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New biologic injection shows promise for psoriatic arthritis in phase 3 trial

NCT ID NCT04314544

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested a single injection of tildrakizumab against placebo in 508 adults with active psoriatic arthritis who had previously used anti-TNF drugs. The main goal was to see if more people achieved at least a 20% improvement in joint symptoms. The study is now complete, and results may support tildrakizumab as a treatment option for this condition.

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 single injection)
What this could lead to
If successful, this could provide a new treatment option for people with active psoriatic arthritis who have not responded well to other therapies.
What could go wrong
This is a single-dose study, so long-term effects and durability are unknown. The trial is also limited to patients who have already tried anti-TNF drugs, so results may not apply to everyone.

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

508 people

The number who actually took part.

Started

Jul 2020

Finished

Dec 2025

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: 1. Subject has provided written informed consent. 2. Subject is ≥ 18 years of age at time of Screening. 3. RF and anti-CCP Ab negative. 4. Subjects must have prior exposure to anti-TNF agent(s) use for the treatment of PsO or PsA. Exclusion Criteria: 1. Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pretreatment condition. 2. Subject has an active infection or history of infections as follows: * any active infection for which systemic anti-infectives were used within 28 days prior to first IMP dose, with the last dose having been received within 7 days of Screening, * a serious infection, defined as requiring hospitalization or IV anti-infectives within 8 weeks prior to the first IMP dose, with the last dose having been received within 7 days of Screening, * recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject. 3. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus. 4. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose. 5. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma. 6. Subject has a history of malignancy within 5 years from the time of Screening EXCEPT treated and considered cured cutaneous basal or squamous cell carcinoma, in situ cervical carcinoma, OR in situ breast ductal carcinoma. 7. Subjects with a history of alcohol or drug abuse in the previous 2 years. 8. 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 17 weeks after the last dose of IMP. If a subject discontinues prematurely, the contraceptive method must be practiced for 17 weeks following final administration of IMP. A FSH test should be performed to confirm menopause for those women with no menses for less than 1 year. 9. Subject currently enrolled in another investigational device/procedure or drug study, or Baseline of this study is less than 30 days or 5 half-lives (whichever is longer) since ending another investigational device/procedure or drug study(s), or receiving other investigational agent(s). 10. Subject previously has been enrolled (randomized) in this study. 11. Subject has any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures. 12. Donation or loss of 400 mL or more of blood within 8 weeks before dosing. 13. Subjects who have been placed in an institution on official or judicial orders. 14. Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest could arise.

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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.

Active psoriatic arthritis

Contacts and locations

Locations

  • Sun pharma site 99

    Brno, 63800, Czechia

  • SunPharma Site No 23

    Córdoba, 14004, Spain

  • SunPharma Site no 22

    Tamarac, Florida, 33321, United States

  • Sunpharma Site no 26

    Stafford, Texas, 77477, United States

  • Sunpharma Site no 27

    Lincoln, Nebraska, 68516, United States

  • Sunpharma Site no 28

    Lubbock, Texas, 79410, United States

  • Sunpharma Site no 29

    Gilbert, Arizona, 85297, United States

  • Sunpharma Site no 30

    Glendale, Arizona, 85306, United States

  • Sunpharma Site no 31

    Mesa, Arizona, 85210, United States

  • Sunpharma Site no 33

    Minot, North Dakota, 58701, United States

  • Sunpharma Site no 34

    Greenville, South Carolina, 29601, United States

  • Sunpharma Site no 35

    Covina, California, 91722, United States

  • Sunpharma Site no 37

    Skokie, Illinois, 60076, United States

  • Sunpharma Site no 38

    Schaumburg, Illinois, 60185, United States

  • Sunpharma Site no 41

    Oak Brook, Illinois, 60523, United States

  • Sunpharma Site no 42

    Dothan, Alabama, 36305, United States

  • Sunpharma Site no 44

    Voorhees Township, New Jersey, 08043, United States

  • Sunpharma Site no 46

    Gainesville, Georgia, 30501, United States

  • Sunpharma Site no 48

    Encino, California, 91436, United States

  • Sunpharma Site no 49

    Colleyville, Texas, 76034, United States

  • Sunpharma Site no 50

    Austin, Texas, 78745, United States

  • Sunpharma Site no 52

    Charlotte, North Carolina, 28204, United States

  • Sunpharma Site no 53

    Kalispell, Montana, 59901, United States

  • Sunpharma Site no 54

    Orland Park, Illinois, 60467, United States

  • Sunpharma Site no 55

    Kissimmee, Florida, 34741, United States

  • Sunpharma Site no 56

    Wilmington, North Carolina, 28401, United States

  • Sunpharma Site no 58

    A Coruña, 15006, Spain

  • Sunpharma Site no 59

    Valencia, 46010, Spain

  • Sunpharma Site no 60

    Tainan, 710, Taiwan

  • Sunpharma Site no 62

    Kaohsiung City, 833, Taiwan

  • Sunpharma Site no 63

    Jianguo, Taichung, 402, Taiwan

  • Sunpharma Site no 64

    Taipei, 112, Taiwan

  • Sunpharma Site no 65

    Taipei, Pai-Tou, 112, Taiwan

  • Sunpharma Site no 70

    Seoul, 4763, South Korea

  • Sunpharma Site no 71

    Seoul, 3080, South Korea

  • Sunpharma Site no. 100

    Prague, 12800, Czechia

  • Sunpharma Site no. 101

    Prague, 14000, Czechia

  • Sunpharma Site no. 103

    Herne, 44649, Germany

  • Sunpharma Site no. 104

    Milan, 20089, Italy

  • Sunpharma Site no. 106

    Ponzan, 60-529, Poland

  • Sunpharma Site no. 107

    Lublin, 20-607, Poland

  • Sunpharma Site no. 108

    Torun, 87-100, Poland

  • Sunpharma Site no. 110

    Bialystok, 15-351, Poland

  • Sunpharma Site no. 111

    Warsaw, 02-118, Poland

  • Sunpharma Site no. 112

    Vahom, 91501, Slovakia

  • Sunpharma Site no. 115

    Santiago de Compostela, 15706, Spain

  • Sunpharma Site no. 116

    Málaga, 29009, Spain

  • Sunpharma Site no. 117

    Seville, 41014, Spain

  • Sunpharma Site no. 121

    Salt Lake City, Utah, 84132, United States

  • Sunpharma Site no. 122

    Skokie, Illinois, 60077, United States

  • Sunpharma Site no. 124

    Oklahoma City, Oklahoma, 73103, United States

  • Sunpharma Site no. 125

    Sabadell, 8208, Spain

  • Sunpharma Site no. 127

    Bangalore, Karnataka, 560079, India

  • Sunpharma Site no. 128

    Mylapore, Chennai, 600004, India

  • Sunpharma Site no. 129

    Lucknow, Uttar Pradesh, 226003, India

  • Sunpharma Site no. 130

    Belagavi, Karnataka, 590016, India

  • Sunpharma Site no. 131

    Pune, Maharashtra, 411004, India

  • Sunpharma Site no. 132

    Hubli, Karnataka, 580021, India

  • Sunpharma Site no. 134

    Surat, Gujarat, 395010, India

  • Sunpharma Site no. 136

    Olsztyn, 10-117, Poland

  • Sunpharma Site no. 137

    Wroclaw, 52-416, Poland

  • Sunpharma Site no. 138

    Verona, 37134, Italy

  • Sunpharma Site no. 139

    Katowice, 40-081, Poland

  • Sunpharma Site no. 141

    Avon Park, Florida, 33825, United States

  • Sunpharma Site no. 142

    Pune, Maharashtra, 411014, India

  • Sunpharma Site no. 143

    Kochi, Kerala, 682040, India

  • Sunpharma Site no. 144

    Kolkata, West Bengal, 700020, India

  • Sunpharma Site no. 73

    Leland, North Carolina, 28451, United States

  • Sunpharma Site no. 74

    Mesquite, Texas, 75150, United States

  • Sunpharma Site no. 75

    Margate, Florida, 33063, United States

  • Sunpharma Site no. 76

    Ocoee, Florida, 34761, United States

  • Sunpharma Site no. 78

    Madrid, 28046, Spain

  • Sunpharma Site no. 79

    Hsinchu, 300, Taiwan

  • Sunpharma Site no. 85

    Tallinn, 10117, Estonia

  • Sunpharma Site no. 86

    Tartu, 50708, Estonia

  • Sunpharma Site no. 87

    Tartu, 50106, Estonia

  • Sunpharma Site no. 88

    Martin, 3601, Slovakia

  • Sunpharma Site no. 91

    Berlin, 12161, Germany

  • Sunpharma Site no. 92

    Poznan, 61-113, Poland

  • Sunpharma Site no. 93

    Bialystok, 15-879, Poland

  • Sunpharma Site no. 94

    Krakow, 30-033, Poland

  • Sunpharma Site no. 95

    Warsaw, Mazowiecki, 05-830, Poland

  • Sunpharma Site no. 96

    Zlín, 760 01, Czechia

  • Sunpharma site 98

    Trois-Rivières, Quebec, G8Z 1Y2, Canada

  • Sunpharma site no. 01

    Tomball, Texas, 77375, United States

  • Sunpharma site no. 02

    Hialeah, Florida, 33016, United States

  • Sunpharma site no. 05

    New Port Richey, Florida, 34652, United States

  • Sunpharma site no. 07

    Worcester, Massachusetts, 01605, United States

  • Sunpharma site no. 08

    Houston, Texas, 77084, 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, 65810, 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

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