Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.
NCT ID: NCT03552276
Last Updated: 2024-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
281 participants
INTERVENTIONAL
2018-07-11
2023-09-18
Brief Summary
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Detailed Description
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The study has been open label post 1 year completion.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study was double blind until Databaselock of parent study happened to maintain blinding Subjects continue to assigned treatment from parent study up to week 52 in the Long term extension and there after all subjects began migrating to receive low dose injection Q12 weeks in an open-label fashion for up to an additional 4 years..
Study Groups
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SUNPG18_07 q4 weeks, high dose
Tildrakizumab 200 mg q4 Weeks
SUNPG18_07 I (Tildrakizumab 200 mg)
injection
SUNPG18_07 q12 weeks, high dose
Tildrakizumab 200 mg q12 Weeks
SUNPG18_07 I (Tildrakizumab 200 mg)
injection
SUNPG18_07 q12 weeks, low dose
Tildrakizumab 100 mg q12 Weeks
SUNPG18_07 II (Tildrakizumab 100 mg)
injection
SUNPG18_07 q4 Weeks, High Dose to SUNPG18_07 q12 Weeks, Low Dose
Tildrakizumab 200 mg q4 weeks switched to tildrakizumab 100 mg q12 weeks
SUNPG18_07 I (Tildrakizumab 200 mg)
injection
SUNPG18_07 II (Tildrakizumab 100 mg)
injection
SUNPG18_07 q12 Weeks, High Dose to SUNPG18_07 q12 Weeks, Low Dose
Tildrakizumab 200 mg q12 weeks switched to tildrakizumab 100 mg q12 weeks
SUNPG18_07 I (Tildrakizumab 200 mg)
injection
SUNPG18_07 II (Tildrakizumab 100 mg)
injection
Interventions
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SUNPG18_07 I (Tildrakizumab 200 mg)
injection
SUNPG18_07 II (Tildrakizumab 100 mg)
injection
Eligibility Criteria
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Inclusion Criteria
1. Subject has provided written informed consent for this long-term extension study.
3. No concomitant use of both leflunomide and methotrexate,
4. 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 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.
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 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.
7. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus during the parent study.
8. Subjects with a history of alcohol or drug abuse during the parent study.
9. 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.
10. Concomitant use of prohibited medications or use of commercially available or investigational biologic therapies (other than tildrakizumab) for PsO and/or PsA
11. Subjects who have been placed in an institution on official or judicial orders.
12. Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest may arise.
18 Years
ALL
No
Sponsors
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Sun Pharmaceutical Industries Limited
INDUSTRY
Responsible Party
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Locations
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Site 25
Glendale, Arizona, United States
Site 16
Phoenix, Arizona, United States
Site 14
Denver, Colorado, United States
Site 27
Wichita, Kansas, United States
Site 23
Lexington, Kentucky, United States
Site 20
Monroe, Louisiana, United States
Site 26
Lebanon, New Hampshire, United States
Site 24
Salisbury, North Carolina, United States
Site 19
Cincinnati, Ohio, United States
Site 17
Middleburg Heights, Ohio, United States
Site 18
Memphis, Tennessee, United States
Site 21
Seattle, Washington, United States
Site 22
Spokane, Washington, United States
Site 02
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Site 01
Mar del Plata, Buenos Aires, Argentina
Site 03
San Fernando, Buenos Aires, Argentina
Site 32
Budapest, , Hungary
Site 34
Budapest, , Hungary
Site 33
Kistarcsa, , Hungary
Site 09
Mexico City, Mexico City, Mexico
Site 05
Mexico City, Mexico City, Mexico
Site 06
Monterrey, Nuevo León, Mexico
Site 13
San Luis Potosí City, San Luis Potosí, Mexico
Site 04
San Luis Potosí City, San Luis Potosí, Mexico
Site 07
Culiacán, Sinaloa, Mexico
Site 12
Mérida, Yucatán, Mexico
Site 11
Chihuahua City, , Mexico
Site 08
Cuautitlán Izcalli, , Mexico
Site 10
Durango, , Mexico
Site 45
Krakow, Lesser Poland Voivodeship, Poland
Site 38
Bialystok, , Poland
Site 47
Bytom, , Poland
Site 36
Elblag, , Poland
Site 39
Katowice, , Poland
Site 40
Katowice, , Poland
Site 46
Krakow, , Poland
Site 43
Lodz, , Poland
Site 48
Nowa Sól, , Poland
Site 42
Poznan, , Poland
Site 53
Sochaczew, , Poland
Site 50
Warsaw, , Poland
Site 52
Warsaw, , Poland
Site 51
Wroclaw, , Poland
Site 61
Kemerovo, Kemerovo Oblast, Russia
Site 58
Novosibirsk, Novosibirsk Oblast, Russia
Site 54
Tomsk, Tomsk Oblast, Russia
Site 56
Izhevsk, , Russia
Site 60
Moscow, , Russia
Site 57
Saint Petersburg, , Russia
Site 62
Smolensk, , Russia
Site 55
Yaroslavl, , Russia
Site 59
Yaroslavl, , Russia
Site 67
Santiago de Compostela, La Coruna, Spain
Site 65
Málaga, Malaga, Spain
Site 68
Bilbao, Vizcaya, Spain
Site 66
Barcelona, , Spain
Site 64
Barcelona, , Spain
Site 71
Seville, , Spain
Site 75
Kharkiv, , Ukraine
Site 73
Kiev, , Ukraine
Site 74
Kyiv, , Ukraine
Site 76
Kyiv, , Ukraine
Site 72
Kyiv, , Ukraine
Site 77
Odesa, , Ukraine
Site 79
Vinnytsia, , Ukraine
Site 78
Zaporizhzhia, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLR_18_07
Identifier Type: -
Identifier Source: org_study_id
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