A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis
- Registration Number
- NCT05364554
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 227
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 4: JNJ-77242113 Dose 1 Twice Daily (BID) JNJ-77242113 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. Group 1: JNJ-77242113 Dose 1 Once Daily (QD) JNJ-77242113 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. Group 6: JNJ-77242113 Dose 3 QD JNJ-77242113 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. Group 2: JNJ-77242113 Dose 2 QD JNJ-77242113 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. Group 3: JNJ-77242113 Dose 3 QD JNJ-77242113 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. Group 5: JNJ-77242113 Dose 3 BID JNJ-77242113 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 36 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in PASI Total Score at Week 36 Baseline and 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.
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 36 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).
Percentage of Participants Achieving PASI 100 Score at Week 36 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.
Change from Baseline in PSSD Signs Score at Week 36 Baseline and 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.
Number of Participants with Serious Adverse Events (SAEs) Up to Week 40 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.
Percentage of Participants Achieving PASI 90 Score at Week 36 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.
Percentage of Participants Achieving PSSD Signs Score=0 at Week 36 Among Participants With a Baseline (in the Originating Study) Signs Score >=1 Week 36 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.
Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 36 Baseline and 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.
Percentage of Participants Achieving PSSD Symptoms Score=0 at Week 36 Among Participants With a Baseline (in the Originating Study) Symptoms Score >=1 Week 36 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.
Number of Participants with Adverse Events (AEs) Up to Week 40 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.
Trial Locations
- Locations (59)
Pacific Skin Institute
🇺🇸Sacramento, California, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Forcare Clinical Research Inc
🇺🇸Tampa, Florida, United States
Arlington Dermatology
🇺🇸Rolling Meadows, Illinois, United States
Indiana Clinical Trial Center
🇺🇸Plainfield, Indiana, United States
Hamzavi Dermatology
🇺🇸Fort Gratiot, Michigan, United States
Vivida Dermatology
🇺🇸Las Vegas, Nevada, United States
Windsor Dermatology, PC
🇺🇸East Windsor, New Jersey, United States
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
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
Wro Medica
🇵🇱Wroclaw, Poland
Hosp. Univ. Germans Trias I Pujol
🇪🇸Barcelona, Spain
Hosp. Univ. 12 de Octubre
🇪🇸Madrid, Spain
Hosp. Univ. I Politecni La Fe
🇪🇸Valencia, Spain
Hosp. de Manises
🇪🇸Valencia, Spain
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, Taiwan
Guys and St Thomas NHS Foundation Trust
🇬🇧London, United Kingdom
Niesmann & Othlinghaus GbR
🇩🇪Bochum, Germany
Rosenpark Research GmbH
🇩🇪Darmstadt, Germany
Universitatsklinikum Frankfurt
🇩🇪Frankfurt am Main, Germany
Nomura Dermatology Clinic
🇯🇵Yokohama, Japan
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Nzoz Zdrowie Osteo-Medic
🇵🇱Bialystok, Poland
University of Pittsburgh Department of Dermatology
🇺🇸Pittsburgh, Pennsylvania, United States
Modern Research Associates
🇺🇸Dallas, Texas, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
Dermatrials Research
🇨🇦Hamilton, Ontario, Canada
Alliance Clinical Trials
🇨🇦Waterloo, Ontario, Canada
XLR8 Medical Research
🇨🇦Windsor, Ontario, Canada
Innovaderm Research Inc.
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Le Mans
🇫🇷Le Mans, France
Hopital Charles Nicolle
🇫🇷Rouen, France
HIA Sainte Anne
🇫🇷Toulon, France
Fachklinik Bad Bentheim
🇩🇪Bad Bentheim, Germany
ISA - Interdisciplinary Study Association GmbH
🇩🇪Berlin, Germany
CRS Clinical Research Services Berlin GmbH
🇩🇪Berlin, 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, Germany
Takagi Dermatological Clinic
🇯🇵Obihiro-shi, Japan
Kume Clinic
🇯🇵Sakai City, Japan
Sapporo Skin Clinic
🇯🇵Sapporo, Japan
Shizuoka General Hospital
🇯🇵Shizuoka, Japan
Shirasaki Dermatology Clinic
🇯🇵Takaoka, Japan
Toyama Prefectural Central Hospital
🇯🇵Toyama, Japan
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
KyungHee University Hospital
🇰🇷Seoul, Korea, Republic of
University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, United Kingdom