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New hope for psoriatic arthritis: tildrakizumab shows promise in Long-Term trial

NCT ID NCT04991116

Disease control Sponsor: Sun Pharmaceutical Industries Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 3 study is testing the long-term safety and effectiveness of tildrakizumab, a biologic drug given as an injection, in people with psoriatic arthritis. Researchers are tracking side effects and how well the drug reduces joint pain, swelling, and other symptoms over time. The study includes 529 participants who previously completed a related trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tildrakizumab (a biologic drug given as a shot under the skin)
What this could lead to
If successful, this could confirm tildrakizumab as a safe, long-term option to control joint pain and swelling in psoriatic arthritis.
What could go wrong
This is an extension study, so participants already responded well in an earlier trial. Results may not apply to all patients, and long-term side effects are still being tracked.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

529 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

psoriatic arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Psoriatic arthritis

Contacts and locations

Locations

  • SunPharma Site No 23

    Córdoba, 14004, Spain

  • SunPharma Site no 22

    Tamarac, Florida, 33321, United States

  • Sunpharma Site no 27

    Lincoln, Nebraska, 68516, United States

  • Sunpharma Site no 28

    Lubbock, Texas, 79410, United States

  • Sunpharma site no 100

    Bangalore, Tamil Nadu, 560010, India

  • Sunpharma site no 101

    Belagavi, Karnataka, 590016, India

  • Sunpharma site no 102

    Secunderabad, 500003, India

  • Sunpharma site no 103

    Chennai, Tamil Nadu, 600086, India

  • Sunpharma site no 104

    St Louis, Missouri, 63119, United States

  • Sunpharma site no 105

    Phoenix, Arizona, 85032, United States

  • Sunpharma site no 106

    Olsztyn, Poland

  • Sunpharma site no 107

    Margate, Florida, 33063, United States

  • Sunpharma site no 108

    Pune, Maharashtra, 411004, India

  • Sunpharma site no 109

    Mesquite, Texas, 75150, United States

  • Sunpharma site no 110

    Encino, California, 91436, United States

  • Sunpharma site no 111

    Leland, North Carolina, 28451, United States

  • Sunpharma site no 112

    Wroclaw, 52-416, Poland

  • Sunpharma site no 113

    Avon Park, Florida, 33825, United States

  • Sunpharma site no 114

    Pune, 411007, India

  • Sunpharma site no 31

    Greenville, South Carolina, 29601, United States

  • Sunpharma site no 32

    Ocoee, Florida, 34751, United States

  • Sunpharma site no 33

    Voorhees Township, New Jersey, 08043, United States

  • Sunpharma site no 34

    Charlotte, North Carolina, 28204, United States

  • Sunpharma site no 35

    Minot, North Dakota, 58701, United States

  • Sunpharma site no 36

    Brno, 638 00, Czechia

  • Sunpharma site no 37

    Berlin, 12161, Germany

  • Sunpharma site no 38

    Córdoba, 14004, Spain

  • Sunpharma site no 39

    Tartu, 50106, Estonia

  • Sunpharma site no 40

    Tartu, 50708, Estonia

  • Sunpharma site no 42

    Nové Mesto nad Váhom, 915 01, Slovakia

  • Sunpharma site no 43

    Bialystok, 15-351, Poland

  • Sunpharma site no 44

    Tallinn, 10117, Estonia

  • Sunpharma site no 45

    Fukuoka, 802-8561, Japan

  • Sunpharma site no 46

    Kumamoto, 860-8556, Japan

  • Sunpharma site no 47

    Skokie, Illinois, 60076, United States

  • Sunpharma site no 48

    Kalispell, Montana, 59901, United States

  • Sunpharma site no 49

    Schaumburg, Illinois, 60195, United States

  • Sunpharma site no 50

    Dothan, Alabama, 36305, United States

  • Sunpharma site no 51

    Orland Park, Illinois, 60467, United States

  • Sunpharma site no 52

    Gainesville, Georgia, 30501, United States

  • Sunpharma site no 53

    Wilmington, North Carolina, 28401, United States

  • Sunpharma site no 54

    Taichung, 402, Taiwan

  • Sunpharma site no 55

    Nadarzyn, 05-830, Poland

  • Sunpharma site no 56

    Krakow, 30-033, Poland

  • Sunpharma site no 57

    A Coruña, 15006, Spain

  • Sunpharma site no 58

    Maroochydore, Queensland, 4558, Australia

  • Sunpharma site no 59

    Phillip, Australian Capital Territory, 2606, Australia

  • Sunpharma site no 60

    Torun, 87-100, Poland

  • Sunpharma site no 61

    Warsaw, 02-118, Poland

  • Sunpharma site no 62

    Seville, 41013, Spain

  • Sunpharma site no 63

    Sendai, 980-8574, Japan

  • Sunpharma site no 64

    Sendai, 545-8586, Japan

  • Sunpharma site no 65

    Mesa, Arizona, 85210, United States

  • Sunpharma site no 66

    Spokane, Washington, 99204, United States

  • Sunpharma site no 67

    Prague, 12800, Czechia

  • Sunpharma site no 68

    Poznan, 61-113, Poland

  • Sunpharma site no 69

    Bialystok, 15-879, Poland

  • Sunpharma site no 70

    Seoul, 3080, South Korea

  • Sunpharma site no 71

    Kissimmee, Florida, 34744, United States

  • Sunpharma site no 72

    Mitaka, 181-8611, Japan

  • Sunpharma site no 73

    Shinjuku-ku, Tokyo, 160-0023, Japan

  • Sunpharma site no 74

    Martin, 036 01, Slovakia

  • Sunpharma site no 75

    Tainan, 710, Taiwan

  • Sunpharma site no 76

    Kaohsiung City, 833, Taiwan

  • Sunpharma site no 77

    Taipei, 112, Taiwan

  • Sunpharma site no 79

    Miyazaki, 889-1692, Japan

  • Sunpharma site no 80

    Gilbert, Arizona, 85297, United States

  • Sunpharma site no 81

    Lublin, 20-607, Poland

  • Sunpharma site no 82

    Zlín, 760 01, Czechia

  • Sunpharma site no 83

    Herne, 44649, Germany

  • Sunpharma site no 84

    Itabashi-ku, 173-8606, Japan

  • Sunpharma site no 86

    Málaga, 29009, Spain

  • Sunpharma site no 87

    Tsu, Japan

  • Sunpharma site no 88

    Santiago de Compostela, 15706, Spain

  • Sunpharma site no 89

    Prague, 140 00, Czechia

  • Sunpharma site no 90

    Verona, 37134, Italy

  • Sunpharma site no 91

    Hubli, Karnataka, 580021, India

  • Sunpharma site no 92

    Surat, Gujarat, 395010, India

  • Sunpharma site no 93

    Chennai, Tamil Nadu, 600004, India

  • Sunpharma site no 94

    Sevilla, 41014, India

  • Sunpharma site no 95

    Trois-Rivières, G9A 3X2, Canada

  • Sunpharma site no 96

    Salt Lake City, Utah, 84132, United States

  • Sunpharma site no 97

    Valencia, 46010, Spain

  • Sunpharma site no 99

    Taichung, 40705, Taiwan

  • Sunpharma site no. 01

    Tomball, Texas, 77375, United States

  • Sunpharma site no. 02

    Hialeah, Florida, 33016, United States

  • Sunpharma site no. 03

    San Antonio, Texas, 78229, United States

  • Sunpharma site no. 05

    New Port Richey, Florida, 34652, United States

  • Sunpharma site no. 08

    Baytown, Texas, 77521, United States

  • Sunpharma site no. 11

    Middleburg Heights, Ohio, 44130, United States

  • Sunpharma site no. 13

    Baytown, Texas, 77521, United States

  • Sunpharma site no. 14

    Springfield, Missouri, 65807, United States

  • Sunpharma site no. 15

    Thousand Oaks, California, 91320, United States

  • Sunpharma site no. 16

    San Antonio, Texas, 78229, United States

  • Sunpharma site no. 17

    Fountain Valley, California, 92708, United States

  • Sunpharma site no. 20

    Wichita, Kansas, 67207, United States

  • Sunpharma site no. 21

    Clearwater, Florida, 33765, United States

  • Sunpharma site no. 24

    Hobart, Tasmania, 7000, Australia

  • Sunpharma site no. 30

    Covina, California, 91722, United States

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