Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.
Primary Purpose
Psoriatic Arthritis
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SUNPG18_07 I
SUNPG18_07 II
SUNPG18_07 III
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis
Eligibility Criteria
Inclusion Criteria:
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.
- Subjects with PsA who met the inclusion criteria of the parent study and completed the parent study treatment period (e.g., up to Week 48 for the parent Phase 2 study, with return for the EoT assessment at Week 52).
- No concomitant use of both leflunomide and methotrexate,
- No history of active tuberculosis (TB) or symptoms of TB.
Exclusion Criteria:
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.
Sites / Locations
- Site 25
- Site 16
- Site 14
- Site 27
- Site 23
- Site 20
- Site 26
- Site 24
- Site 19
- Site 17
- Site 18
- Site 21
- Site 22
- Site 02
- Site 01
- Site 03
- Site 32
- Site 34
- Site 33
- Site 31
- Site 09
- Site 05
- Site 06
- Site 13
- Site 04
- Site 07
- Site 12
- Site 11
- Site 08
- Site 10
- Site 45
- Site 38
- Site 47
- Site 36
- Site 39
- Site 40
- Site 46
- Site 48
- Site 42
- Site 53
- Site 50
- Site 52
- Site 51
- Site 43
- Site 61
- Site 58
- Site 54
- Site 56
- Site 60
- Site 57
- Site 62
- Site 55
- Site 59
- Site 67
- Site 65
- Site 68
- Site 66
- Site 64
- Site 71
- Site 75
- Site 73
- Site 74
- Site 76
- Site 72
- Site 77
- Site 79
- Site 78
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
SUNPG18_07 q4 weeks, high dose
SUNPG18_07 q12 weeks, high dose
SUNPG18_07 q12 weeks, low dose
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants with adverse events and its relationship to investigational medicinal product will be assessed by the Investigator (Global Introspection assessment)
Secondary Outcome Measures
Full Information
NCT ID
NCT03552276
First Posted
May 4, 2018
Last Updated
October 10, 2023
Sponsor
Sun Pharmaceutical Industries Limited
1. Study Identification
Unique Protocol Identification Number
NCT03552276
Brief Title
Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.
Official Title
A Long-Term Extension Study to Demonstrate Safety of Tildrakizumab in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 11, 2018 (Actual)
Primary Completion Date
September 18, 2023 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A long term study to demonstrate the safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab
Detailed Description
Subjects have rolled over from parent study, i.e., CLR_16_23, into the long-term extension study CLR_18_07.
The study has been open label post 1 year completion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Masking Description
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 continued to be double blind until wk 52 of the parent study i.e. CLR_16_23 and there after open label.
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..
Allocation
Non-Randomized
Enrollment
286 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SUNPG18_07 q4 weeks, high dose
Arm Type
Experimental
Arm Title
SUNPG18_07 q12 weeks, high dose
Arm Type
Experimental
Arm Title
SUNPG18_07 q12 weeks, low dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SUNPG18_07 I
Intervention Description
injection
Intervention Type
Drug
Intervention Name(s)
SUNPG18_07 II
Intervention Description
injection
Intervention Type
Drug
Intervention Name(s)
SUNPG18_07 III
Intervention Description
injection
Primary Outcome Measure Information:
Title
Number of Participants with adverse events and its relationship to investigational medicinal product will be assessed by the Investigator (Global Introspection assessment)
Time Frame
upto week 208
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Subjects with PsA who met the inclusion criteria of the parent study and completed the parent study treatment period (e.g., up to Week 48 for the parent Phase 2 study, with return for the EoT assessment at Week 52).
No concomitant use of both leflunomide and methotrexate,
No history of active tuberculosis (TB) or symptoms of TB.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Site 25
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Site 16
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Site 14
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Site 27
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Site 23
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Site 20
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Site 26
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Site 24
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Site 19
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Site 17
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Site 18
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Site 21
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Site 22
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Site 02
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1128AAF
Country
Argentina
Facility Name
Site 01
City
Mar Del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Site 03
City
San Fernando
State/Province
Buenos Aires
ZIP/Postal Code
1646
Country
Argentina
Facility Name
Site 32
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Site 34
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Site 33
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Site 31
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Site 09
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Site 05
City
Mexico City
State/Province
Mexico, City
ZIP/Postal Code
7760
Country
Mexico
Facility Name
Site 06
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64020
Country
Mexico
Facility Name
Site 13
City
San Luis Potosí
State/Province
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Site 04
City
San Luis Potosí
State/Province
San Luis Potosi
ZIP/Postal Code
78220
Country
Mexico
Facility Name
Site 07
City
Culiacán
State/Province
Sinaloa
ZIP/Postal Code
80000
Country
Mexico
Facility Name
Site 12
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Site 11
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Site 08
City
Cuautitlán Izcalli
ZIP/Postal Code
54769
Country
Mexico
Facility Name
Site 10
City
Durango
ZIP/Postal Code
34080
Country
Mexico
Facility Name
Site 45
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Site 38
City
Białystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Site 47
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Site 36
City
Elbląg
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Site 39
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Facility Name
Site 40
City
Katowice
ZIP/Postal Code
40-282
Country
Poland
Facility Name
Site 46
City
Kraków
ZIP/Postal Code
30-002
Country
Poland
Facility Name
Site 48
City
Nowa Sól
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Site 42
City
Poznan
ZIP/Postal Code
60-848
Country
Poland
Facility Name
Site 53
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Facility Name
Site 50
City
Warszawa
ZIP/Postal Code
02-691
Country
Poland
Facility Name
Site 52
City
Warszawa
ZIP/Postal Code
04-305
Country
Poland
Facility Name
Site 51
City
Wrocław
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Site 43
City
Łódź
ZIP/Postal Code
90-265
Country
Poland
Facility Name
Site 61
City
Kemerovo
State/Province
Kemerovo Region
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Site 58
City
Novosibirsk
State/Province
Novosibirsk Oblast
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Site 54
City
Tomsk
State/Province
Tomsk Oblast
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Site 56
City
Izhevsk
ZIP/Postal Code
426077
Country
Russian Federation
Facility Name
Site 60
City
Moscow
ZIP/Postal Code
115404
Country
Russian Federation
Facility Name
Site 57
City
Saint-Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
Site 62
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Site 55
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Site 59
City
Yaroslavl
ZIP/Postal Code
150007
Country
Russian Federation
Facility Name
Site 67
City
Santiago De Compostela
State/Province
La Coruna
ZIP/Postal Code
15702
Country
Spain
Facility Name
Site 65
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29730
Country
Spain
Facility Name
Site 68
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Site 66
City
Barcelona
ZIP/Postal Code
08034
Country
Spain
Facility Name
Site 64
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Site 71
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Site 75
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Site 73
City
Kiev
ZIP/Postal Code
03151
Country
Ukraine
Facility Name
Site 74
City
Kyiv
ZIP/Postal Code
01023
Country
Ukraine
Facility Name
Site 76
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Site 72
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Site 77
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Site 79
City
Vinnytsya
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Site 78
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
12. IPD Sharing Statement
Learn more about this trial
Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.
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