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

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.

Study Overview

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

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 psoriatic arthritis (PsA) and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. The total duration of this study is up to 24 weeks which includes a screening period of less than or equal to (<=) 4 weeks, a 16-week treatment period, and a 4-week safety follow-up period. Safety will be assessed by adverse events (AEs), clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations.

• Study Type: Interventional
• Enrollment (Actual): 255
• 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, N8W 1E6
      • XLR8 Medical Research
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Innovaderm Research
• France
  • Le Mans, France, 72037
    • Centre Hospitalier Le Mans
  • Rouen, France, 76031
    • Hopital Charles Nicolle
  • Toulon, France, 83800
    • HIA Sainte Anne
• Germany
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim
  • Berlin, Germany, 10783
    • Rothhaar Studien GmbH
  • Berlin, Germany, 10789
    • ISA - Interdisciplinary Study Association GmbH
  • Berlin, Germany, 10117
    • Charite - Universitaetsmedizin Berlin (CCM)
  • Bochum, Germany, 44793
    • Niesmann & Othlinghaus GbR
  • Darmstadt, Germany, 64283
    • Rosenpark Research GmbH
  • Frankfurt am Main, Germany, 60590
    • Universitatsklinikum 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
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig AöR
  • Mahlow, Germany, 15831
    • Dermatologische Gemeinschaftspraxis
  • Witten, Germany, 58453
    • Hautarztpraxis
• Japan
  • Kofu, Japan, 400-8506
    • Yamanashi Prefectural Central Hospital
  • Matsudo, Japan, 271-0092
    • Miyata Dermatology Clinic
  • 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
  • Tamana, Japan, 865-0005
    • Kumamoto Kenhoku Hospital
  • 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
  • Pontevedra, Spain, 36001
    • Hosp. Provincial de Pontevedra
  • 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, 70403
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital
  • Taoyuan District, Taiwan, 333
    • Chang-Gung Memorial Hospital, LinKou Branch
• United Kingdom
  • Cottingham, United Kingdom, HU16 5JQ
    • Castle Hill Hospital
  • Dudley, United Kingdom, DY1 2HQ
    • Russell's Hall Hospital
  • London, United Kingdom, SE1 9RT
    • Guys and St Thomas NHS Foundation Trust
  • Southampton, United Kingdom, SO16 6YD
    • University Hospital Southampton NHS Foundation Trust
  • Wakefield, United Kingdom, WF1 4DG
    • Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Medical Dermatology Specialists
  • 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
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Atlanta Dermatology, Vein & Research Center
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group LLC
    • Plainfield, Indiana, United States, 46168
      • Indiana Clinical Trial Center
  • Maryland
    • Rockville, Maryland, United States, 20850
      • DermAssociates, PC
  • 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
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Clinical Research
  • Washington
    • Seattle, Washington, United States, 98101
      • Dermatology Associates
    • 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:

• Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 6 months prior to the first administration of study intervention
• Participant be a candidate for phototherapy or systemic treatment for plaque psoriasis
• Participant has a total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
• Participant has a total Psoriasis area and severity index (PASI) >=12 at screening and baseline
• Participant has a total Investigator global assessment (IGA) >=3 at screening and baseline

Exclusion Criteria:

• Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
• Participant has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• Participant have previously received any other therapeutic agent directly targeted to interleukin 23 receptor (IL-23R) (including but not limited to guselkumab, tildrakizumab, or risankizumab)
• Participant has received any therapeutic agent directly targeted to interleukin 17 receptor (IL-17) or interleukin 12/23 receptor (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received anti-tumor necrosis factor [TNF]-alpha biologic therapy (including, but not limited to adalimumab) within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention
• Participant has received agents that deplete B cells (including, but not limited to, rituximab, or alemtuzumab) within 26 weeks of the first administration of study intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: 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) and Placebo; 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.	Drug: JNJ-77242113; JNJ-77242113 tablet will be administered orally.; Drug: Placebo; Placebo tablet will be administered orally.
Experimental: Group 2: JNJ-77242113 Dose 2 QD and Placebo; Participants will receive JNJ-77242113 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.	Drug: JNJ-77242113; JNJ-77242113 tablet will be administered orally.; Drug: Placebo; Placebo tablet will be administered orally.
Experimental: Group 3: JNJ-77242113 Dose 3 QD and Placebo; Participants will receive JNJ-77242113 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.	Drug: JNJ-77242113; JNJ-77242113 tablet will be administered orally.; Drug: Placebo; Placebo tablet will be administered orally.
Experimental: Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) and Placebo; Participants will receive JNJ-77242113 Dose 1 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.	Drug: JNJ-77242113; JNJ-77242113 tablet will be administered orally.; Drug: Placebo; Placebo tablet will be administered orally.
Experimental: Group 5: JNJ-77242113 Dose 3 BID and Placebo; Participants will receive JNJ-77242113 Dose 3 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.	Drug: JNJ-77242113; JNJ-77242113 tablet will be administered orally.; Drug: Placebo; Placebo tablet will be administered orally.
Placebo Comparator: Group 6: Placebo; Participants will receive placebo BID from Week 0 through Week 16.	Drug: Placebo; Placebo tablet will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in PASI Total Score at 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 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
Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI (PASI-90) at 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 (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
Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI (PASI-100) at 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 (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
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) 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; 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). Higher score indicated more severe disease.	At Week 16
Percentage of Participants Who Achieved an IGA Score of Cleared (0) 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 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 Week 16
Change From Baseline in Body Surface Area (BSA) at 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.	Baseline (Week 0) and Week 16
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at 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 (>=50 percentage of 5 items) on these scales are 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. 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) and Week 16
Change From Baseline in PSSD Signs Score at 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 scales are 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 the first study drug administration date.	Baseline (Week 0) and Week 16
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	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 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 the first study drug administration date.	Baseline (Week 0), Week 16
Percentage of Participants Who Achieved PSSD Sign Score = 0 at Week 16 Among Participants With a Baseline Sign 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 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 the first study drug administration date.	Baseline (Week 0) , Week 16
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	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 indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. 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
Change From Baseline in Domain Scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29) at Week 16	PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score= worst pain. Each domain included 4 items, plus a single pain intensity item totaling 29 items. Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score). Higher PROMIS T-score=more of concept being measured i.e. higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles= better functioning. Baseline: closest measurement taken prior to/at the time of first study drug administration date.	Baseline (Week 0) and Week 16
Percentage of Participants Who Achieved at Least a 5-point Improvement From Baseline in Each PROMIS-29 Domain at Week 16	PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score=worst pain. Each domain includes 4 items, plus a single pain intensity item totaling 29 items. Raw score of each PROMIS domain was converted into a standardized score with mean of 50; SD of 10 (T-Score). Higher PROMIS T-score= more of the concept being measured i.e. higher scores in anxiety, depression, fatigue, pain interference and sleep disturbance) indicated worse symptoms, higher scores in physical function and social roles= better functioning. Baseline: closest measurement taken prior to/at the time of first study drug administration date.	Baseline (Week 0), Week 16
Number of Participants With Treatment-emergent Adverse Event (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 event that occurred at or after the initial administration of study agent.	From Week 0 through Week 20

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

• Bissonnette R, Pinter A, Ferris LK, Gerdes S, Rich P, Vender R, Miller M, Shen YK, Kannan A, Li S, DeKlotz C, Papp K. An Oral Interleukin-23-Receptor Antagonist Peptide for Plaque Psoriasis. N Engl J Med. 2024 Feb 8;390(6):510-521. doi: 10.1056/NEJMoa2308713.
• 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): February 3, 2022
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: CR109138; 2021-003700-41 (EudraCT Number); 77242113PSO2001 (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