A Long Term Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis.
Study Purpose
A long term study to demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Inclusion Criteria:
1. Subject has provided written informed consent for this long-term extension study. 2. Subjects with psoriatic arthritis (PsA) and ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA) who met the inclusion criteria of the parent studies and completed the parent study treatment period (e.g., up to Week 48 for the parent Phase 2 studies, with the return for the end of treatment (EoT) assessment at Week 52). 3. PsA subjects who achieved a 20% reduction from Baseline in ACR20 response criteria at Week 52, and AS or nr-axSpA subjects who achieved ASAS40 response criteria at Week 52, AND the subject has received sufficient clinical benefit, in the opinion of the Investigator, to support continued treatment with tildrakizumab. These criteria using response criteria at Week 52 will apply to all subjects, including those subjects who enter the study from the wash-out phase of their parent study (after Week 52) due to the timing of study site activation of the long-term extension study. 4. No concomitant use of both leflunomide and methotrexate, No history of active tuberculosis (TB) or symptoms of TB.Exclusion Criteria:
1. New onset during the parent study of arthritic conditions other than the subject's original condition. 2. 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).
- - a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first IMP dose of the extension study, with the last dose having been received within 7 days of start of the extension study, - recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause this extension study to be detrimental to the subject.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03552276 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2/Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Sun Pharma Global FZE |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Hungary, Mexico, Poland, Russian Federation, Spain, Ukraine, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Psoriatic Arthritis, Ankylosing Spondylitis, Non-Radiographic Axial Spondyloarthritis |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Not yet recruiting
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Site 25
Glendale, Arizona, 85306
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Not yet recruiting
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Site 15
Mesa, Arizona, 85210
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Not yet recruiting
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Site 16
Phoenix, Arizona, 85032
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Not yet recruiting
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Site 28
Phoenix, Arizona, 85037
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Recruiting
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Site 14
Denver, Colorado, 80230
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Recruiting
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Site 27
Wichita, Kansas, 67207
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Recruiting
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Site 23
Lexington, Kentucky, 40504
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Not yet recruiting
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Site 20
Monroe, Louisiana, 71203
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Not yet recruiting
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Site 26
Lebanon, New Hampshire, 03756
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Not yet recruiting
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Site 24
Salisbury, North Carolina, 28144
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Recruiting
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Site 19
Cincinnati, Ohio, 45242
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Recruiting
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Site 17
Middleburg Heights, Ohio, 44130
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Recruiting
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Site 18
Memphis, Tennessee, 38119
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Not yet recruiting
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Site 21
Seattle, Washington, 98122
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Recruiting
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Site 22
Spokane, Washington, 99204
International Sites
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Not yet recruiting
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Site 02
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF
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Not yet recruiting
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Site 01
Mar Del Plata, Buenos Aires, 7600
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Not yet recruiting
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Site 03
San Fernando, Buenos Aires, 1646
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Not yet recruiting
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Site 30
Budapest, , 1023
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Site 32
Budapest, , 1036
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Site 34
Budapest, , 1062
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Site 33
Kistarcsa, , 2143
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Site 29
Nyíregyháza, , 4400
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Site 31
Szolnok, , 5000
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Not yet recruiting
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Site 09
Mexico, Distrito Federal, 06700
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Not yet recruiting
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Site 05
Mexico City, Mexico, City, 7760
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Not yet recruiting
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Site 06
Monterrey, Nuevo Leon, 64020
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Not yet recruiting
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Site 13
San Luis Potosí, San Luis Potosi, 78213
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Not yet recruiting
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Site 04
San Luis Potosí, San Luis Potosi, 78220
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Not yet recruiting
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Site 07
Culiacán, Sinaloa, 80000
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Site 12
Mérida, Yucatan, 97070
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Not yet recruiting
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Site 11
Chihuahua, , 31000
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Not yet recruiting
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Site 08
Cuautitlán Izcalli, , 54769
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Site 10
Durango, , 34080
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Not yet recruiting
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Site 45
Kraków, Malopolskie, 30-510
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Not yet recruiting
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Site 35
Elbląg, Warminsko-Mazurskie, 82-300
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Site 44
Białystok, , 15-099
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Not yet recruiting
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Site 38
Białystok, , 15-879
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Site 47
Bytom, , 41-902
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Site 36
Elbląg, , 82-300
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Site 39
Katowice, , 40-081
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Not yet recruiting
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Site 40
Katowice, , 40-282
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Not yet recruiting
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Site 46
Kraków, , 30-002
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Not yet recruiting
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Site 37
Lublin, , 20-607
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Not yet recruiting
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Site 48
Nowa Sól, , 67-100
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Not yet recruiting
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Site 42
Poznan, , 60-848
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Not yet recruiting
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Site 41
Poznań, , 61-397
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Not yet recruiting
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Site 53
Sochaczew, , 96-500
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Not yet recruiting
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Site 50
Warszawa, , 02-691
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Not yet recruiting
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Site 52
Warszawa, , 04-305
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Not yet recruiting
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Site 51
Wrocław, , 51-685
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Site 49
Wrocław, , 52-416
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Not yet recruiting
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Site 43
Łódź, , 90-265
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Site 61
Kemerovo, Kemerovo Region, 650066
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Not yet recruiting
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Site 58
Novosibirsk, Novosibirsk Oblast, 630099
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Not yet recruiting
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Site 63
Petrozavodsk, Republic Of Karelia, 185019
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Not yet recruiting
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Site 54
Tomsk, Tomsk Oblast, 634050
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Not yet recruiting
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Site 56
Izhevsk, , 426077
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Not yet recruiting
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Site 60
Moscow, , 115404
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Not yet recruiting
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Site 57
Saint-Petersburg, , 196084
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Not yet recruiting
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Site 62
Smolensk, , 214019
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Not yet recruiting
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Site 55
Yaroslavl, , 150003
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Site 59
Yaroslavl, , 150007
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Site 69
Sabadell, Barcelona, 08208
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Site 67
Santiago De Compostela, La Coruna, 15702
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Site 65
Málaga, Malaga, 29730
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Not yet recruiting
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Site 68
Bilbao, Vizcaya, 48013
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Not yet recruiting
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Site 66
Barcelona, , 08034
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Not yet recruiting
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Site 64
Barcelona, , 08035
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Not yet recruiting
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Site 70
Santiago De Compostela, , 15706
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Not yet recruiting
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Site 71
Sevilla, , 41010
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Not yet recruiting
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Site 75
Kharkiv, , 61039
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Not yet recruiting
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Site 73
Kiev, , 03151
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Site 74
Kyiv, , 01023
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Not yet recruiting
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Site 76
Kyiv, , 02091
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Not yet recruiting
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Site 72
Kyiv, , 03110
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Not yet recruiting
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Site 77
Odesa, , 65025
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Not yet recruiting
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Site 79
Vinnytsya, , 21029
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Not yet recruiting
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Site 78
Zaporizhzhia, , 69600