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

Plaque Psoriasis Clinical Trial

— FRONTIER 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05364554
• Other study ID #: CR109155
• Secondary ID: 2021-004320-1677
• Status: Completed
• Phase: Phase 2
• Start date: June 10, 2022
• Est. completion date: September 29, 2023

Study information

• Verified date: November 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: September 29, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Canada	Dermatrials Research	Hamilton	Ontario
Canada	Innovaderm Research Inc.	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	CRS Clinical Research Services Berlin GmbH	Berlin
Germany	ISA - Interdisciplinary Study Association 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	Gemeinschaftspraxis Scholz/Sebastian/Schilling	Mahlow
Germany	Hautarztpraxis	Witten
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	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	Warszawa
Poland	Wromedica	Wroclaw
Spain	Hosp. Univ. Germans Trias I Pujol	Barcelona
Spain	Hosp. Univ. 12 de Octubre	Madrid
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	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton
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	Vivida Dermatology	Las Vegas	Nevada
United States	Renstar Medical Research	Ocala	Florida
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	Arlington Dermatology	Rolling Meadows	Illinois
United States	Pacific Skin Institute	Sacramento	California
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 36	Percentage of participants achieving PASI 75 score (greater than or equal to [>=] 75 percent [%] improvement in PASI from baseline of the originating study [77242113PSO2001]) at Week 36 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 36
Secondary	Percentage of Participants Achieving PASI 90 Score at Week 36	Percentage of participants achieving PASI 90 score (>=90% improvement in PASI from baseline of the originating study [77242113PSO2001]) at Week 36 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 36
Secondary	Percentage of Participants Achieving PASI 100 Score at Week 36	Percentage of participants achieving PASI 100 score (>=100% improvement in PASI from baseline of the originating study [77242113PSO2001]) at Week 36 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 36
Secondary	Change From Baseline in PASI Total Score at Week 36	Change from baseline of the originating study (77242113PSO2001) in PASI total score at Week 36 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.	Baseline and Week 36
Secondary	Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 36	Percentage of participants who achieve an IGA score of cleared (0) or minimal (1) at Week 36 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 36
Secondary	Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 36	Change from baseline of originating Study (77242113PSO2001) in PSSD symptoms scores at Week 36 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 sub scores 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.	Baseline and Week 36
Secondary	Change from Baseline in PSSD Signs Score at Week 36	Change from baseline of originating study (77242113PSO2001) in PSSD signs score at Week 36 will be reported. The PSSD includes 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 sub scores 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.	Baseline and Week 36
Secondary	Percentage of Participants Achieving PSSD Symptoms Score=0 at Week 36 Among Participants With a Baseline (in the Originating Study) Symptoms Score >=1	Percentage of participants achieving PSSD symptoms score=0 at Week 36 among participants with a baseline (in the originating study 77242113PSO2001) symptoms score >=1 will be reported. The PSSD includes 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 sub scores 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.	Week 36
Secondary	Percentage of Participants Achieving PSSD Signs Score=0 at Week 36 Among Participants With a Baseline (in the Originating Study) Signs Score >=1	Percentage of participants achieving PSSD signs score=0 at week 36 among participants with a baseline (in the originating study) signs score >=1 will be reported. The PSSD includes 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 sub scores 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.	Week 36
Secondary	Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.	Up to Week 40
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 Week 40