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 Extension Study to Demonstrate Safety of Tildrakizumab in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.
1 other identifier
interventional
281
8 countries
66
Brief Summary
A long term study to demonstrate the safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2018
Longer than P75 for phase_2
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2018
CompletedFirst Posted
Study publicly available on registry
June 11, 2018
CompletedStudy Start
First participant enrolled
July 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2023
CompletedResults Posted
Study results publicly available
November 21, 2024
CompletedNovember 21, 2024
October 1, 2024
5.2 years
May 4, 2018
September 17, 2024
October 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events
Please refer to Adverse event section for more information
upto week 208
Study Arms (5)
SUNPG18_07 q4 weeks, high dose
EXPERIMENTALTildrakizumab 200 mg q4 Weeks
SUNPG18_07 q12 weeks, high dose
EXPERIMENTALTildrakizumab 200 mg q12 Weeks
SUNPG18_07 q12 weeks, low dose
EXPERIMENTALTildrakizumab 100 mg q12 Weeks
SUNPG18_07 q4 Weeks, High Dose to SUNPG18_07 q12 Weeks, Low Dose
EXPERIMENTALTildrakizumab 200 mg q4 weeks switched to tildrakizumab 100 mg q12 weeks
SUNPG18_07 q12 Weeks, High Dose to SUNPG18_07 q12 Weeks, Low Dose
EXPERIMENTALTildrakizumab 200 mg q12 weeks switched to tildrakizumab 100 mg q12 weeks
Interventions
injection
injection
Eligibility Criteria
You may qualify if:
- 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.
- No concomitant use of both leflunomide and methotrexate,
- No history of active tuberculosis (TB) or symptoms of TB.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
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, C1128AAF, 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 09
Mexico City, Mexico City, 06700, Mexico
Site 05
Mexico City, Mexico City, 7760, Mexico
Site 06
Monterrey, Nuevo León, 64020, Mexico
Site 13
San Luis Potosí City, San Luis Potosí, 78213, Mexico
Site 04
San Luis Potosí City, San Luis Potosí, 78220, Mexico
Site 07
Culiacán, Sinaloa, 80000, Mexico
Site 12
Mérida, Yucatán, 97070, Mexico
Site 11
Chihuahua City, 31000, Mexico
Site 08
Cuautitlán Izcalli, 54769, Mexico
Site 10
Durango, 34080, Mexico
Site 45
Krakow, Lesser Poland Voivodeship, 30-510, Poland
Site 38
Bialystok, 15-879, Poland
Site 47
Bytom, 41-902, Poland
Site 36
Elblag, 82-300, Poland
Site 39
Katowice, 40-081, Poland
Site 40
Katowice, 40-282, Poland
Site 46
Krakow, 30-002, Poland
Site 43
Lodz, 90-265, Poland
Site 48
Nowa Sól, 67-100, Poland
Site 42
Poznan, 60-848, Poland
Site 53
Sochaczew, 96-500, Poland
Site 50
Warsaw, 02-691, Poland
Site 52
Warsaw, 04-305, Poland
Site 51
Wroclaw, 51-685, Poland
Site 61
Kemerovo, Kemerovo Oblast, 650066, Russia
Site 58
Novosibirsk, Novosibirsk Oblast, 630099, Russia
Site 54
Tomsk, Tomsk Oblast, 634050, Russia
Site 56
Izhevsk, 426077, Russia
Site 60
Moscow, 115404, Russia
Site 57
Saint Petersburg, 196084, Russia
Site 62
Smolensk, 214019, Russia
Site 55
Yaroslavl, 150003, Russia
Site 59
Yaroslavl, 150007, Russia
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
Seville, 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
Vinnytsia, 21029, Ukraine
Site 78
Zaporizhzhia, 69600, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head-Regulatory Affairs
- Organization
- Sun Pharmaceutical Industries Limited
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- Subjects will be not be randomized and will enter the long-term extension study with one fixed dose regimen of tildrakizumab, low dose regimen at Week 52 of the parent study. 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..
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2018
First Posted
June 11, 2018
Study Start
July 11, 2018
Primary Completion
September 18, 2023
Study Completion
September 18, 2023
Last Updated
November 21, 2024
Results First Posted
November 21, 2024
Record last verified: 2024-10