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Active Psoriatic ArthritisPhase 3NCT04314544

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

A Phase 3 study testing TILD in people with Active Psoriatic Arthritis, run by Sun Pharmaceutical Industries Limited at 97 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Active Psoriatic Arthritis
What is being tested?
TILD
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
508 participants
Where
97 sitesin 12 countries
Study dates
1 Jul 2020to 22 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Subject has provided written informed consent.
  • Subject is ≥ 18 years of age at time of Screening.
  • RF and anti-CCP Ab negative.
  • Subjects must have prior exposure to anti-TNF agent(s) use for the treatment of PsO or PsA.

Who cannot join

  • Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pretreatment condition.
  • 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.
  • Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
Show all 17Show fewer
  • Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose.
  • Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
  • 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.
  • Subjects with a history of alcohol or drug abuse in the previous 2 years.
  • 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.
  • 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).
  • Subject previously has been enrolled (randomized) in this study.
  • 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.
  • Donation or loss of 400 mL or more of blood within 8 weeks before dosing.
  • Subjects who have been placed in an institution on official or judicial orders.
  • Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest could arise.

Trial locations and contacts

97 sites in 12 countries.

97 sites in 12 countries

United States45 sites

  • Sunpharma Site no 50

    Austin, Texas, 78745

  • Sunpharma Site no. 141

    Avon Park, Florida, 33825

  • Sunpharma site no. 13

    Baytown, Texas, 77521

  • Sunpharma Site no 52

    Charlotte, North Carolina, 28204

  • Sunpharma site no. 21

    Clearwater, Florida, 33765

  • Sunpharma Site no 49

    Colleyville, Texas, 76034

  • Sunpharma Site no 35

    Covina, California, 91722

  • Sunpharma Site no 42

    Dothan, Alabama, 36305

  • Sunpharma Site no 48

    Encino, California, 91436

  • Sunpharma site no. 17

    Fountain Valley, California, 92708

  • Sunpharma Site no 46

    Gainesville, Georgia, 30501

  • Sunpharma Site no 29

    Gilbert, Arizona, 85297

  • Sunpharma Site no 30

    Glendale, Arizona, 85306

  • Sunpharma Site no 34

    Greenville, South Carolina, 29601

  • Sunpharma site no. 02

    Hialeah, Florida, 33016

  • Sunpharma site no. 08

    Houston, Texas, 77084

  • Sunpharma Site no 53

    Kalispell, Montana, 59901

  • Sunpharma Site no 55

    Kissimmee, Florida, 34741

  • Sunpharma Site no. 73

    Leland, North Carolina, 28451

  • Sunpharma Site no 27

    Lincoln, Nebraska, 68516

  • Sunpharma Site no 28

    Lubbock, Texas, 79410

  • Sunpharma Site no. 75

    Margate, Florida, 33063

  • Sunpharma Site no 31

    Mesa, Arizona, 85210

  • Sunpharma Site no. 74

    Mesquite, Texas, 75150

  • Sunpharma site no. 11

    Middleburg Heights, Ohio, 44130

  • Sunpharma Site no 33

    Minot, North Dakota, 58701

  • Sunpharma site no. 05

    New Port Richey, Florida, 34652

  • Sunpharma Site no 41

    Oak Brook, Illinois, 60523

  • Sunpharma Site no. 76

    Ocoee, Florida, 34761

  • Sunpharma Site no. 124

    Oklahoma City, Oklahoma, 73103

  • Sunpharma Site no 54

    Orland Park, Illinois, 60467

  • Sunpharma Site no. 121

    Salt Lake City, Utah, 84132

  • Sunpharma site no. 16

    San Antonio, Texas, 78229

  • Sunpharma Site no 38

    Schaumburg, Illinois, 60185

  • Sunpharma Site no 37

    Skokie, Illinois, 60076

  • Sunpharma Site no. 122

    Skokie, Illinois, 60077

  • Sunpharma site no. 14

    Springfield, Missouri, 65810

  • Sunpharma Site no 26

    Stafford, Texas, 77477

  • 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 44

    Voorhees Township, New Jersey, 08043

  • Sunpharma site no. 20

    Wichita, Kansas, 67207

  • Sunpharma Site no 56

    Wilmington, North Carolina, 28401

  • Sunpharma site no. 07

    Worcester, Massachusetts, 01605

Other trials in United States

Poland12 sites

  • Sunpharma Site no. 110

    Bialystok, 15-351

  • Sunpharma Site no. 93

    Bialystok, 15-879

  • Sunpharma Site no. 139

    Katowice, 40-081

  • Sunpharma Site no. 94

    Krakow, 30-033

  • Sunpharma Site no. 107

    Lublin, 20-607

  • Sunpharma Site no. 136

    Olsztyn, 10-117

  • Sunpharma Site no. 106

    Ponzan, 60-529

  • Sunpharma Site no. 92

    Poznan, 61-113

  • Sunpharma Site no. 108

    Torun, 87-100

  • Sunpharma Site no. 95

    Warsaw, Mazowiecki, 05-830

  • Sunpharma Site no. 111

    Warsaw, 02-118

  • Sunpharma Site no. 137

    Wroclaw, 52-416

Other trials in Poland

India10 sites

  • Sunpharma Site no. 127

    Bangalore, Karnataka, 560079

  • Sunpharma Site no. 130

    Belagavi, Karnataka, 590016

  • Sunpharma Site no. 132

    Hubli, Karnataka, 580021

  • Sunpharma Site no. 143

    Kochi, Kerala, 682040

  • Sunpharma Site no. 144

    Kolkata, West Bengal, 700020

  • Sunpharma Site no. 129

    Lucknow, Uttar Pradesh, 226003

  • Sunpharma Site no. 128

    Mylapore, Chennai, 600004

  • Sunpharma Site no. 131

    Pune, Maharashtra, 411004

  • Sunpharma Site no. 142

    Pune, Maharashtra, 411014

  • Sunpharma Site no. 134

    Surat, Gujarat, 395010

Other trials in India

Spain8 sites

  • Sunpharma Site no 58

    A Coruña, 15006

  • SunPharma Site No 23

    Córdoba, 14004

  • Sunpharma Site no. 78

    Madrid, 28046

  • Sunpharma Site no. 116

    Málaga, 29009

  • Sunpharma Site no. 125

    Sabadell, 8208

  • Sunpharma Site no. 115

    Santiago de Compostela, 15706

  • Sunpharma Site no. 117

    Seville, 41014

  • Sunpharma Site no 59

    Valencia, 46010

Other trials in Spain

Taiwan6 sites

  • Sunpharma Site no. 79

    Hsinchu, 300

  • Sunpharma Site no 63

    Jianguo, Taichung, 402

  • Sunpharma Site no 62

    Kaohsiung City, 833

  • Sunpharma Site no 60

    Tainan, 710

  • Sunpharma Site no 65

    Taipei, Pai-Tou, 112

  • Sunpharma Site no 64

    Taipei, 112

Other trials in Taiwan

Czechia4 sites

  • Sun pharma site 99

    Brno, 63800

  • Sunpharma Site no. 100

    Prague, 12800

  • Sunpharma Site no. 101

    Prague, 14000

  • Sunpharma Site no. 96

    Zlín, 760 01

Other trials in Czechia

Estonia3 sites

  • Sunpharma Site no. 85

    Tallinn, 10117

  • Sunpharma Site no. 87

    Tartu, 50106

  • Sunpharma Site no. 86

    Tartu, 50708

Other trials in Estonia

Germany2 sites

  • Sunpharma Site no. 91

    Berlin, 12161

  • Sunpharma Site no. 103

    Herne, 44649

Other trials in Germany

Italy2 sites

  • Sunpharma Site no. 104

    Milan, 20089

  • Sunpharma Site no. 138

    Verona, 37134

Other trials in Italy

Slovakia2 sites

  • Sunpharma Site no. 88

    Martin, 3601

  • Sunpharma Site no. 112

    Vahom, 91501

Other trials in Slovakia

South Korea2 sites

  • Sunpharma Site no 71

    Seoul, 3080

  • Sunpharma Site no 70

    Seoul, 4763

Other trials in South Korea

Canada1 site

  • Sunpharma site 98

    Trois-Rivières, Quebec, G8Z 1Y2

Other trials in Canada

About this study

Official title: A Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

This is a multicenter Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1)

Being tested
TILD, matching placebo injections

What participants receive

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

  • TILDDrug

    one 1 mL injection of study medication

  • matching placebo injectionsDrug

    one 1 mL injection of placebo

Study groups in NCT04314544
Study groupRoleWhat they receive
Arm AExperimentalNot described
Receives: Drug: TILD
Arm BPlacebo comparatorNot described
Receives: Drug: matching placebo injections

What is being measured

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

  1. The proportion of subjects who achieve American College of Rheumatology [ACR20]

    the proportion of subjects achieving a 20% reduction from Baseline in response criteria

    Measured: at week 24

Secondary outcomes (28)

  1. The proportion of subjects achieving American College of Rheumatology [ACR50]

    the proportion of subjects achieving a 50% reduction from Baseline in response criteria

    Measured: at Week 24

  2. The proportion of subjects achieving American College of Rheumatology [ACR70]

    the proportion of subjects achieving a 70% reduction from Baseline in response criteria

    Measured: at Week 24

  3. The proportion of subjects achieving Psoriasis Area and Severity Index 75 response among subjects with Body surface area ≥3% at baseline

    Measured: at Weeks 24

  4. The change from Baseline in the van der Heijde modified total Sharp score

    Measured: at Week 24

  5. The change from Baseline in the van der Heijde modified total Sharp score

    Measured: at Week 16

  6. Change from Baseline in American College of Rheumatology Response Criteria Components Score

    Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 0-100), C-reactive protein levels, Erythrocyte sedimentation rate levels

    Measured: at Week 24

  7. change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index

    Measured: at Week 24

  8. change from Baseline in Leeds Enthesitis Index

    Measured: at Week 24

  9. The change from Baseline in Leeds Dactylitis Index

    Measured: at Week 24

  10. The proportion of subjects who achieve a disease activity score-C-reactive protein < 3.2

    Measured: at Week 24

  11. The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)

    Measured: at Week 24

  12. The proportion of subjects with the Change in van der Heijde modified total Sharp score <0 and < 0.5

    Measured: at Week 24.

  13. The proportion of subjects with active Psoriasis and Body surface area ≥3%

    with: Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100

    Measured: at Week 24

  14. The change from Baseline in subjects with active Psoriasis and Body surface area ≥ 3% ("those with involvement of nails" )

    Physician Global Assessment-Psoriasis and nail psoriasis severity index

    Measured: at Week 24

  15. The proportion of subjects achieving American College of Rheumatology [ACR20, ACR50 and ACR70]

    the proportion of subjects achieving a 20/50/70% reduction from Baseline in response criteria

    Measured: at week 52

  16. The change from Baseline in American College of Rheumatology Response Criteria Components Score

    Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 0-100), C-reactive protein levels, Erythrocyte sedimentation rate levels

    Measured: at Week 52

  17. The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index

    Measured: at Week 52

  18. The change from Baseline

    Leeds Enthesitis Index, Leeds Dactylitis Index, Health Assessment Questionnaire Disability Index Score

    Measured: at Week 52

  19. The proportion of subjects who achieve a Disease Activity Score(28 [joints]-C-reactive protein) < 3.2

    Measured: at Week 52

  20. The change from Baseline in van der Heijde modified total Sharp score

    Measured: at Week 52

  21. The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)

    Measured: at Week 52

  22. The proportion of subjects with the change in van der Heijde modified total Sharp score <0 and < 0.5

    Measured: at Week 52

  23. In subjects with active Psoriasis and Body surface area ≥3%, the proportion of subjects

    Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100

    Measured: at Week 52

  24. In subjects with active Psoriasis and Body surface area ≥3% those with involvement of nails , the change from Baseline in nail psoriasis severity index

    Measured: at Week 52

  25. In subjects with active Psoriasis and Body surface area ≥3%, the change from Baseline in Physician Global Assessment-Psoriasis

    Measured: at Week 52

  26. Change from baseline in health assessment questionnaire - disability index (HAQ-DI) score

    Measured: at Week 24

  27. The change from Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components

    Physical Functioning Domain, Role-Physical Domain, Role-Emotional Domain, Bodily Pain Domain, Mental Health Domain, General Health Domain, Vitality Domain, Social Functioning Domain, Physical Component Summary Score, Mental Component Summary Score

    Measured: Weeks 24 and 52

  28. The change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scores

    Measured: at Week 24

Timeline

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

  1. First posted19 Mar 2020
  2. Study start1 Jul 2020
  3. Primary completion26 Mar 2025
  4. Study completion22 Dec 2025

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
508 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04314544
Sponsor's protocol ID
TILD-19-07
Status last verified
Jan 2026
First submitted
13 Mar 2020
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
Yes
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 in people with Active Psoriatic Arthritis, run by Sun Pharmaceutical Industries Limited at 97 sites in 12 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 17 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: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Poland, India, Spain, Taiwan and 7 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The proportion of subjects who achieve American College of Rheumatology [ACR20] (time frame: at week 24). 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 NCT04314544.

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 16 Jan 2026.

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