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New drug shows promise for psoriatic arthritis in major trial

NCT ID NCT04314531

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tests whether tildrakizumab, an injected drug, can reduce joint pain and swelling in people with active psoriatic arthritis who have not used anti-TNF treatments before. About 296 adults will receive either the drug or a placebo. The main goal is to see if at least 20% improvement in symptoms is achieved.

What this could mean

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

Active substance
tildrakizumab
What this could lead to
If successful, tildrakizumab could offer a new treatment option for people with active psoriatic arthritis who haven't tried anti-TNF therapies.
What could go wrong
This is a late-stage trial, but results may not apply to everyone. Some participants may not respond, and side effects are possible, as with any drug.

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

296 people

The number who actually took part.

Started

Jul 2020

Expected to finish

Apr 2026

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: 1. Subject has provided written informed consent. 2. Subject is ≥ 18 years of age at time of Screening. 3. Subject has a diagnosis of active PsA for at least 6 months before the first administration of the study agent and has active PsA at Screening or Baseline. 4. Rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibodies (anti-CCP Ab) negative. 5. Subjects must have no prior exposure to anti-tumor necrosis factor (anti-TNF) agent(s) use for the treatment of PsO or PsA. Exclusion Criteria: 1. The subject has a planned surgical intervention between Baseline and the Week 52 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 intravenous (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 any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could cause this study to be detrimental to the subject. 4. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus. 5. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose. 6. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma. 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 signing the Informed Consent and through 24 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 follicle-stimulating hormone (FSH) test should be performed to confirm menopause (per reference values of the laboratory) 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 milliliter (mL) or more of blood within 8 weeks before first dose of IMP. 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

  • Sunpharma Site 100

    Madrid, 28046, Spain

  • Sunpharma Site 106

    Lucknow, Uttar Pradesh, 226003, India

  • Sunpharma Site 107

    Belagavi, Karnataka, 590016, India

  • Sunpharma Site 108

    Pune, Maharashtra, 411004, India

  • Sunpharma Site 109

    Hubli, Karnataka, 580021, India

  • Sunpharma Site 110

    Bangalore, Karnataka, 560079, India

  • Sunpharma Site 111

    Surat, Gujarat, 395010, India

  • Sunpharma Site 112

    Hyderabad, Telangana, 500003, India

  • Sunpharma Site 113

    Kochi, 682040, India

  • Sunpharma Site 18

    Incheon, 22332, South Korea

  • Sunpharma Site 19

    Seoul, 4763, South Korea

  • Sunpharma Site 20

    Seoul, 3080, South Korea

  • Sunpharma Site 22

    Kitakyushu-shi, 802-8561, Japan

  • Sunpharma Site 23

    Tsu, 514-8507, Japan

  • Sunpharma Site 24

    Miyazaki, Miyazaki, 889-1692, Japan

  • Sunpharma Site 39

    Phillip, Australian Capital Territory, 2606, Australia

  • Sunpharma Site 63

    Zlín, 760 01, Czechia

  • Sunpharma Site 64

    Brno, 638 00, Czechia

  • Sunpharma Site 71

    Córdoba, 14004, Spain

  • Sunpharma Site 72

    Seville, 41013, Spain

  • Sunpharma Site 73

    Berlin, 12161, Germany

  • Sunpharma Site 74

    Poznan, 61-113, Poland

  • Sunpharma Site 75

    A Coruña, 15006, Spain

  • Sunpharma Site 84

    Nagoya, Aichi-ken, 467-0001, Japan

  • Sunpharma Site 85

    Shinjuku, Tokyo, 160-0023, Japan

  • Sunpharma Site 86

    Sendai, Miyagi, 980-8574, Japan

  • Sunpharma Site 87

    Osaka, 545-0051, Japan

  • Sunpharma Site 88

    Kumamoto, 860-8556, Japan

  • Sunpharma Site 89

    Kitakyushu, Fukuoka, 802-8561, Japan

  • Sunpharma Site 90

    tabashi City, Tokyo, 173-8606, Japan

  • Sunpharma Site 91

    Mitaka, Tokyo, 181-8611, Japan

  • Sunpharma Site 92

    Herne, 44649, Germany

  • Sunpharma Site 93

    Bialystok, 15-351, Poland

  • Sunpharma Site 94

    Lublin, 20-607, Poland

  • Sunpharma Site 95

    Bialystok, 15-879, Poland

  • Sunpharma Site 96

    Warsaw, 02-118, Poland

  • Sunpharma Site 97

    Prague, 12800, Czechia

  • Sunpharma site no. 01

    Tomball, Texas, 77375, United States

  • Sunpharma site no. 02

    New Port Richey, Florida, 34652, United States

  • Sunpharma site no. 03

    San Antonio, Texas, 78229, United States

  • Sunpharma site no. 04

    Miami Beach, Florida, 33140, United States

  • Sunpharma site no. 05

    Springfield, Missouri, 65810, United States

  • Sunpharma site no. 06

    Spokane, Washington, 99204, United States

  • Sunpharma site no. 07

    Tamarac, Florida, 33321, United States

  • Sunpharma site no. 08

    Hobart, Tasmania, 7000, Australia

  • Sunpharma site no. 09

    Lubbock, Texas, 79410, United States

  • Sunpharma site no. 10

    Lincoln, Nebraska, 68516, United States

  • Sunpharma site no. 11

    Greenville, South Carolina, 29601, United States

  • Sunpharma site no. 12

    Covina, California, 91722, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.