MedDataX Logo

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

NCT ID: NCT04991116

Last Updated: 2025-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2029-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

An open label phase 3 study

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Psoriatic Immune Response to Tildrakizumab

NCT05390515

Psoriasis Vulgaris
UNKNOWN PHASE4

Efficacy and Safety of Tildrakizumab 100 Milligrams (mg) in Participants With Moderate-Severe Chronic Plaque Psoriasis and Its Impact on Their Quality of Life (TRIBUTE)

NCT04229836

Plaque Psoriasis
COMPLETED PHASE4

Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

NCT04314544

Active Psoriatic Arthritis
COMPLETED PHASE3

A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis

NCT03718299

Psoriasis
COMPLETED PHASE4

Efficacy and Safety Study of SUNPG1623

NCT02980692

Active Psoriatic Arthritis
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Subjects from both INSPIRE 1 (TILD-19-07) and INSPIRE 2 (TILD-19-19) studies to roll over into this INSPIRE LTE study (TILD-21-01).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriatic Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TILD q12 weeks

Group Type EXPERIMENTAL

TILD sub-cutaneous (SC) injection

Intervention Type DRUG

1 mL injection of study medication

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TILD sub-cutaneous (SC) injection

1 mL injection of study medication

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sun Pharmaceutical Industries Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sunpharma site no 50

Dothan, Alabama, United States

Site Status RECRUITING

Sunpharma site no 80

Gilbert, Arizona, United States

Site Status RECRUITING

Sunpharma site no 65

Mesa, Arizona, United States

Site Status RECRUITING

Sunpharma site no 105

Phoenix, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Sunpharma site no. 30

Covina, California, United States

Site Status RECRUITING

Sunpharma site no 110

Encino, California, United States

Site Status ACTIVE_NOT_RECRUITING

Sunpharma site no. 17

Fountain Valley, California, United States

Site Status RECRUITING

Sunpharma site no. 15

Thousand Oaks, California, United States

Site Status RECRUITING

Sunpharma site no 113

Avon Park, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Sunpharma site no. 21

Clearwater, Florida, United States

Site Status RECRUITING

Sunpharma site no. 02

Hialeah, Florida, United States

Site Status RECRUITING

Sunpharma site no 71

Kissimmee, Florida, United States

Site Status RECRUITING

Sunpharma site no 107

Margate, Florida, United States

Site Status RECRUITING

Sunpharma site no. 05

New Port Richey, Florida, United States

Site Status RECRUITING

Sunpharma site no 32

Ocoee, Florida, United States

Site Status RECRUITING

SunPharma Site no 22

Tamarac, Florida, United States

Site Status RECRUITING

Sunpharma site no 52

Gainesville, Georgia, United States

Site Status RECRUITING

Sunpharma site no 51

Orland Park, Illinois, United States

Site Status RECRUITING

Sunpharma site no 49

Schaumburg, Illinois, United States

Site Status COMPLETED

Sunpharma site no 47

Skokie, Illinois, United States

Site Status RECRUITING

Sunpharma site no. 20

Wichita, Kansas, United States

Site Status ACTIVE_NOT_RECRUITING

Sunpharma site no. 14

Springfield, Missouri, United States

Site Status RECRUITING

Sunpharma site no 104

St Louis, Missouri, United States

Site Status RECRUITING

Sunpharma site no 48

Kalispell, Montana, United States

Site Status RECRUITING

Sunpharma Site no 27

Lincoln, Nebraska, United States

Site Status RECRUITING

Sunpharma site no 33

Voorhees Township, New Jersey, United States

Site Status RECRUITING

Sunpharma site no 34

Charlotte, North Carolina, United States

Site Status RECRUITING

Sunpharma site no 111

Leland, North Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Sunpharma site no 53

Wilmington, North Carolina, United States

Site Status RECRUITING

Sunpharma site no 35

Minot, North Dakota, United States

Site Status RECRUITING

Sunpharma site no. 11

Middleburg Heights, Ohio, United States

Site Status RECRUITING

Sunpharma site no 31

Greenville, South Carolina, United States

Site Status COMPLETED

Sunpharma site no. 08

Baytown, Texas, United States

Site Status TERMINATED

Sunpharma site no. 13

Baytown, Texas, United States

Site Status RECRUITING

Sunpharma Site no 28

Lubbock, Texas, United States

Site Status RECRUITING

Sunpharma site no 109

Mesquite, Texas, United States

Site Status RECRUITING

Sunpharma site no. 03

San Antonio, Texas, United States

Site Status NOT_YET_RECRUITING

Sunpharma site no. 16

San Antonio, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Sunpharma site no. 01

Tomball, Texas, United States

Site Status RECRUITING

Sunpharma site no 96

Salt Lake City, Utah, United States

Site Status RECRUITING

Sunpharma site no 66

Spokane, Washington, United States

Site Status RECRUITING

Sunpharma site no 59

Phillip, Australian Capital Territory, Australia

Site Status RECRUITING

Sunpharma site no 58

Maroochydore, Queensland, Australia

Site Status RECRUITING

Sunpharma site no. 24

Hobart, Tasmania, Australia

Site Status TERMINATED

Sunpharma site no 95

Trois-Rivières, , Canada

Site Status RECRUITING

Sunpharma site no 36

Brno, , Czechia

Site Status RECRUITING

Sunpharma site no 67

Prague, , Czechia

Site Status RECRUITING

Sunpharma site no 89

Prague, , Czechia

Site Status RECRUITING

Sunpharma site no 82

Zlín, , Czechia

Site Status RECRUITING

Sunpharma site no 44

Tallinn, , Estonia

Site Status RECRUITING

Sunpharma site no 39

Tartu, , Estonia

Site Status RECRUITING

Sunpharma site no 40

Tartu, , Estonia

Site Status RECRUITING

Sunpharma site no 37

Berlin, , Germany

Site Status RECRUITING

Sunpharma site no 83

Herne, , Germany

Site Status RECRUITING

Sunpharma site no 92

Surat, Gujarat, India

Site Status RECRUITING

Sunpharma site no 101

Belagavi, Karnataka, India

Site Status RECRUITING

Sunpharma site no 91

Hubli, Karnataka, India

Site Status RECRUITING

Sunpharma site no 108

Pune, Maharashtra, India

Site Status RECRUITING

Sunpharma site no 100

Bangalore, Tamil Nadu, India

Site Status RECRUITING

Sunpharma site no 93

Chennai, Tamil Nadu, India

Site Status RECRUITING

Sunpharma site no 103

Chennai, Tamil Nadu, India

Site Status RECRUITING

Sunpharma site no 114

Pune, , India

Site Status RECRUITING

Sunpharma site no 102

Secunderabad, , India

Site Status ACTIVE_NOT_RECRUITING

Sunpharma site no 94

Sevilla, , India

Site Status RECRUITING

Sunpharma site no 90

Verona, , Italy

Site Status RECRUITING

Sunpharma site no 73

Shinjuku-ku, Tokyo, Japan

Site Status RECRUITING

Sunpharma site no 45

Fukuoka, , Japan

Site Status RECRUITING

Sunpharma site no 84

Itabashi-ku, , Japan

Site Status RECRUITING

Sunpharma site no 46

Kumamoto, , Japan

Site Status RECRUITING

Sunpharma site no 72

Mitaka, , Japan

Site Status RECRUITING

Sunpharma site no 79

Miyazaki, , Japan

Site Status RECRUITING

Sunpharma site no 78

Nagoya, , Japan

Site Status WITHDRAWN

Sunpharma site no 64

Sendai, , Japan

Site Status RECRUITING

Sunpharma site no 63

Sendai, , Japan

Site Status RECRUITING

Sunpharma site no 87

Tsu, , Japan

Site Status RECRUITING

Sunpharma site no 43

Bialystok, , Poland

Site Status RECRUITING

Sunpharma site no 69

Bialystok, , Poland

Site Status RECRUITING

Sunpharma site no 56

Krakow, , Poland

Site Status RECRUITING

Sunpharma site no 81

Lublin, , Poland

Site Status RECRUITING

Sunpharma site no 55

Nadarzyn, , Poland

Site Status RECRUITING

Sunpharma site no 106

Olsztyn, , Poland

Site Status ACTIVE_NOT_RECRUITING

Sunpharma site no 85

Poznan, , Poland

Site Status WITHDRAWN

Sunpharma site no 68

Poznan, , Poland

Site Status RECRUITING

Sunpharma site no 60

Torun, , Poland

Site Status RECRUITING

Sunpharma site no 61

Warsaw, , Poland

Site Status RECRUITING

Sunpharma site no 112

Wroclaw, , Poland

Site Status ACTIVE_NOT_RECRUITING

Sunpharma site no 74

Martin, , Slovakia

Site Status RECRUITING

Sunpharma site no 42

Nové Mesto nad Váhom, , Slovakia

Site Status RECRUITING

Sunpharma site no 41

Rimavská Sobota, , Slovakia

Site Status WITHDRAWN

Sunpharma site no 98

Seoul, , South Korea

Site Status WITHDRAWN

Sunpharma site no 70

Seoul, , South Korea

Site Status RECRUITING

Sunpharma site no 57

A Coruña, , Spain

Site Status RECRUITING

SunPharma Site No 23

Córdoba, , Spain

Site Status RECRUITING

Sunpharma site no 38

Córdoba, , Spain

Site Status RECRUITING

Sunpharma site no 86

Málaga, , Spain

Site Status ACTIVE_NOT_RECRUITING

Sunpharma site no 88

Santiago de Compostela, , Spain

Site Status ACTIVE_NOT_RECRUITING

Sunpharma site no 62

Seville, , Spain

Site Status RECRUITING

Sunpharma site no 97

Valencia, , Spain

Site Status ACTIVE_NOT_RECRUITING

Sunpharma site no 76

Kaohsiung City, , Taiwan

Site Status RECRUITING

Sunpharma site no 54

Taichung, , Taiwan

Site Status RECRUITING

Sunpharma site no 99

Taichung, , Taiwan

Site Status RECRUITING

Sunpharma site no 75

Tainan City, , Taiwan

Site Status RECRUITING

Sunpharma site no 77

Taipei, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Canada Czechia Estonia Germany India Italy Japan Poland Slovakia South Korea Spain Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Head, Clinical Developement

Role: CONTACT

[email protected]
9122 66455645 ext. 5689

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TILD-21-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011)
NCT01729754 COMPLETED PHASE3
A Study to Evaluate the Efficacy and Safety of Subcutaneous MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-010)
NCT01722331 COMPLETED PHASE3
A Study to Determine the Optimal Dose of Tildrakizumab (SCH 900222/MK-3222) for the Treatment of Moderate-to-severe Chronic Plaque Psoriasis (P05495) (MK-3222-003)
NCT01225731 COMPLETED PHASE2
A Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis.
NCT06611163 ACTIVE_NOT_RECRUITING PHASE3
A Phase Ⅲ Study to Evaluate Tildrakizumab in the Treatment of Chinese Subjects With Moderate to Severe Plaquetype Psoriasis
NCT05108766 COMPLETED PHASE3
Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis
NCT03897075 COMPLETED PHASE3
A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents
NCT01077362 COMPLETED PHASE3
Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasis
NCT03897088 COMPLETED PHASE3
Observational Real-world Evidence (RWE) Study to Assess Patient-reported Wellbeing Using Tildrakizumab in Live Setting - POSITIVE Study
NCT04823247 COMPLETED
A Study of Picankibart in Patients With Active Psoriatic Arthritis
NCT07295509 NOT_YET_RECRUITING PHASE2/PHASE3
Long-Term Treatment Effect With Tildrakizumab in Participants With Plaque Psoriasis
NCT04339595 TERMINATED PHASE4
A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis
NCT06030076 RECRUITING
A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
NCT02584855 COMPLETED PHASE3
A Study of LY3361237 in Participants With Psoriasis
NCT04975295 COMPLETED PHASE1
A Study of Ixekizumab in Participants With Active Psoriatic Arthritis
NCT01695239 COMPLETED PHASE3
A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis
NCT05364554 COMPLETED PHASE2
Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Psoriatic Arthritis
NCT01860976 COMPLETED PHASE3
Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight
NCT06588296 ACTIVE_NOT_RECRUITING PHASE3
Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis
NCT01892436 COMPLETED PHASE3
Psoriatic Arthritis Study of Izokibep
NCT05623345 TERMINATED PHASE2/PHASE3
24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis
NCT01989468 COMPLETED PHASE3
A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis
NCT03418493 COMPLETED PHASE1
To Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis
NCT05495568 COMPLETED PHASE3
An Open-Label Study to Assess Safety
NCT03645499 COMPLETED PHASE1
Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors
NCT01882439 COMPLETED PHASE3