. 2025 Feb 19;15(2):e085364. doi: 10.1136/bmjopen-2024-085364.
• Strawn D, Krueger JG, Bissonnette R, Eyerich K, Ferris LK, Paller AS, Pinter A, Richards D, Chen EY, Paget K, Horowitz D, Parast R, Rusbuldt JJ, Sendecki J, Bhagat S, Tomsho LP, Chou CH, Polak ME, Keyes BE, Bozenhardt E, Xiong Y, Zhou W, DeKlotz C, Newbold P, Waterworth DM, Miller M, Ota T, Yang YW, Leung MW, Miller LS, Cuff CA, McRae B, Ruane D, Kannan AK. Icotrokinra induces early and sustained pharmacodynamic responses in phase IIb study of patients with moderate-to-severe psoriasis. JCI Insight. 2025 Dec 22;10(24):e193563. doi: 10.1172/jci.insight.193563. eCollection 2025 Dec 22.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: CR109155; 2021-004320-16 (EudraCT Number); 77242113PSO2002 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No