Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.

Psoriatic Arthritis Clinical Trial

Official title:

A Long-Term Extension Study to Demonstrate Safety of Tildrakizumab in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552276
• Other study ID #: CLR_18_07
• Status: Completed
• Phase: Phase 2/Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

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