Psoriasis Clinical Trial
A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis
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.
Full 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.
Eligibility Criteria
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
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There are 60 Locations for this study
Sacramento California, 95815, United States
Ocala Florida, 34470, United States
Tampa Florida, 33613, United States
Rolling Meadows Illinois, 60008, United States
Plainfield Indiana, 46168, United States
Fort Gratiot Michigan, 48059, United States
Las Vegas Nevada, 89119, United States
East Windsor New Jersey, 08520, United States
Portland Oregon, 97210, United States
Pittsburgh Pennsylvania, 15213, United States
Dallas Texas, 75231, United States
Houston Texas, 77004, United States
Webster Texas, 77598, United States
Spokane Washington, 99202, United States
Hamilton Ontario, L8N 1, Canada
Waterloo Ontario, N2J 1, Canada
Windsor Ontario, N8T 1, Canada
Montreal Quebec, H2H2B, Canada
Le Mans , 72037, France
Rouen , 76031, France
Toulon , 83800, France
Bad Bentheim , 48455, Germany
Berlin , 10789, Germany
Berlin , 13627, Germany
Bochum , 44793, Germany
Darmstadt , 64283, Germany
Frankfurt am Main , 60590, Germany
Friedrichshafen , 88045, Germany
Hamburg , 22391, Germany
Heidelberg , 69120, Germany
Kiel , 24105, Germany
Mahlow , 15831, Germany
Witten , 58453, Germany
Obihiro-shi , 080-0, Japan
Osaka Fu , 593-8, Japan
Sapporo , 060-0, Japan
Shizuoka , 420-8, Japan
Takaoka , 933-0, Japan
Toyama , 930-8, Japan
Yokohama , 221-0, Japan
Busan , 49241, Korea, Republic of
Gyeonggi-do , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05030, Korea, Republic of
Seoul , 102-1, Korea, Republic of
Bialystok , 15-35, Poland
Lodz , 90-26, Poland
Osielsko , 86031, Poland
Warszawa , 02-95, Poland
Wroclaw , 51-68, Poland
Barcelona , 08916, Spain
Madrid , 28041, Spain
Valencia , 46026, Spain
Valencia , 46940, Spain
Kaohsiung , 83342, Taiwan
Tainan , 704, Taiwan
Taipei City , 10048, Taiwan
Taoyuan , 333, Taiwan
London , SE1 9, United Kingdom
Southampton , SO16 , United Kingdom
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