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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03552276
Other study ID # CLR_18_07
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date July 11, 2018
Est. completion date January 22, 2024

Study information

Verified date June 2023
Source Sun Pharmaceutical Industries Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A long term study to demonstrate the safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab


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.


Recruitment information / eligibility

Status Completed
Enrollment 286
Est. completion date January 22, 2024
Est. primary completion date September 18, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SUNPG18_07 I
injection
SUNPG18_07 II
injection
SUNPG18_07 III
injection

Locations

Country Name City State
Argentina Site 02 Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina Site 01 Mar Del Plata Buenos Aires
Argentina Site 03 San Fernando Buenos Aires
Hungary Site 32 Budapest
Hungary Site 34 Budapest
Hungary Site 33 Kistarcsa
Hungary Site 31 Szolnok
Mexico Site 11 Chihuahua
Mexico Site 08 Cuautitlán Izcalli
Mexico Site 07 Culiacán Sinaloa
Mexico Site 10 Durango
Mexico Site 12 Mérida Yucatan
Mexico Site 09 Mexico Distrito Federal
Mexico Site 05 Mexico City Mexico, City
Mexico Site 06 Monterrey Nuevo Leon
Mexico Site 04 San Luis Potosí San Luis Potosi
Mexico Site 13 San Luis Potosí San Luis Potosi
Poland Site 38 Bialystok
Poland Site 47 Bytom
Poland Site 36 Elblag
Poland Site 39 Katowice
Poland Site 40 Katowice
Poland Site 45 Kraków Malopolskie
Poland Site 46 Kraków
Poland Site 43 Lódz
Poland Site 48 Nowa Sól
Poland Site 42 Poznan
Poland Site 53 Sochaczew
Poland Site 50 Warszawa
Poland Site 52 Warszawa
Poland Site 51 Wroclaw
Russian Federation Site 56 Izhevsk
Russian Federation Site 61 Kemerovo Kemerovo Region
Russian Federation Site 60 Moscow
Russian Federation Site 58 Novosibirsk Novosibirsk Oblast
Russian Federation Site 57 Saint-Petersburg
Russian Federation Site 62 Smolensk
Russian Federation Site 54 Tomsk Tomsk Oblast
Russian Federation Site 55 Yaroslavl
Russian Federation Site 59 Yaroslavl
Spain Site 64 Barcelona
Spain Site 66 Barcelona
Spain Site 68 Bilbao Vizcaya
Spain Site 65 Málaga Malaga
Spain Site 67 Santiago De Compostela La Coruna
Spain Site 71 Sevilla
Ukraine Site 75 Kharkiv
Ukraine Site 73 Kiev
Ukraine Site 72 Kyiv
Ukraine Site 74 Kyiv
Ukraine Site 76 Kyiv
Ukraine Site 77 Odesa
Ukraine Site 79 Vinnytsya
Ukraine Site 78 Zaporizhzhia
United States Site 19 Cincinnati Ohio
United States Site 14 Denver Colorado
United States Site 25 Glendale Arizona
United States Site 26 Lebanon New Hampshire
United States Site 23 Lexington Kentucky
United States Site 18 Memphis Tennessee
United States Site 17 Middleburg Heights Ohio
United States Site 20 Monroe Louisiana
United States Site 16 Phoenix Arizona
United States Site 24 Salisbury North Carolina
United States Site 21 Seattle Washington
United States Site 22 Spokane Washington
United States Site 27 Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Sun Pharmaceutical Industries Limited

Countries where clinical trial is conducted

United States,  Argentina,  Hungary,  Mexico,  Poland,  Russian Federation,  Spain,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with adverse events and its relationship to investigational medicinal product will be assessed by the Investigator (Global Introspection assessment) upto week 208
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