Clinical trial NCT03552276: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Psoriatic Arthritis
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2018-06-11
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

Subjects may be included in the study if they meet all of the following criteria:

1. Subject has provided written informed consent for this long-term extension study.
2. 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).
3. No concomitant use of both leflunomide and methotrexate,
4. 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:

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.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: upto week 208
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Site 25
state: Arizona
city: Phoenix
country: United States
facility: Site 16
state: Arizona
city: Denver
country: United States
facility: Site 14
state: Colorado
city: Wichita
country: United States
facility: Site 27
state: Kansas
city: Lexington
country: United States
facility: Site 23
state: Kentucky
city: Monroe
country: United States
facility: Site 20
state: Louisiana
city: Lebanon
country: United States
facility: Site 26
state: New Hampshire
city: Salisbury
country: United States
facility: Site 24
state: North Carolina
city: Cincinnati
country: United States
facility: Site 19
state: Ohio
city: Middleburg Heights
country: United States
facility: Site 17
state: Ohio
city: Memphis
country: United States
facility: Site 18
state: Tennessee
city: Seattle
country: United States
facility: Site 21
state: Washington
city: Spokane
country: United States
facility: Site 22
state: Washington
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Site 02
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Site 01
state: Buenos Aires
city: San Fernando
country: Argentina
facility: Site 03
state: Buenos Aires
city: Budapest
country: Hungary
facility: Site 32
city: Budapest
country: Hungary
facility: Site 34
city: Kistarcsa
country: Hungary
facility: Site 33
city: Mexico
country: Mexico
facility: Site 09
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Site 05
state: Mexico, City
city: Monterrey
country: Mexico
facility: Site 06
state: Nuevo Leon
city: San Luis Potosí
country: Mexico
facility: Site 13
state: San Luis Potosi
city: San Luis Potosí
country: Mexico
facility: Site 04
state: San Luis Potosi
city: Culiacán
country: Mexico
facility: Site 07
state: Sinaloa
city: Mérida
country: Mexico
facility: Site 12
state: Yucatan
city: Chihuahua
country: Mexico
facility: Site 11
city: Cuautitlán Izcalli
country: Mexico
facility: Site 08
city: Durango
country: Mexico
facility: Site 10
city: Kraków
country: Poland
facility: Site 45
state: Malopolskie
city: Białystok
country: Poland
facility: Site 38
city: Bytom
country: Poland
facility: Site 47
city: Elbląg
country: Poland
facility: Site 36
city: Katowice
country: Poland
facility: Site 39
city: Katowice
country: Poland
facility: Site 40
city: Kraków
country: Poland
facility: Site 46
city: Nowa Sól
country: Poland
facility: Site 48
city: Poznan
country: Poland
facility: Site 42
city: Sochaczew
country: Poland
facility: Site 53
city: Warszawa
country: Poland
facility: Site 50
city: Warszawa
country: Poland
facility: Site 52
city: Wrocław
country: Poland
facility: Site 51
city: Łódź
country: Poland
facility: Site 43
city: Kemerovo
country: Russian Federation
facility: Site 61
state: Kemerovo Region
city: Novosibirsk
country: Russian Federation
facility: Site 58
state: Novosibirsk Oblast
city: Tomsk
country: Russian Federation
facility: Site 54
state: Tomsk Oblast
city: Izhevsk
country: Russian Federation
facility: Site 56
city: Moscow
country: Russian Federation
facility: Site 60
city: Saint-Petersburg
country: Russian Federation
facility: Site 57
city: Smolensk
country: Russian Federation
facility: Site 62
city: Yaroslavl
country: Russian Federation
facility: Site 55
city: Yaroslavl
country: Russian Federation
facility: Site 59
city: Santiago De Compostela
country: Spain
facility: Site 67
state: La Coruna
city: Málaga
country: Spain
facility: Site 65
state: Malaga
city: Bilbao
country: Spain
facility: Site 68
state: Vizcaya
city: Barcelona
country: Spain
facility: Site 66
city: Barcelona
country: Spain
facility: Site 64
city: Sevilla
country: Spain
facility: Site 71
city: Kharkiv
country: Ukraine
facility: Site 75
city: Kiev
country: Ukraine
facility: Site 73
city: Kyiv
country: Ukraine
facility: Site 74
city: Kyiv
country: Ukraine
facility: Site 76
city: Kyiv
country: Ukraine
facility: Site 72
city: Odesa
country: Ukraine
facility: Site 77
city: Vinnytsya
country: Ukraine
facility: Site 79
city: Zaporizhzhia
country: Ukraine
facility: Site 78
Study officials:
References: