Psoriasis Clinical Trial
Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.
A long term study to demonstrate the Safety and Efficacy of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab Spondyloarthritis.
Subjects have rolled over from parent study, i.e., CLR_16_23, into the long-term extension study CLR_18_07.
The study has been open label post 1 year completion.
Subjects may be included in the study if they meet all of the following criteria:
Subject has provided written informed consent for this long-term extension study.
Subjects with PsA who met the inclusion criteria of the parent study and completed the parent study treatment period (e.g., up to Week 48 for the parent Phase 2 study, with return for the EoT assessment at Week 52).
No concomitant use of both leflunomide and methotrexate,
No history of active tuberculosis (TB) or symptoms of TB.
Subjects should be excluded from the study if they meet any of the following criteria:
New onset during the parent study of arthritic conditions other than the subject's original condition.
Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception, for example, a combination of the following: (1) oral contraceptive, depo-progesterone, or intrauterine device; and (2) a barrier method (condom or diaphragm). Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy). Contraceptive methods must be practiced upon entering the study and through 16 weeks after the last dose of IMP. If a subject discontinues prematurely, the contraceptive method must be practiced for 16 weeks following final administration of IMP.
Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 16 weeks after the last dose of IMP.
Subject has previously been enrolled in this long-term extension study.
Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject.
Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could cause continued treatment to be detrimental to the subject.
Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus during the parent study.
Subjects with a history of alcohol or drug abuse during the parent study.
Subject has a need for use of a live vaccine within 10 weeks of final anticipated dose of IMP for the long-term extension study.
Concomitant use of prohibited medications or use of commercially available or investigational biologic therapies (other than tildrakizumab) for PsO and/or PsA
Subjects who have been placed in an institution on official or judicial orders.
Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest may arise.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 66 Locations for this study
Glendale Arizona, 85306, United States
Phoenix Arizona, 85032, United States
Denver Colorado, 80230, United States
Wichita Kansas, 67207, United States
Lexington Kentucky, 40504, United States
Monroe Louisiana, 71203, United States
Lebanon New Hampshire, 03756, United States
Salisbury North Carolina, 28144, United States
Cincinnati Ohio, 45242, United States
Middleburg Heights Ohio, 44130, United States
Memphis Tennessee, 38119, United States
Seattle Washington, 98122, United States
Spokane Washington, 99204, United States
Ciudad Autonoma de Buenos Aires Buenos Aires, C1128, Argentina
Mar Del Plata Buenos Aires, 7600, Argentina
San Fernando Buenos Aires, 1646, Argentina
Budapest , 1036, Hungary
Budapest , 1062, Hungary
Kistarcsa , 2143, Hungary
Szolnok , 5000, Hungary
Mexico Distrito Federal, 06700, Mexico
Mexico City Mexico, City, 7760, Mexico
Monterrey Nuevo Leon, 64020, Mexico
San Luis Potosí San Luis Potosi, 78213, Mexico
San Luis Potosí San Luis Potosi, 78220, Mexico
Culiacán Sinaloa, 80000, Mexico
Mérida Yucatan, 97070, Mexico
Chihuahua , 31000, Mexico
Cuautitlán Izcalli , 54769, Mexico
Durango , 34080, Mexico
Kraków Malopolskie, 30-51, Poland
Białystok , 15-87, Poland
Bytom , 41-90, Poland
Elbląg , 82-30, Poland
Katowice , 40-08, Poland
Katowice , 40-28, Poland
Kraków , 30-00, Poland
Nowa Sól , 67-10, Poland
Poznan , 60-84, Poland
Sochaczew , 96-50, Poland
Warszawa , 02-69, Poland
Warszawa , 04-30, Poland
Wrocław , 51-68, Poland
Łódź , 90-26, Poland
Kemerovo Kemerovo Region, 65006, Russian Federation
Novosibirsk Novosibirsk Oblast, 63009, Russian Federation
Tomsk Tomsk Oblast, 63405, Russian Federation
Izhevsk , 42607, Russian Federation
Moscow , 11540, Russian Federation
Saint-Petersburg , 19608, Russian Federation
Smolensk , 21401, Russian Federation
Yaroslavl , 15000, Russian Federation
Yaroslavl , 15000, Russian Federation
Santiago De Compostela La Coruna, 15702, Spain
Málaga Malaga, 29730, Spain
Bilbao Vizcaya, 48013, Spain
Barcelona , 08034, Spain
Barcelona , 08035, Spain
Sevilla , 41010, Spain
Kharkiv , 61039, Ukraine
Kiev , 03151, Ukraine
Kyiv , 01023, Ukraine
Kyiv , 02091, Ukraine
Kyiv , 03110, Ukraine
Odesa , 65025, Ukraine
Vinnytsya , 21029, Ukraine
Zaporizhzhia , 69600, Ukraine
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.