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Psoriatic ArthritisPhase 3NCT04991116

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

A Phase 3 study testing TILD sub-cutaneous (SC) injection in people with Psoriatic Arthritis, run by Sun Pharmaceutical Industries Limited at 99 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

An open label phase 3 study Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis
What is being tested?
TILD sub-cutaneous (SC) injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
529 participants
Where
99 sitesin 14 countries
Study dates
30 Jun 2022to Apr 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

99 sites in 14 countries.

99 sites in 14 countries

United States41 sites

  • Sunpharma site no 113

    Avon Park, Florida, 33825

  • Sunpharma site no. 08

    Baytown, Texas, 77521

  • Sunpharma site no. 13

    Baytown, Texas, 77521

  • Sunpharma site no 34

    Charlotte, North Carolina, 28204

  • Sunpharma site no. 21

    Clearwater, Florida, 33765

  • Sunpharma site no. 30

    Covina, California, 91722

  • Sunpharma site no 50

    Dothan, Alabama, 36305

  • Sunpharma site no 110

    Encino, California, 91436

  • Sunpharma site no. 17

    Fountain Valley, California, 92708

  • Sunpharma site no 52

    Gainesville, Georgia, 30501

  • Sunpharma site no 80

    Gilbert, Arizona, 85297

  • Sunpharma site no 31

    Greenville, South Carolina, 29601

  • Sunpharma site no. 02

    Hialeah, Florida, 33016

  • Sunpharma site no 48

    Kalispell, Montana, 59901

  • Sunpharma site no 71

    Kissimmee, Florida, 34744

  • Sunpharma site no 111

    Leland, North Carolina, 28451

  • Sunpharma Site no 27

    Lincoln, Nebraska, 68516

  • Sunpharma Site no 28

    Lubbock, Texas, 79410

  • Sunpharma site no 107

    Margate, Florida, 33063

  • Sunpharma site no 65

    Mesa, Arizona, 85210

  • Sunpharma site no 109

    Mesquite, Texas, 75150

  • Sunpharma site no. 11

    Middleburg Heights, Ohio, 44130

  • Sunpharma site no 35

    Minot, North Dakota, 58701

  • Sunpharma site no. 05

    New Port Richey, Florida, 34652

  • Sunpharma site no 32

    Ocoee, Florida, 34751

  • Sunpharma site no 51

    Orland Park, Illinois, 60467

  • Sunpharma site no 105

    Phoenix, Arizona, 85032

  • Sunpharma site no 96

    Salt Lake City, Utah, 84132

  • Sunpharma site no. 03

    San Antonio, Texas, 78229

  • Sunpharma site no. 16

    San Antonio, Texas, 78229

  • Sunpharma site no 49

    Schaumburg, Illinois, 60195

  • Sunpharma site no 47

    Skokie, Illinois, 60076

  • Sunpharma site no 66

    Spokane, Washington, 99204

  • Sunpharma site no. 14

    Springfield, Missouri, 65807

  • Sunpharma site no 104

    St Louis, Missouri, 63119

  • SunPharma Site no 22

    Tamarac, Florida, 33321

  • Sunpharma site no. 15

    Thousand Oaks, California, 91320

  • Sunpharma site no. 01

    Tomball, Texas, 77375

  • Sunpharma site no 33

    Voorhees Township, New Jersey, 08043

  • Sunpharma site no. 20

    Wichita, Kansas, 67207

  • Sunpharma site no 53

    Wilmington, North Carolina, 28401

Other trials in United States

India10 sites

  • Sunpharma site no 100

    Bangalore, Tamil Nadu, 560010

  • Sunpharma site no 101

    Belagavi, Karnataka, 590016

  • Sunpharma site no 93

    Chennai, Tamil Nadu, 600004

  • Sunpharma site no 103

    Chennai, Tamil Nadu, 600086

  • Sunpharma site no 91

    Hubli, Karnataka, 580021

  • Sunpharma site no 108

    Pune, Maharashtra, 411004

  • Sunpharma site no 114

    Pune, 411007

  • Sunpharma site no 102

    Secunderabad, 500003

  • Sunpharma site no 94

    Sevilla, 41014

  • Sunpharma site no 92

    Surat, Gujarat, 395010

Other trials in India

Poland10 sites

  • Sunpharma site no 43

    Bialystok, 15-351

  • Sunpharma site no 69

    Bialystok, 15-879

  • Sunpharma site no 56

    Krakow, 30-033

  • Sunpharma site no 81

    Lublin, 20-607

  • Sunpharma site no 55

    Nadarzyn, 05-830

  • Sunpharma site no 106

    Olsztyn

  • Sunpharma site no 68

    Poznan, 61-113

  • Sunpharma site no 60

    Torun, 87-100

  • Sunpharma site no 61

    Warsaw, 02-118

  • Sunpharma site no 112

    Wroclaw, 52-416

Other trials in Poland

Japan9 sites

  • Sunpharma site no 45

    Fukuoka, 802-8561

  • Sunpharma site no 46

    Kumamoto, 860-8556

  • Sunpharma site no 72

    Mitaka, 181-8611

  • Sunpharma site no 79

    Miyazaki, 889-1692

  • Sunpharma site no 64

    Sendai, 545-8586

  • Sunpharma site no 63

    Sendai, 980-8574

  • Sunpharma site no 73

    Shinjuku-ku, Tokyo, 160-0023

  • Sunpharma site no 84

    tabashi City, 173-8606

  • Sunpharma site no 87

    Tsu

Other trials in Japan

Spain7 sites

  • Sunpharma site no 57

    A Coruña, 15006

  • SunPharma Site No 23

    Córdoba, 14004

  • Sunpharma site no 38

    Córdoba, 14004

  • Sunpharma site no 86

    Málaga, 29009

  • Sunpharma site no 88

    Santiago de Compostela, 15706

  • Sunpharma site no 62

    Seville, 41013

  • Sunpharma site no 97

    Valencia, 46010

Other trials in Spain

Taiwan5 sites

  • Sunpharma site no 76

    Kaohsiung City, 833

  • Sunpharma site no 54

    Taichung, 402

  • Sunpharma site no 99

    Taichung, 40705

  • Sunpharma site no 75

    Tainan, 710

  • Sunpharma site no 77

    Taipei, 112

Other trials in Taiwan

Czechia4 sites

  • Sunpharma site no 36

    Brno, 638 00

  • Sunpharma site no 67

    Prague, 12800

  • Sunpharma site no 89

    Prague, 140 00

  • Sunpharma site no 82

    Zlín, 760 01

Other trials in Czechia

Australia3 sites

  • Sunpharma site no. 24

    Hobart, Tasmania, 7000

  • Sunpharma site no 58

    Maroochydore, Queensland, 4558

  • Sunpharma site no 59

    Phillip, Australian Capital Territory, 2606

Other trials in Australia

Estonia3 sites

  • Sunpharma site no 44

    Tallinn, 10117

  • Sunpharma site no 39

    Tartu, 50106

  • Sunpharma site no 40

    Tartu, 50708

Other trials in Estonia

Germany2 sites

  • Sunpharma site no 37

    Berlin, 12161

  • Sunpharma site no 83

    Herne, 44649

Other trials in Germany

Slovakia2 sites

  • Sunpharma site no 74

    Martin, 036 01

  • Sunpharma site no 42

    Nové Mesto nad Váhom, 915 01

Other trials in Slovakia

Canada1 site

  • Sunpharma site no 95

    Trois-Rivières, G9A 3X2

Other trials in Canada

Italy1 site

  • Sunpharma site no 90

    Verona, 37134

Other trials in Italy

South Korea1 site

  • Sunpharma site no 70

    Seoul, 3080

Other trials in South Korea

About this study

Official title: An Open-Label Extension Study to Evaluate Long Term Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis.

An open label phase 3 study

Read the detailed description

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).

Being tested
TILD sub-cutaneous (SC) injection
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TILD sub-cutaneous (SC) injectionDrug

    1 mL injection of study medication

Study groups in NCT04991116
Study groupRoleWhat they receive
TILD q12 weeksExperimentalNot described
Receives: Drug: TILD sub-cutaneous (SC) injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 124

  2. 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:
    2. physician's global assessment of disease activity
    3. patient's global assessment of disease activity
    4. patient's assessment of pain
    5. patient's self-assessed disability based on health assessment questionnaire
    6. c-reactive protein

    Measured: Week 124

  3. 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:
    2. physician's global assessment of disease activity
    3. patient's global assessment of disease activity
    4. patient's assessment of pain
    5. patient's self-assessed disability based on health assessment questionnaire
    6. c-reactive protein

    Measured: Week 124

  4. 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:
    2. physician's global assessment of disease activity
    3. patient's global assessment of disease activity
    4. patient's assessment of pain
    5. patient's self-assessed disability based on health assessment questionnaire
    6. c-reactive protein

    Measured: Week 124

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2021
  2. Study start30 Jun 2022
  3. Primary completionDec 2028 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
529 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04991116
Sponsor's protocol ID
TILD-21-01
Status last verified
Mar 2026
First submitted
29 Jul 2021
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TILD sub-cutaneous (SC) injection in people with Psoriatic Arthritis, run by Sun Pharmaceutical Industries Limited at 99 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, India, Poland, Japan, Spain and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and intensity of Adverse Events (AEs) recorded through the study period (time frame: Week 124). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04991116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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