Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis

NCT04991116 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: TILD-21-01
• Study Type: interventional
• Target: 529
• Locations: 13 countries
• Sites: 96

Brief Summary

An open label phase 3 study

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (4)

• Incidence and intensity of Adverse Events (AEs) recorded through the study period

  Week 124

• Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20

  ACR20 response is an aggregate of: 1\. at least 20% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments: 1. physician's global assessment of disease activity 2. patient's global assessment of disease activity 3. patient's assessment of pain 4. patient's self-assessed disability based on health assessment questionnaire 5. c-reactive protein

  Week 124

• Proportion of Subjects Who Reached (American College of Rheumatology Score of 50) ACR50

  ACR50 response is an aggregate of: 1\. at least 50% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments: 1. physician's global assessment of disease activity 2. patient's global assessment of disease activity 3. patient's assessment of pain 4. patient's self-assessed disability based on health assessment questionnaire 5. c-reactive protein

  Week 124

• Proportion of Subjects Who Reached (American College of Rheumatology Score of 70) ACR70

  ACR70 response is an aggregate of: 1\. at least 70% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments: 1. physician's global assessment of disease activity 2. patient's global assessment of disease activity 3. patient's assessment of pain 4. patient's self-assessed disability based on health assessment questionnaire 5. c-reactive protein

  Week 124

Study Arms (1)

TILD q12 weeks

EXPERIMENTAL

Drug: TILD sub-cutaneous (SC) injection

Interventions

TILD sub-cutaneous (SC) injection DRUG

1 mL injection of study medication

TILD q12 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects possess the ability to understand the requirements of the study.
• Subject has provided written informed consent as evidenced by signature on an informed consent form approved by an institutional review board/EC.
• Agree to abide by the study restrictions, scheduled treatment, laboratory assessments, other study procedures and return to the site for the required assessments.
• Subject with PsA who had met all eligibility criteria for the parent study, had completed the parent study treatment period and has not developed any parent protocol criteria for premature discontinuation of treatment or withdrawal from the study.

You may not qualify if:

• Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception.
• Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 17 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (99)

Sunpharma site no 50

Dothan, Alabama, 36305, United States

Location

Sunpharma site no 80

Gilbert, Arizona, 85297, United States

Location

Sunpharma site no 65

Mesa, Arizona, 85210, United States

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Sunpharma site no 105

Phoenix, Arizona, 85032, United States

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Sunpharma site no. 30

Covina, California, 91722, United States

Location

Sunpharma site no 110

Encino, California, 91436, United States

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Sunpharma site no. 17

Fountain Valley, California, 92708, United States

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Sunpharma site no. 15

Thousand Oaks, California, 91320, United States

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Sunpharma site no 113

Avon Park, Florida, 33825, United States

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Sunpharma site no. 21

Clearwater, Florida, 33765, United States

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Sunpharma site no. 02

Hialeah, Florida, 33016, United States

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Sunpharma site no 71

Kissimmee, Florida, 34744, United States

Location

Sunpharma site no 107

Margate, Florida, 33063, United States

Location

Sunpharma site no. 05

New Port Richey, Florida, 34652, United States

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Sunpharma site no 32

Ocoee, Florida, 34751, United States

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SunPharma Site no 22

Tamarac, Florida, 33321, United States

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Sunpharma site no 52

Gainesville, Georgia, 30501, United States

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Sunpharma site no 51

Orland Park, Illinois, 60467, United States

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Sunpharma site no 49

Schaumburg, Illinois, 60195, United States

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Sunpharma site no 47

Skokie, Illinois, 60076, United States

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Sunpharma site no. 20

Wichita, Kansas, 67207, United States

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Sunpharma site no. 14

Springfield, Missouri, 65807, United States

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Sunpharma site no 104

St Louis, Missouri, 63119, United States

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Sunpharma site no 48

Kalispell, Montana, 59901, United States

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Sunpharma Site no 27

Lincoln, Nebraska, 68516, United States

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Sunpharma site no 33

Voorhees Township, New Jersey, 08043, United States

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Sunpharma site no 34

Charlotte, North Carolina, 28204, United States

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Sunpharma site no 111

Leland, North Carolina, 28451, United States

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Sunpharma site no 53

Wilmington, North Carolina, 28401, United States

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Sunpharma site no 35

Minot, North Dakota, 58701, United States

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Sunpharma site no. 11

Middleburg Heights, Ohio, 44130, United States

Location

Sunpharma site no 31

Greenville, South Carolina, 29601, United States

Location

Sunpharma site no. 08

Baytown, Texas, 77521, United States

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Sunpharma site no. 13

Baytown, Texas, 77521, United States

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Sunpharma Site no 28

Lubbock, Texas, 79410, United States

Location

Sunpharma site no 109

Mesquite, Texas, 75150, United States

Location

Sunpharma site no. 03

San Antonio, Texas, 78229, United States

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Sunpharma site no. 16

San Antonio, Texas, 78229, United States

Location

Sunpharma site no. 01

Tomball, Texas, 77375, United States

Location

Sunpharma site no 96

Salt Lake City, Utah, 84132, United States

Location

Sunpharma site no 66

Spokane, Washington, 99204, United States

Location

Sunpharma site no 59

Phillip, Australian Capital Territory, 2606, Australia

Location

Sunpharma site no 58

Maroochydore, Queensland, 4558, Australia

Location

Sunpharma site no. 24

Hobart, Tasmania, 7000, Australia

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Sunpharma site no 95

Trois-Rivières, G9A 3X2, Canada

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Sunpharma site no 36

Brno, 638 00, Czechia

Location

Sunpharma site no 67

Prague, 12800, Czechia

Location

Sunpharma site no 89

Prague, 140 00, Czechia

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Sunpharma site no 82

Zlín, 760 01, Czechia

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Sunpharma site no 44

Tallinn, 10117, Estonia

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Sunpharma site no 39

Tartu, 50106, Estonia

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Sunpharma site no 40

Tartu, 50708, Estonia

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Sunpharma site no 37

Berlin, 12161, Germany

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Sunpharma site no 83

Herne, 44649, Germany

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Sunpharma site no 92

Surat, Gujarat, 395010, India

Location

Sunpharma site no 101

Belagavi, Karnataka, 590016, India

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Sunpharma site no 91

Hubli, Karnataka, 580021, India

Location

Sunpharma site no 108

Pune, Maharashtra, 411004, India

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Sunpharma site no 100

Bangalore, Tamil Nadu, 560010, India

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Sunpharma site no 93

Chennai, Tamil Nadu, 600004, India

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Sunpharma site no 103

Chennai, Tamil Nadu, 600086, India

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Sunpharma site no 114

Pune, 411007, India

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Sunpharma site no 102

Secunderabad, 500003, India

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Sunpharma site no 94

Sevilla, 41014, India

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Sunpharma site no 90

Verona, 37134, Italy

Location

Sunpharma site no 73

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Sunpharma site no 45

Fukuoka, 802-8561, Japan

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Sunpharma site no 84

Itabashi-ku, 173-8606, Japan

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Sunpharma site no 46

Kumamoto, 860-8556, Japan

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Sunpharma site no 72

Mitaka, 181-8611, Japan

Location

Sunpharma site no 79

Miyazaki, 889-1692, Japan

Location

Sunpharma site no 64

Sendai, 545-8586, Japan

Location

Sunpharma site no 63

Sendai, 980-8574, Japan

Location

Sunpharma site no 87

Tsu, Japan

Location

Sunpharma site no 43

Bialystok, 15-351, Poland

Location

Sunpharma site no 69

Bialystok, 15-879, Poland

Location

Sunpharma site no 56

Krakow, 30-033, Poland

Location

Sunpharma site no 81

Lublin, 20-607, Poland

Location

Sunpharma site no 55

Nadarzyn, 05-830, Poland

Location

Sunpharma site no 106

Olsztyn, Poland

Location

Sunpharma site no 68

Poznan, 61-113, Poland

Location

Sunpharma site no 60

Torun, 87-100, Poland

Location

Sunpharma site no 61

Warsaw, 02-118, Poland

Location

Sunpharma site no 112

Wroclaw, 52-416, Poland

Location

Sunpharma site no 74

Martin, 036 01, Slovakia

Location

Sunpharma site no 42

Nové Mesto nad Váhom, 915 01, Slovakia

Location

Sunpharma site no 70

Seoul, 3080, South Korea

Location

Sunpharma site no 57

A Coruña, 15006, Spain

Location

SunPharma Site No 23

Córdoba, 14004, Spain

Location

Sunpharma site no 38

Córdoba, 14004, Spain

Location

Sunpharma site no 86

Málaga, 29009, Spain

Location

Sunpharma site no 88

Santiago de Compostela, 15706, Spain

Location

Sunpharma site no 62

Seville, 41013, Spain

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Sunpharma site no 97

Valencia, 46010, Spain

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Sunpharma site no 76

Kaohsiung City, 833, Taiwan

Location

Sunpharma site no 54

Taichung, 402, Taiwan

Location

Sunpharma site no 99

Taichung, 40705, Taiwan

Location

Sunpharma site no 75

Tainan, 710, Taiwan

Location

Sunpharma site no 77

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Injections

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 5, 2021
• Study Start: June 30, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (4); CA (1); PL (10); DE (2); SL (2); ES (7); JP (9); US (41); IT (1); AU (3); IN (10); KR (1); TW (5)