Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.
- Conditions
- Psoriatic Arthritis
- Interventions
- Drug: SUNPG18_07 I (Tildrakizumab 200 mg)Drug: SUNPG18_07 II (Tildrakizumab 100 mg)
- Registration Number
- NCT03552276
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 281
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SUNPG18_07 q4 Weeks, High Dose to SUNPG18_07 q12 Weeks, Low Dose SUNPG18_07 I (Tildrakizumab 200 mg) Tildrakizumab 200 mg q4 weeks switched to tildrakizumab 100 mg q12 weeks SUNPG18_07 q4 Weeks, High Dose to SUNPG18_07 q12 Weeks, Low Dose SUNPG18_07 II (Tildrakizumab 100 mg) Tildrakizumab 200 mg q4 weeks switched to tildrakizumab 100 mg q12 weeks SUNPG18_07 q12 Weeks, High Dose to SUNPG18_07 q12 Weeks, Low Dose SUNPG18_07 I (Tildrakizumab 200 mg) Tildrakizumab 200 mg q12 weeks switched to tildrakizumab 100 mg q12 weeks SUNPG18_07 q4 weeks, high dose SUNPG18_07 I (Tildrakizumab 200 mg) Tildrakizumab 200 mg q4 Weeks SUNPG18_07 q12 weeks, high dose SUNPG18_07 I (Tildrakizumab 200 mg) Tildrakizumab 200 mg q12 Weeks SUNPG18_07 q12 weeks, low dose SUNPG18_07 II (Tildrakizumab 100 mg) Tildrakizumab 100 mg q12 Weeks SUNPG18_07 q12 Weeks, High Dose to SUNPG18_07 q12 Weeks, Low Dose SUNPG18_07 II (Tildrakizumab 100 mg) Tildrakizumab 200 mg q12 weeks switched to tildrakizumab 100 mg q12 weeks
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events upto week 208 Please refer to Adverse event section for more information
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (66)
Site 25
🇺🇸Glendale, Arizona, United States
Site 16
🇺🇸Phoenix, Arizona, United States
Site 14
🇺🇸Denver, Colorado, United States
Site 27
🇺🇸Wichita, Kansas, United States
Site 23
🇺🇸Lexington, Kentucky, United States
Site 20
🇺🇸Monroe, Louisiana, United States
Site 26
🇺🇸Lebanon, New Hampshire, United States
Site 24
🇺🇸Salisbury, North Carolina, United States
Site 19
🇺🇸Cincinnati, Ohio, United States
Site 17
🇺🇸Middleburg Heights, Ohio, United States
Site 18
🇺🇸Memphis, Tennessee, United States
Site 21
🇺🇸Seattle, Washington, United States
Site 22
🇺🇸Spokane, Washington, United States
Site 02
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Site 01
🇦🇷Mar Del Plata, Buenos Aires, Argentina
Site 03
🇦🇷San Fernando, Buenos Aires, Argentina
Site 32
🇭🇺Budapest, Hungary
Site 34
🇭🇺Budapest, Hungary
Site 33
🇭🇺Kistarcsa, Hungary
Site 06
🇲🇽Monterrey, Nuevo Leon, Mexico
Site 09
🇲🇽Mexico, Distrito Federal, Mexico
Site 05
🇲🇽Mexico City, Mexico, City, Mexico
Site 13
🇲🇽San Luis Potosí, San Luis Potosi, Mexico
Site 04
🇲🇽San Luis Potosí, San Luis Potosi, Mexico
Site 07
🇲🇽Culiacán, Sinaloa, Mexico
Site 12
🇲🇽Mérida, Yucatan, Mexico
Site 11
🇲🇽Chihuahua, Mexico
Site 08
🇲🇽Cuautitlán Izcalli, Mexico
Site 10
🇲🇽Durango, Mexico
Site 45
🇵🇱Kraków, Malopolskie, Poland
Site 38
🇵🇱Białystok, Poland
Site 47
🇵🇱Bytom, Poland
Site 36
🇵🇱Elbląg, Poland
Site 39
🇵🇱Katowice, Poland
Site 40
🇵🇱Katowice, Poland
Site 46
🇵🇱Kraków, Poland
Site 48
🇵🇱Nowa Sól, Poland
Site 42
🇵🇱Poznan, Poland
Site 53
🇵🇱Sochaczew, Poland
Site 50
🇵🇱Warszawa, Poland
Site 52
🇵🇱Warszawa, Poland
Site 51
🇵🇱Wrocław, Poland
Site 43
🇵🇱Łódź, Poland
Site 61
🇷🇺Kemerovo, Kemerovo Region, Russian Federation
Site 58
🇷🇺Novosibirsk, Novosibirsk Oblast, Russian Federation
Site 54
🇷🇺Tomsk, Tomsk Oblast, Russian Federation
Site 56
🇷🇺Izhevsk, Russian Federation
Site 60
🇷🇺Moscow, Russian Federation
Site 57
🇷🇺Saint-Petersburg, Russian Federation
Site 62
🇷🇺Smolensk, Russian Federation
Site 55
🇷🇺Yaroslavl, Russian Federation
Site 59
🇷🇺Yaroslavl, Russian Federation
Site 67
🇪🇸Santiago De Compostela, La Coruna, Spain
Site 65
🇪🇸Málaga, Malaga, Spain
Site 68
🇪🇸Bilbao, Vizcaya, Spain
Site 66
🇪🇸Barcelona, Spain
Site 64
🇪🇸Barcelona, Spain
Site 71
🇪🇸Sevilla, Spain
Site 75
🇺🇦Kharkiv, Ukraine
Site 73
🇺🇦Kiev, Ukraine
Site 74
🇺🇦Kyiv, Ukraine
Site 76
🇺🇦Kyiv, Ukraine
Site 72
🇺🇦Kyiv, Ukraine
Site 77
🇺🇦Odesa, Ukraine
Site 79
🇺🇦Vinnytsya, Ukraine
Site 78
🇺🇦Zaporizhzhia, Ukraine