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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

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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).
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 practised upon entering the study and through 16 weeks after the last dose of IMP. If a subject discontinues prematurely, the contraceptive method must be practised for 16 weeks following final administration of IMP. 3. 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. 4. Subject has previously been enrolled in this long-term extension study. 5. 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. 6. Subject has an active infection or history of infections as follows:
  • - 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.
7. Major chronic inflammatory or connective tissue disease other than PsA or AS/nr axSpA (e.g., rheumatoid arthritis, systemic lupus erythematosus, Lyme disease, and gout). 8. Known diagnosis of fibromyalgia, regional pain syndromes or active uveitis/symptomatic inflammatory bowel disease requiring therapy (AS/nr-axSpA subjects), 9. Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anaemia) that, in the opinion of the Investigator, could cause continued treatment to be detrimental to the subject. 10. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus during the parent study. 11. Subject had a myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose for this extension study. 12. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma. 13. Subject has a history of malignancy EXCEPT treated and considered cured cutaneous basal or squamous cell carcinoma, in situ cervical carcinoma, OR in situ breast ductal carcinoma. 14. Subjects with a history of alcohol or drug abuse during the parent study. 15. Significant risk of suicidality at the Baseline assessment of this extension study based on the Investigator's judgment or, if appropriate, as indicated by a response of "yes" since the last visit to question 4 or 5 in the suicidal section, or any response in the behavioral section of the Columbia-Suicide Severity Rating Scale (C SSRS). 16. 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. 17. Concomitant use of prohibited medications or use of commercially available or investigational biologic therapies (other than tildrakizumab) for psoriasis, PsA, and/or AS/nr axSpA. General: 18. Subjects who have been placed in an institution on official or judicial orders. 19. Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest may arise.

Trial Details

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.

Trial ID:
NCT03552276

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
Phase 2/Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Sun Pharma Global FZE

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
N/A
Principal Investigator Affiliation N/A

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Argentina, Hungary, Mexico, Poland, Russian Federation, Spain, Ukraine, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
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.

Site 25, Glendale, Arizona

Status

Not yet recruiting

Address

Site 25

Glendale, Arizona, 85306

Site Contact

Eric A Peters, Dr

[email protected]

480-443-8400

Site 15, Mesa, Arizona

Status

Not yet recruiting

Address

Site 15

Mesa, Arizona, 85210

Site Contact

Paul H Caldron, Dr

[email protected]

480-626-6653

Site 16, Phoenix, Arizona

Status

Not yet recruiting

Address

Site 16

Phoenix, Arizona, 85032

Site Contact

Saima Chohan, Dr

[email protected]

614-293-0080

Site 28, Phoenix, Arizona

Status

Not yet recruiting

Address

Site 28

Phoenix, Arizona, 85037

Site Contact

John R Tesser, Dr

[email protected]

91226645 5645

Site 14, Denver, Colorado

Status

Recruiting

Address

Site 14

Denver, Colorado, 80230

Site Contact

Christopher Antolini, Dr

[email protected]

303-394-2828

Site 81, Palm Harbor, Florida

Status

Terminated

Address

Site 81

Palm Harbor, Florida, 34684

Site Contact

91226645 5645

Site 27, Wichita, Kansas

Status

Recruiting

Address

Site 27

Wichita, Kansas, 67207

Site Contact

Shadi Shahouri, Dr

[email protected]

316-689-6665

Site 23, Lexington, Kentucky

Status

Recruiting

Address

Site 23

Lexington, Kentucky, 40504

Site Contact

Jeffrey S Neal

[email protected]

859-351-5175

Site 20, Monroe, Louisiana

Status

Not yet recruiting

Address

Site 20

Monroe, Louisiana, 71203

Site Contact

Jyothi Mallepalli, MD

[email protected]

318-812-1250

Site 26, Lebanon, New Hampshire

Status

Not yet recruiting

Address

Site 26

Lebanon, New Hampshire, 03756

Site Contact

William F Rigby, Dr

[email protected]

603-650-4717

Site 24, Salisbury, North Carolina

Status

Not yet recruiting

Address

Site 24

Salisbury, North Carolina, 28144

Site Contact

Rakesh C Patel, Dr

[email protected]

704-647-9913

Site 19, Cincinnati, Ohio

Status

Recruiting

Address

Site 19

Cincinnati, Ohio, 45242

Site Contact

Michael E Luggen, MD

[email protected]

513-559-2370

Site 17, Middleburg Heights, Ohio

Status

Recruiting

Address

Site 17

Middleburg Heights, Ohio, 44130

Site Contact

Isam A Diab, Dr

[email protected]

440-826-0742

Site 18, Memphis, Tennessee

Status

Recruiting

Address

Site 18

Memphis, Tennessee, 38119

Site Contact

Ramesh C Gupta, Dr

[email protected]

901-681-9670

Site 21, Seattle, Washington

Status

Not yet recruiting

Address

Site 21

Seattle, Washington, 98122

Site Contact

Philip J Mease, Dr

[email protected]

206-386-2001

Site 22, Spokane, Washington

Status

Recruiting

Address

Site 22

Spokane, Washington, 99204

Site Contact

Eric C Mueller, Dr

[email protected]

509-838-6500

International Sites

Site 02, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Status

Not yet recruiting

Address

Site 02

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF

Site Contact

Julio Hofman, Dr

[email protected]

+ 54 11 4514 3400 int 226

Site 01, Mar Del Plata, Buenos Aires, Argentina

Status

Not yet recruiting

Address

Site 01

Mar Del Plata, Buenos Aires, 7600

Site Contact

Juan Pablo Gulin, Dr

[email protected]

54 92234561326

Site 03, San Fernando, Buenos Aires, Argentina

Status

Not yet recruiting

Address

Site 03

San Fernando, Buenos Aires, 1646

Site Contact

Maria Alicia Lazaro, Dr

[email protected]

54 91164620494

Site 80, Córdoba, Cordoba, Argentina

Status

Terminated

Address

Site 80

Córdoba, Cordoba, X5000JHQ

Site Contact

91226645 5645

Site 30, Budapest, Hungary

Status

Not yet recruiting

Address

Site 30

Budapest, , 1023

Site Contact

Laszlo Hodinka, Dr

[email protected]

36 14388328

Site 32, Budapest, Hungary

Status

Not yet recruiting

Address

Site 32

Budapest, , 1036

Site Contact

Istvan Szombati, Dr

[email protected]

36 12448249

Site 34, Budapest, Hungary

Status

Not yet recruiting

Address

Site 34

Budapest, , 1062

Site Contact

Ilona Ujfalussy, Dr Med

[email protected]

36 314651800

Site 33, Kistarcsa, Hungary

Status

Not yet recruiting

Address

Site 33

Kistarcsa, , 2143

Site Contact

Edit Agnes Toth, Dr

[email protected]

36 28507716

Site 29, Nyíregyháza, Hungary

Status

Not yet recruiting

Address

Site 29

Nyíregyháza, , 4400

Site Contact

Attila Bartha, Dr

[email protected]

36 42 465 666

Site 31, Szolnok, Hungary

Status

Not yet recruiting

Address

Site 31

Szolnok, , 5000

Site Contact

Attila Kovacs, Dr

[email protected]

+36 56524626

Site 09, Mexico, Distrito Federal, Mexico

Status

Not yet recruiting

Address

Site 09

Mexico, Distrito Federal, 06700

Site Contact

Francisco Guillermo Medina Rodriguez, Prof Dr

[email protected]

52 55 55140804

Site 05, Mexico City, Mexico, City, Mexico

Status

Not yet recruiting

Address

Site 05

Mexico City, Mexico, City, 7760

Site Contact

Sandra Miriam Carrillo Vazquez, Dr Med

[email protected]

52 5557524673

Site 06, Monterrey, Nuevo Leon, Mexico

Status

Not yet recruiting

Address

Site 06

Monterrey, Nuevo Leon, 64020

Site Contact

Mario A Garza-Elizondo, Dr

[email protected]

528180485210 x3

Site 13, San Luis Potosí, San Luis Potosi, Mexico

Status

Not yet recruiting

Address

Site 13

San Luis Potosí, San Luis Potosi, 78213

Site Contact

Juan C Rizo Rodriguez, Dr

[email protected]

52 4448084352

Site 04, San Luis Potosí, San Luis Potosi, Mexico

Status

Not yet recruiting

Address

Site 04

San Luis Potosí, San Luis Potosi, 78220

Site Contact

Carlos Abud Mendoza, Dr

[email protected]

52 4448342781

Site 07, Culiacán, Sinaloa, Mexico

Status

Not yet recruiting

Address

Site 07

Culiacán, Sinaloa, 80000

Site Contact

Marco A Maradiaga Cecena, Dr Med

[email protected]

52 6677136751

Site 12, Mérida, Yucatan, Mexico

Status

Not yet recruiting

Address

Site 12

Mérida, Yucatan, 97070

Site Contact

Blanca Irma Pinzon De la O, Dr

[email protected]

52 9999201227

Site 11, Chihuahua, Mexico

Status

Not yet recruiting

Address

Site 11

Chihuahua, , 31000

Site Contact

Cesar F Pacheco-Tena, Dr

[email protected]

52 16141961278

Site 08, Cuautitlán Izcalli, Mexico

Status

Not yet recruiting

Address

Site 08

Cuautitlán Izcalli, , 54769

Site Contact

Juan Manuel Martinez Noriega, Dr

[email protected]

52 5558713935

Site 10, Durango, Mexico

Status

Not yet recruiting

Address

Site 10

Durango, , 34080

Site Contact

Enrique Ortiz Jimenez, Dr

[email protected]

52 6188173940

Site 45, Kraków, Malopolskie, Poland

Status

Not yet recruiting

Address

Site 45

Kraków, Malopolskie, 30-510

Site Contact

Mariusz Korkosz, Dr

[email protected]

48122954139

Site 35, Elbląg, Warminsko-Mazurskie, Poland

Status

Not yet recruiting

Address

Site 35

Elbląg, Warminsko-Mazurskie, 82-300

Site Contact

Barbara Bazela, Dr

[email protected]

48608202021

Site 44, Białystok, Poland

Status

Not yet recruiting

Address

Site 44

Białystok, , 15-099

Site Contact

Piotr A Klimiuk, Prof

[email protected]

48604442168

Site 38, Białystok, Poland

Status

Not yet recruiting

Address

Site 38

Białystok, , 15-879

Site Contact

Stefan Daniluk, Dr

[email protected]

48857446333

Site 47, Bytom, Poland

Status

Not yet recruiting

Address

Site 47

Bytom, , 41-902

Site Contact

Hanna Mastalerz, Dr

[email protected]

48508270636

Site 36, Elbląg, Poland

Status

Not yet recruiting

Address

Site 36

Elbląg, , 82-300

Site Contact

Jan Brzezicki, Dr

[email protected]

48552211440

Site 39, Katowice, Poland

Status

Not yet recruiting

Address

Site 39

Katowice, , 40-081

Site Contact

Tomasz Dziewit, Dr

[email protected]

48 511926507

Site 40, Katowice, Poland

Status

Not yet recruiting

Address

Site 40

Katowice, , 40-282

Site Contact

Joanna Gozdzik, Dr

[email protected]

91226645 5645

Site 46, Kraków, Poland

Status

Not yet recruiting

Address

Site 46

Kraków, , 30-002

Site Contact

Piotr Krawiec, Dr

[email protected]

603185855

Site 37, Lublin, Poland

Status

Not yet recruiting

Address

Site 37

Lublin, , 20-607

Site Contact

Dariusz Chudzik, Dr

[email protected]

48 814404304

Site 48, Nowa Sól, Poland

Status

Not yet recruiting

Address

Site 48

Nowa Sól, , 67-100

Site Contact

Malgorzata Miakisz, Dr

[email protected]

48881691717

Site 42, Poznan, Poland

Status

Not yet recruiting

Address

Site 42

Poznan, , 60-848

Site Contact

Maria Jaraczewska-Baumann, Dr

[email protected]

48 616579624

Site 41, Poznań, Poland

Status

Not yet recruiting

Address

Site 41

Poznań, , 61-397

Site Contact

Pawel Hrycaj, Prof Dr

[email protected]

48618750888

Site 53, Sochaczew, Poland

Status

Not yet recruiting

Address

Site 53

Sochaczew, , 96-500

Site Contact

Monika Wronisz, Dr

[email protected]

48697777777

Site 50, Warszawa, Poland

Status

Not yet recruiting

Address

Site 50

Warszawa, , 02-691

Site Contact

Paula M Sliwinska-Stanczyk, Dr

[email protected]

48784969702

Site 52, Warszawa, Poland

Status

Not yet recruiting

Address

Site 52

Warszawa, , 04-305

Site Contact

Jakub Trefler, Dr Med

[email protected]

48888171425

Site 51, Wrocław, Poland

Status

Not yet recruiting

Address

Site 51

Wrocław, , 51-685

Site Contact

Jerzy Swierkot, Asst Prof

[email protected]

48 713400021

Site 49, Wrocław, Poland

Status

Not yet recruiting

Address

Site 49

Wrocław, , 52-416

Site Contact

Maria Misterska-Skora, Dr Med

[email protected]

48501104244

Site 43, Łódź, Poland

Status

Not yet recruiting

Address

Site 43

Łódź, , 90-265

Site Contact

Andrzej Kaszuba, Prof

[email protected]

48426326562

Site 61, Kemerovo, Kemerovo Region, Russian Federation

Status

Not yet recruiting

Address

Site 61

Kemerovo, Kemerovo Region, 650066

Site Contact

Svetlana A Smakotina, Dr

[email protected]

7 3842396458

Site 58, Novosibirsk, Novosibirsk Oblast, Russian Federation

Status

Not yet recruiting

Address

Site 58

Novosibirsk, Novosibirsk Oblast, 630099

Site Contact

Tatyana V Mikhaylova, Dr

[email protected]

79139066693

Site 63, Petrozavodsk, Republic Of Karelia, Russian Federation

Status

Not yet recruiting

Address

Site 63

Petrozavodsk, Republic Of Karelia, 185019

Site Contact

Natalia N Vezikova, Dr Med

[email protected]

79114014021

Site 54, Tomsk, Tomsk Oblast, Russian Federation

Status

Not yet recruiting

Address

Site 54

Tomsk, Tomsk Oblast, 634050

Site Contact

Larisa V Eliseeva, Dr

[email protected]

7 3822899997

Site 56, Izhevsk, Russian Federation

Status

Not yet recruiting

Address

Site 56

Izhevsk, , 426077

Site Contact

Larisa Ivanova, Dr

[email protected]

91226645 5645

Site 82, Kursk, Russian Federation

Status

Terminated

Address

Site 82

Kursk, , 305007

Site Contact

91226645 5645

Site 60, Moscow, Russian Federation

Status

Not yet recruiting

Address

Site 60

Moscow, , 115404

Site Contact

Mikhail Y Sandin, Dr

[email protected]

74956550195

Site 57, Saint-Petersburg, Russian Federation

Status

Not yet recruiting

Address

Site 57

Saint-Petersburg, , 196084

Site Contact

Tatyana G Makulova, Dr

[email protected]

78123692486

Site 62, Smolensk, Russian Federation

Status

Not yet recruiting

Address

Site 62

Smolensk, , 214019

Site Contact

Olga U Stetsiouk, Dr

[email protected]

79107850052

Site 55, Yaroslavl, Russian Federation

Status

Not yet recruiting

Address

Site 55

Yaroslavl, , 150003

Site Contact

Olga B Ershova, Prof

[email protected]

74852738850

Site 59, Yaroslavl, Russian Federation

Status

Not yet recruiting

Address

Site 59

Yaroslavl, , 150007

Site Contact

Sergey Noskov, Prof

[email protected]

74852242332

Site 69, Sabadell, Barcelona, Spain

Status

Not yet recruiting

Address

Site 69

Sabadell, Barcelona, 08208

Site Contact

Jordi Gratacos Masmitja, Prof

[email protected]

34 937231010 24061

Site 67, Santiago De Compostela, La Coruna, Spain

Status

Not yet recruiting

Address

Site 67

Santiago De Compostela, La Coruna, 15702

Site Contact

Juan Garcia Meijide, Dr

[email protected]

34 658386164

Site 65, Málaga, Malaga, Spain

Status

Not yet recruiting

Address

Site 65

Málaga, Malaga, 29730

Site Contact

Antonio Fernandez-Nebro, Dr Med

[email protected]

34951290206

Site 68, Bilbao, Vizcaya, Spain

Status

Not yet recruiting

Address

Site 68

Bilbao, Vizcaya, 48013

Site Contact

Maria Luz Garcia Vivar, Dr Med

[email protected]

34 944006068

Site 66, Barcelona, Spain

Status

Not yet recruiting

Address

Site 66

Barcelona, , 08034

Site Contact

Ferran J Garcia Fructuoso, Dr

[email protected]

34935522700

Site 64, Barcelona, Spain

Status

Not yet recruiting

Address

Site 64

Barcelona, , 08035

Site Contact

Juan Jose de Agustin de Oro, Dr Med

[email protected]

0034 034894298

Site 70, Santiago De Compostela, Spain

Status

Not yet recruiting

Address

Site 70

Santiago De Compostela, , 15706

Site Contact

Antonio Mera Varela, Dr

[email protected]

34 981951036

Site 71, Sevilla, Spain

Status

Not yet recruiting

Address

Site 71

Sevilla, , 41010

Site Contact

Federico Navarro Sarabia, Dr

[email protected]

34 615535323

Site 75, Kharkiv, Ukraine

Status

Not yet recruiting

Address

Site 75

Kharkiv, , 61039

Site Contact

Yuriy Gasanov

[email protected]

91226645 5645

Site 73, Kiev, Ukraine

Status

Not yet recruiting

Address

Site 73

Kiev, , 03151

Site Contact

Oleg Bortkevych, Dr

[email protected]

38 0672098205

Site 74, Kyiv, Ukraine

Status

Not yet recruiting

Address

Site 74

Kyiv, , 01023

Site Contact

Dmytro Fedkov, Dr

[email protected]

380 664667147

Site 76, Kyiv, Ukraine

Status

Not yet recruiting

Address

Site 76

Kyiv, , 02091

Site Contact

Victoria V Kachur, Dr

[email protected]

91226645 5645

Site 72, Kyiv, Ukraine

Status

Not yet recruiting

Address

Site 72

Kyiv, , 03110

Site Contact

Olga Barna, Prof

[email protected]

38 0504479037

Site 77, Odesa, Ukraine

Status

Not yet recruiting

Address

Site 77

Odesa, , 65025

Site Contact

Olena M Levchenko, Prof

[email protected]

380 503907846

Site 83, Vinnytsya, Ukraine

Status

Terminated

Address

Site 83

Vinnytsya, , 21018

Site Contact

91226645 5645

Site 79, Vinnytsya, Ukraine

Status

Not yet recruiting

Address

Site 79

Vinnytsya, , 21029

Site Contact

Sergiy Shevchuk, Dr

[email protected]

380 662866550

Site 78, Zaporizhzhia, Ukraine

Status

Not yet recruiting

Address

Site 78

Zaporizhzhia, , 69600

Site Contact

Dmitro Rekalov, Asst Prof

[email protected]

380504216492

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