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

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

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

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: SUNPG18_07 I (Tildrakizumab 200 mg); Drug: SUNPG18_07 II (Tildrakizumab 100 mg)

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.

• Study Type: Interventional
• Enrollment (Actual): 281
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1128AAF
      • Site 02
    • Mar Del Plata, Buenos Aires, Argentina, 7600
      • Site 01
    • San Fernando, Buenos Aires, Argentina, 1646
      • Site 03
• Hungary
  • Budapest, Hungary, 1036
    • Site 32
  • Budapest, Hungary, 1062
    • Site 34
  • Kistarcsa, Hungary, 2143
    • Site 33
• Mexico
  • Chihuahua, Mexico, 31000
    • Site 11
  • Cuautitlán Izcalli, Mexico, 54769
    • Site 08
  • Durango, Mexico, 34080
    • Site 10
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 06700
      • Site 09
  • Mexico, City
    • Mexico City, Mexico, City, Mexico, 7760
      • Site 05
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64020
      • Site 06
  • San Luis Potosi
    • San Luis Potosí, San Luis Potosi, Mexico, 78213
      • Site 13
    • San Luis Potosí, San Luis Potosi, Mexico, 78220
      • Site 04
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80000
      • Site 07
  • Yucatan
    • Mérida, Yucatan, Mexico, 97070
      • Site 12
• Poland
  • Białystok, Poland, 15-879
    • Site 38
  • Bytom, Poland, 41-902
    • Site 47
  • Elbląg, Poland, 82-300
    • Site 36
  • Katowice, Poland, 40-081
    • Site 39
  • Katowice, Poland, 40-282
    • Site 40
  • Kraków, Poland, 30-002
    • Site 46
  • Nowa Sól, Poland, 67-100
    • Site 48
  • Poznan, Poland, 60-848
    • Site 42
  • Sochaczew, Poland, 96-500
    • Site 53
  • Warszawa, Poland, 02-691
    • Site 50
  • Warszawa, Poland, 04-305
    • Site 52
  • Wrocław, Poland, 51-685
    • Site 51
  • Łódź, Poland, 90-265
    • Site 43
  • Malopolskie
    • Kraków, Malopolskie, Poland, 30-510
      • Site 45
• Russian Federation
  • Izhevsk, Russian Federation, 426077
    • Site 56
  • Moscow, Russian Federation, 115404
    • Site 60
  • Saint-Petersburg, Russian Federation, 196084
    • Site 57
  • Smolensk, Russian Federation, 214019
    • Site 62
  • Yaroslavl, Russian Federation, 150003
    • Site 55
  • Yaroslavl, Russian Federation, 150007
    • Site 59
  • Kemerovo Region
    • Kemerovo, Kemerovo Region, Russian Federation, 650066
      • Site 61
  • Novosibirsk Oblast
    • Novosibirsk, Novosibirsk Oblast, Russian Federation, 630099
      • Site 58
  • Tomsk Oblast
    • Tomsk, Tomsk Oblast, Russian Federation, 634050
      • Site 54
• Spain
  • Barcelona, Spain, 08034
    • Site 66
  • Barcelona, Spain, 08035
    • Site 64
  • Sevilla, Spain, 41010
    • Site 71
  • La Coruna
    • Santiago De Compostela, La Coruna, Spain, 15702
      • Site 67
  • Malaga
    • Málaga, Malaga, Spain, 29730
      • Site 65
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Site 68
• Ukraine
  • Kharkiv, Ukraine, 61039
    • Site 75
  • Kiev, Ukraine, 03151
    • Site 73
  • Kyiv, Ukraine, 01023
    • Site 74
  • Kyiv, Ukraine, 02091
    • Site 76
  • Kyiv, Ukraine, 03110
    • Site 72
  • Odesa, Ukraine, 65025
    • Site 77
  • Vinnytsya, Ukraine, 21029
    • Site 79
  • Zaporizhzhia, Ukraine, 69600
    • Site 78
• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Site 25
    • Phoenix, Arizona, United States, 85032
      • Site 16
  • Colorado
    • Denver, Colorado, United States, 80230
      • Site 14
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Site 27
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Site 23
  • Louisiana
    • Monroe, Louisiana, United States, 71203
      • Site 20
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Site 26
  • North Carolina
    • Salisbury, North Carolina, United States, 28144
      • Site 24
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Site 19
    • Middleburg Heights, Ohio, United States, 44130
      • Site 17
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Site 18
  • Washington
    • Seattle, Washington, United States, 98122
      • Site 21
    • Spokane, Washington, United States, 99204
      • Site 22

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SUNPG18_07 q4 weeks, high dose; Tildrakizumab 200 mg q4 Weeks	Drug: SUNPG18_07 I (Tildrakizumab 200 mg); injection
Experimental: SUNPG18_07 q12 weeks, high dose; Tildrakizumab 200 mg q12 Weeks	Drug: SUNPG18_07 I (Tildrakizumab 200 mg); injection
Experimental: SUNPG18_07 q12 weeks, low dose; Tildrakizumab 100 mg q12 Weeks	Drug: SUNPG18_07 II (Tildrakizumab 100 mg); injection
Experimental: SUNPG18_07 q4 Weeks, High Dose to SUNPG18_07 q12 Weeks, Low Dose; Tildrakizumab 200 mg q4 weeks switched to tildrakizumab 100 mg q12 weeks	Drug: SUNPG18_07 I (Tildrakizumab 200 mg); injection; Drug: SUNPG18_07 II (Tildrakizumab 100 mg); injection
Experimental: SUNPG18_07 q12 Weeks, High Dose to SUNPG18_07 q12 Weeks, Low Dose; Tildrakizumab 200 mg q12 weeks switched to tildrakizumab 100 mg q12 weeks	Drug: SUNPG18_07 I (Tildrakizumab 200 mg); injection; Drug: SUNPG18_07 II (Tildrakizumab 100 mg); injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	Please refer to Adverse event section for more information	upto week 208

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries Limited

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2018
• Primary Completion (Actual): September 18, 2023
• Study Completion (Actual): September 18, 2023

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: June 8, 2018
• First Posted (Actual): June 11, 2018

Study Record Updates

• Last Update Posted (Actual): November 21, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic; Immunologic Factors; Physiological Effects of Drugs; Antibodies, Monoclonal
• Other Study ID Numbers: CLR_18_07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No