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

Plaque Psoriasis Clinical Trial

— FRONTIER 1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05223868
• Other study ID #: CR109138
• Secondary ID: 2021-003700-4177
• Status: Completed
• Phase: Phase 2
• Start date: February 3, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: January 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• JNJ-77242113
JNJ-77242113 tablet will be administered orally.
• Placebo
Placebo tablet will be administered orally.

Locations

Country	Name	City	State
Canada	Dermatrials Research	Hamilton	Ontario
Canada	Innovaderm Research	Montreal	Quebec
Canada	Alliance Clinical Trials	Waterloo	Ontario
Canada	XLR8 Medical Research	Windsor	Ontario
France	Centre Hospitalier Le Mans	Le Mans
France	Hopital Charles Nicolle	Rouen
France	HIA Sainte Anne	Toulon
Germany	Fachklinik Bad Bentheim	Bad Bentheim
Germany	Charite - Universitaetsmedizin Berlin (CCM)	Berlin
Germany	ISA - Interdisciplinary Study Association GmbH	Berlin
Germany	Rothhaar Studien GmbH	Berlin
Germany	Niesmann & Othlinghaus GbR	Bochum
Germany	Rosenpark Research GmbH	Darmstadt
Germany	Universitatsklinikum Frankfurt	Frankfurt am Main
Germany	Derma-Study-Center Friedrichshafen GmbH	Friedrichshafen
Germany	MensingDerma research GmbH	Hamburg
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Universitatsklinikum Schleswig Holstein Kiel	Kiel
Germany	Universitätsklinikum Leipzig AÖR	Leipzig
Germany	Dermatologische Gemeinschaftspraxis	Mahlow
Germany	Hautarztpraxis	Witten
Japan	Yamanashi Prefectural Central Hospital	Kofu
Japan	Miyata Dermatology Clinic	Matsudo
Japan	Takagi Dermatology Clinic	Obihiro-shi
Japan	Kume Clinic	Osaka Fu
Japan	Sapporo Skin Clinic	Sapporo
Japan	Shizuoka Prefectural General Hospital	Shizuoka
Japan	Shirasaki Dermatology Clinic	Takaoka
Japan	Kumamoto Kenhoku Hospital	Tamana
Japan	Toyama Prefectural Central Hospital	Toyama
Japan	Nomura Dermatology Clinic	Yokohama
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	KyungHee University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Poland	Nzoz Zdrowie Osteo-Medic	Bialystok
Poland	Dermed Centrum Medyczne Sp. z o.o	Lodz
Poland	DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski s.c.	Osielsko
Poland	Klinika Ambroziak Estederm Sp. z o.o	Warsaw
Poland	Wromedica	Wroclaw
Spain	Hosp. Univ. Germans Trias I Pujol	Barcelona
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Provincial de Pontevedra	Pontevedra
Spain	Hosp. de Manises	Valencia
Spain	Hosp. Univ. I Politecni La Fe	Valencia
Taiwan	Chang Gung Memorial Hospital	Kaohsiung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	Chang-Gung Memorial Hospital, LinKou Branch	Taoyuan
United Kingdom	Castle Hill Hospital	Cottingham
United Kingdom	Russell's Hall Hospital	Dudley
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton
United Kingdom	Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital	Wakefield
United States	Atlanta Dermatology, Vein & Research Center	Alpharetta	Georgia
United States	Modern Research Associates	Dallas	Texas
United States	Windsor Dermatology, PC	East Windsor	New Jersey
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Center for Clinical Studies	Houston	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Vivida Dermatology	Las Vegas	Nevada
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Renstar Medical Research	Ocala	Florida
United States	Austin Institute for Clinical Research	Pflugerville	Texas
United States	Medical Dermatology Specialists	Phoenix	Arizona
United States	University of Pittsburgh Department of Dermatology	Pittsburgh	Pennsylvania
United States	Indiana Clinical Trial Center	Plainfield	Indiana
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	DermAssociates, PC	Rockville	Maryland
United States	Arlington Dermatology	Rolling Meadows	Illinois
United States	Pacific Skin Institute	Sacramento	California
United States	Dermatology Associates	Seattle	Washington
United States	Premier Clinical Research	Spokane	Washington
United States	Forcare Clinical Research, Inc.	Tampa	Florida
United States	Center for Clinical Studies	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16	Percentage of participants achieving PASI 75 score (greater than or equal to [>=] 75 percentage [%] improvement from baseline in PASI) at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Week 16
Secondary	Change from Baseline in PASI Total Score at Week 16	Change from baseline in PASI total score at Week 16 will be reported.	From baseline to Week 16
Secondary	Percentage of Participants Achieving PASI 90 Score at Week 16	Percentage of participants achieving PASI 90 score (>=90% improvement from baseline in PASI) at Week 16 will be reported.	Week 16
Secondary	Percentage of Participants Achieving PASI 100 Score at Week 16	Percentage of participants achieving PASI 100 score (100% improvement from baseline in PASI) at Week 16 will be reported.	Week 16
Secondary	Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16	Percentage of participants who achieve an IGA score of cleared (0) or minimal (1) at Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 16
Secondary	Percentage of Participants Achieving an IGA Score of Cleared (0) at Week 16	Percentage of participants who achieve an IGA score of cleared (0) at Week 16 will be reported.	Week 16
Secondary	Change from Baseline in Body Surface Area (BSA) at Week 16	Change from baseline in BSA at Week 16 will be reported. Body Surface Area is a commonly used measure of severity of skin disease. It is defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis).	From baseline to Week 16
Secondary	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 will be reported. The PSSD includes patient-reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two subscores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.	From baseline to Week 16
Secondary	Change from Baseline in PSSD Signs Score at Week 16	Change from baseline in PSSD signs score at Week 16 will be reported.	From baseline to Week 16
Secondary	Percentage of Participants Achieving PSSD Symptoms Score=0 at Week 16 in Participants with a Baseline Symptoms Score >=1	Percentage of participants achieving PSSD symptoms score=0 at Week 16 in participants with a baseline symptoms score >=1 will be reported.	Week 16
Secondary	Percentage of Participants Achieving PSSD Sign Score=0 at Week 16 in Participants with a Baseline Sign Score >=1	Percentage of participants achieving PSSD sign score=0 at Week 16 in participants with a baseline sign score >=1 will be reported.	Week 16
Secondary	Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16 in Participants with Baseline DLQI Score >1	The DLQI is a dermatology-specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It is a 10-item questionnaire that assesses HRQoL over the past 7 days and in addition to evaluating overall HRQoL, can 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. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL.	Week 16
Secondary	Change from Baseline in Patient-reported Outcomes Measurement Information System (PROMIS-29) Domain Score at Week 16	Change from baseline in PROMIS-29 domain scores at week 16 will be reported. The PROMIS-29 is a 29-item generic HRQoL instrument assessing 7 PROMIS domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities) with 4 questions for each domain. These questions are ranked on a 5-point Likert scale. There is also a numerical rating scale that ranges from 0 (No pain) to 10 (Worst pain imaginable) for pain intensity. The raw domain scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10. Higher scores on anxiety, depression, fatigue, sleep disturbance, and pain interference indicate more severe symptoms. Higher scores on physical function and social participation indicate better health outcomes.	From baseline to Week 16
Secondary	Percentage of Participants Who Achieve >= 5-Point Improvement from Baseline in PROMIS-29 Domain Score at Week 16	Percentage of participants who achieve >=5-point improvement from baseline in PROMIS-29 domain score at Week 16 will be reported.	Week 16
Secondary	Number of Participants with Adverse Events (AEs)	An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to 24 weeks
Secondary	Number of Participants with Serious Adverse Events (SAEs)	SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.	Up to 24 weeks