Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis
Study Purpose
An open label phase 3 study
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:
- - Subjects possess the ability to understand the requirements of the study.
- - Subject has provided written informed consent as evidenced by signature on an informed consent form approved by an institutional review board/EC.
- - Agree to abide by the study restrictions, scheduled treatment, laboratory assessments, other study procedures and return to the site for the required assessments.
- - Subject with PsA who had met all eligibility criteria for the parent study, had completed the parent study treatment period and has not developed any parent protocol criteria for premature discontinuation of treatment or withdrawal from the study.
Exclusion Criteria:
- - Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception.
- - Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 17 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.
Trial Details
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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. |
NCT04991116 |
|
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 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Sun Pharmaceutical Industries Limited |
|
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 | Australia, Czechia, Estonia, Germany, Japan, Korea, Republic of, Poland, Slovakia, Spain, Taiwan, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Psoriatic Arthritis |
Subjects from both INSPIRE 1 (TILD-19-07) and INSPIRE 2 (TILD-19-19) studies to roll over into this INSPIRE LTE study (TILD-21-01).
Arms
Experimental: TILD q12 weeks
Interventions
Drug: - TILD sub-cutaneous (SC) injection
1 mL injection of study medication
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
Recruiting
Address
Sunpharma site no 50
Dothan, Alabama, 36305
Status
Active, not recruiting
Address
Sunpharma site no 80
Gilbert, Arizona, 85297
Status
Recruiting
Address
Sunpharma site no 65
Mesa, Arizona, 85210
Status
Recruiting
Address
Sunpharma site no. 30
Covina, California, 91722
Status
Recruiting
Address
Sunpharma site no. 17
Fountain Valley, California, 92708
Status
Recruiting
Address
Sunpharma site no. 15
Thousand Oaks, California, 91320
Status
Recruiting
Address
Sunpharma site no. 21
Clearwater, Florida, 33765
Status
Recruiting
Address
Sunpharma site no. 02
Hialeah, Florida, 33016
Status
Recruiting
Address
Sunpharma site no 71
Kissimmee, Florida, 34744
Status
Recruiting
Address
Sunpharma site no. 05
New Port Richey, Florida, 34652
Status
Recruiting
Address
Sunpharma site no 32
Ocoee, Florida, 34751
Status
Recruiting
Address
SunPharma Site no 22
Tamarac, Florida, 33321
Status
Recruiting
Address
Sunpharma site no 52
Gainesville, Georgia, 30501
Status
Recruiting
Address
Sunpharma site no 51
Orland Park, Illinois, 60467
Status
Active, not recruiting
Address
Sunpharma site no 49
Schaumburg, Illinois, 60195
Status
Recruiting
Address
Sunpharma site no 47
Skokie, Illinois, 60076
Status
Recruiting
Address
Sunpharma site no. 20
Wichita, Kansas, 67207
Status
Recruiting
Address
Sunpharma site no. 14
Springfield, Missouri, 65807
Status
Recruiting
Address
Sunpharma site no 48
Kalispell, Montana, 59901
Status
Recruiting
Address
Sunpharma Site no 27
Lincoln, Nebraska, 68516
Status
Recruiting
Address
Sunpharma site no 33
Voorhees, New Jersey, 08043
Status
Recruiting
Address
Sunpharma site no 34
Charlotte, North Carolina, 28204
Status
Recruiting
Address
Sunpharma site no 53
Wilmington, North Carolina, 28401
Status
Recruiting
Address
Sunpharma site no 35
Minot, North Dakota, 58701
Status
Recruiting
Address
Sunpharma site no. 11
Middleburg Heights, Ohio, 44130
Status
Recruiting
Address
Sunpharma site no 31
Greenville, South Carolina, 29601
Status
Terminated
Address
Sunpharma site no. 08
Baytown, Texas, 77521
Status
Recruiting
Address
Sunpharma site no. 13
Baytown, Texas, 77521
Status
Recruiting
Address
Sunpharma Site no 28
Lubbock, Texas, 79410
Status
Not yet recruiting
Address
Sunpharma site no. 03
San Antonio, Texas, 78229
Status
Recruiting
Address
Sunpharma site no. 16
San Antonio, Texas, 78229
Status
Recruiting
Address
Sunpharma site no. 01
Tomball, Texas, 77375
Status
Recruiting
Address
Sunpharma site no 66
Spokane, Washington, 99204
International Sites
Status
Recruiting
Address
Sunpharma site no 59
Phillip, Australian Capital Territory, 2606
Status
Recruiting
Address
Sunpharma site no 58
Maroochydore, Queensland, 4558
Status
Recruiting
Address
Sunpharma site no. 24
Hobart, Tasmania, 7000
Status
Recruiting
Address
Sunpharma site no 36
Brno, , 638 00
Status
Recruiting
Address
Sunpharma site no 67
Praha 2, , 12800
Status
Recruiting
Address
Sunpharma site no 82
Zlin, , 760 01
Status
Recruiting
Address
Sunpharma site no 44
Tallinn, , 10117
Status
Recruiting
Address
Sunpharma site no 39
Tartu, , 50106
Status
Recruiting
Address
Sunpharma site no 40
Tartu, , 50708
Status
Recruiting
Address
Sunpharma site no 37
Berlin, , 12161
Status
Active, not recruiting
Address
Sunpharma site no 83
Herne, , 44649
Status
Recruiting
Address
Sunpharma site no 73
Shinjuku-ku, Tokyo, 160-0023
Status
Recruiting
Address
Sunpharma site no 45
Fukuoka, , 802-8561
Status
Recruiting
Address
Sunpharma site no 84
Itabashi-ku, , 173-8606
Status
Recruiting
Address
Sunpharma site no 46
Kumamoto-shi, , 860-8556
Status
Recruiting
Address
Sunpharma site no 72
Mitaka, , 181-8611
Status
Recruiting
Address
Sunpharma site no 79
Miyazaki, , 889-1692
Status
Active, not recruiting
Address
Sunpharma site no 78
Nagoya, , 467-8602
Status
Recruiting
Address
Sunpharma site no 64
Sendai-shi, , 545-8586
Status
Recruiting
Address
Sunpharma site no 63
Sendai-shi, , 980-8574
Status
Recruiting
Address
Sunpharma site no 87
Tsu, ,
Status
Recruiting
Address
Sunpharma site no 70
Seoul, , 3080
Status
Recruiting
Address
Sunpharma site no 43
Bialystok, , 15-351
Status
Recruiting
Address
Sunpharma site no 69
Bialystok, , 15-879
Status
Recruiting
Address
Sunpharma site no 56
Krakow, , 30-033
Status
Recruiting
Address
Sunpharma site no 81
Lublin, , 20-607
Status
Recruiting
Address
Sunpharma site no 55
Nadarzyn, , 05-830
Status
Active, not recruiting
Address
Sunpharma site no 85
Poznan, , 60-529
Status
Recruiting
Address
Sunpharma site no 68
Poznan, , 61-113
Status
Recruiting
Address
Sunpharma site no 60
Torun, , 87-100
Status
Recruiting
Address
Sunpharma site no 61
Warszawa, , 02-118
Status
Recruiting
Address
Sunpharma site no 74
Martin, , 036 01
Status
Recruiting
Address
Sunpharma site no 42
Nové Mesto Nad Váhom, , 915 01
Status
Active, not recruiting
Address
Sunpharma site no 41
Rimavska Sobota, , 97901
Status
Recruiting
Address
Sunpharma site no 38
Cordoba, , 14004
Status
Recruiting
Address
SunPharma Site No 23
Córdoba, , 14004
Status
Recruiting
Address
Sunpharma site no 57
La Coruña, , 15006
Status
Active, not recruiting
Address
Sunpharma site no 86
Malaga, , 29009
Status
Active, not recruiting
Address
Sunpharma site no 88
Santiago De Compostela, , 15706
Status
Recruiting
Address
Sunpharma site no 62
Sevilla, , 41013
Status
Recruiting
Address
Sunpharma site no 76
Kaohsiung, , 833
Status
Recruiting
Address
Sunpharma site no 54
Taichung, , 402
Status
Recruiting
Address
Sunpharma site no 75
Tainan, , 710
Status
Recruiting
Address
Sunpharma site no 77
Taipei, , 112
