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.

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

286

Study ID:

NCT03552276

Recruitment Status:

Completed

Sponsor:

Sun Pharmaceutical Industries Limited

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There are 66 Locations for this study

See Locations Near You

Site 25
Glendale Arizona, 85306, United States
Site 16
Phoenix Arizona, 85032, United States
Site 14
Denver Colorado, 80230, United States
Site 27
Wichita Kansas, 67207, United States
Site 23
Lexington Kentucky, 40504, United States
Site 20
Monroe Louisiana, 71203, United States
Site 26
Lebanon New Hampshire, 03756, United States
Site 24
Salisbury North Carolina, 28144, United States
Site 19
Cincinnati Ohio, 45242, United States
Site 17
Middleburg Heights Ohio, 44130, United States
Site 18
Memphis Tennessee, 38119, United States
Site 21
Seattle Washington, 98122, United States
Site 22
Spokane Washington, 99204, United States
Site 02
Ciudad Autonoma de Buenos Aires Buenos Aires, C1128, Argentina
Site 01
Mar Del Plata Buenos Aires, 7600, Argentina
Site 03
San Fernando Buenos Aires, 1646, Argentina
Site 32
Budapest , 1036, Hungary
Site 34
Budapest , 1062, Hungary
Site 33
Kistarcsa , 2143, Hungary
Site 31
Szolnok , 5000, Hungary
Site 09
Mexico Distrito Federal, 06700, Mexico
Site 05
Mexico City Mexico, City, 7760, Mexico
Site 06
Monterrey Nuevo Leon, 64020, Mexico
Site 13
San Luis Potosí San Luis Potosi, 78213, Mexico
Site 04
San Luis Potosí San Luis Potosi, 78220, Mexico
Site 07
Culiacán Sinaloa, 80000, Mexico
Site 12
Mérida Yucatan, 97070, Mexico
Site 11
Chihuahua , 31000, Mexico
Site 08
Cuautitlán Izcalli , 54769, Mexico
Site 10
Durango , 34080, Mexico
Site 45
Kraków Malopolskie, 30-51, Poland
Site 38
Białystok , 15-87, Poland
Site 47
Bytom , 41-90, Poland
Site 36
Elbląg , 82-30, Poland
Site 39
Katowice , 40-08, Poland
Site 40
Katowice , 40-28, Poland
Site 46
Kraków , 30-00, Poland
Site 48
Nowa Sól , 67-10, Poland
Site 42
Poznan , 60-84, Poland
Site 53
Sochaczew , 96-50, Poland
Site 50
Warszawa , 02-69, Poland
Site 52
Warszawa , 04-30, Poland
Site 51
Wrocław , 51-68, Poland
Site 43
Łódź , 90-26, Poland
Site 61
Kemerovo Kemerovo Region, 65006, Russian Federation
Site 58
Novosibirsk Novosibirsk Oblast, 63009, Russian Federation
Site 54
Tomsk Tomsk Oblast, 63405, Russian Federation
Site 56
Izhevsk , 42607, Russian Federation
Site 60
Moscow , 11540, Russian Federation
Site 57
Saint-Petersburg , 19608, Russian Federation
Site 62
Smolensk , 21401, Russian Federation
Site 55
Yaroslavl , 15000, Russian Federation
Site 59
Yaroslavl , 15000, Russian Federation
Site 67
Santiago De Compostela La Coruna, 15702, Spain
Site 65
Málaga Malaga, 29730, Spain
Site 68
Bilbao Vizcaya, 48013, Spain
Site 66
Barcelona , 08034, Spain
Site 64
Barcelona , 08035, Spain
Site 71
Sevilla , 41010, Spain
Site 75
Kharkiv , 61039, Ukraine
Site 73
Kiev , 03151, Ukraine
Site 74
Kyiv , 01023, Ukraine
Site 76
Kyiv , 02091, Ukraine
Site 72
Kyiv , 03110, Ukraine
Site 77
Odesa , 65025, Ukraine
Site 79
Vinnytsya , 21029, Ukraine
Site 78
Zaporizhzhia , 69600, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

286

Study ID:

NCT03552276

Recruitment Status:

Completed

Sponsor:


Sun Pharmaceutical Industries Limited

How clear is this clinincal trial information?

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