Active Psoriatic ArthritisPhase 3NCT04314531
Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)
A Phase 3 study testing TILD in people with Active Psoriatic Arthritis, run by Sun Pharmaceutical Industries Limited at 49 sites in 9 countries.
Trial summary
This is a randomized, double-blinded, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tildrakizumab compared to placebo in anti-TNF naïve subjects with active PsA . 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
- 296 participants
- Where
- 49 sitesin 9 countries
- Study dates
- 1 Jul 2020to Apr 2026
- 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
- Subject has provided written informed consent.
- Subject is ≥ 18 years of age at time of Screening.
- 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.
- Rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibodies (anti-CCP Ab) negative.
- Subjects must have no prior exposure to anti-tumor necrosis factor (anti-TNF) agent(s) use for the treatment of PsO or PsA.
Who cannot join
- The subject has a planned surgical intervention between Baseline and the Week 52 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 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.
- 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.
Show all 17Show fewer
- Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
- 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.
- 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 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.
- 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 milliliter (mL) or more of blood within 8 weeks before first dose of IMP.
- 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
49 sites in 9 countries.
49 sites in 9 countries
United States11 sites
Sunpharma site no. 12
Covina, California, 91722
Sunpharma site no. 11
Greenville, South Carolina, 29601
Sunpharma site no. 10
Lincoln, Nebraska, 68516
Sunpharma site no. 09
Lubbock, Texas, 79410
Sunpharma site no. 04
Miami Beach, Florida, 33140
Sunpharma site no. 02
New Port Richey, Florida, 34652
Sunpharma site no. 03
San Antonio, Texas, 78229
Sunpharma site no. 06
Spokane, Washington, 99204
Sunpharma site no. 05
Springfield, Missouri, 65810
Sunpharma site no. 07
Tamarac, Florida, 33321
Sunpharma site no. 01
Tomball, Texas, 77375
Japan11 sites
Sunpharma Site 89
Kitakyushu, Fukuoka, 802-8561
Sunpharma Site 22
Kitakyushu-shi, 802-8561
Sunpharma Site 88
Kumamoto, 860-8556
Sunpharma Site 91
Mitaka, Tokyo, 181-8611
Sunpharma Site 24
Miyazaki, Miyazaki, 889-1692
Sunpharma Site 84
Nagoya, Aichi-ken, 467-0001
Sunpharma Site 87
Osaka, 545-0051
Sunpharma Site 86
Sendai, Miyagi, 980-8574
Sunpharma Site 85
Shinjuku, Tokyo, 160-0023
Sunpharma Site 90
tabashi City, Tokyo, 173-8606
Sunpharma Site 23
Tsu, 514-8507
India8 sites
Sunpharma Site 110
Bangalore, Karnataka, 560079
Sunpharma Site 107
Belagavi, Karnataka, 590016
Sunpharma Site 109
Hubli, Karnataka, 580021
Sunpharma Site 112
Hyderabad, Telangana, 500003
Sunpharma Site 113
Kochi, 682040
Sunpharma Site 106
Lucknow, Uttar Pradesh, 226003
Sunpharma Site 108
Pune, Maharashtra, 411004
Sunpharma Site 111
Surat, Gujarat, 395010
Poland5 sites
Sunpharma Site 93
Bialystok, 15-351
Sunpharma Site 95
Bialystok, 15-879
Sunpharma Site 94
Lublin, 20-607
Sunpharma Site 74
Poznan, 61-113
Sunpharma Site 96
Warsaw, 02-118
Spain4 sites
Sunpharma Site 75
A Coruña, 15006
Sunpharma Site 71
Córdoba, 14004
Sunpharma Site 100
Madrid, 28046
Sunpharma Site 72
Seville, 41013
Czechia3 sites
Sunpharma Site 64
Brno, 638 00
Sunpharma Site 97
Prague, 12800
Sunpharma Site 63
Zlín, 760 01
South Korea3 sites
Sunpharma Site 18
Incheon, 22332
Sunpharma Site 20
Seoul, 3080
Sunpharma Site 19
Seoul, 4763
Australia2 sites
Sunpharma site no. 08
Hobart, Tasmania, 7000
Sunpharma Site 39
Phillip, Australian Capital Territory, 2606
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)
This is a randomized, double-blinded, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tildrakizumab compared to placebo in anti-TNF naïve subjects with active PsA .
- Conditions
- Active Psoriatic Arthritis
- 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 group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: TILD |
| Arm B | Placebo comparator | Not described Receives: Drug: matching placebo injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
The change from Baseline in the van der Heijde modified total Sharp score
Measured: Week 24
The change from Baseline in the van der Heijde modified total Sharp score
Measured: at Week 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 and erythrocyte sedimentation rate levels
Measured: at Week 24
The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
Measured: at Week 24
The change from Baseline in Leeds Enthesitis Index
Measured: at Week 24
The change from Baseline in Leeds Dactylitis Index
Measured: at Week 24
The proportion of subjects who achieve a Disease Activity Score-C-reactive protein < 3.2
Measured: at Week 24
The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)
Measured: at Week 24
The proportion of subjects with the Change in van der Heijde modified total Sharp score <0 and < 0.5
Measured: Week 24
The proportion of subjects with active Psoriasis and body surface area ≥3%
Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100
Measured: at Week 24
The change from Baseline in anti-tumor necrosis factor naïve 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
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
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 and erythrocyte sedimentation rate levels
Measured: at week 52
change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
Measured: at Week 52
The change from Baseline in Leeds Enthesitis Index, Leeds Dactylitis Index and Health Assessment Questionnaire Disability Index score
Measured: at Week 52
The proportion of subjects who achieve a Disease Activity Score(28 [joints]-C-reactive protein) < 3.2
Measured: at Week 52
The change from Baseline in van der Heijde modified total Sharp score
Measured: at Week 52
The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)
Measured: at Week 52
The proportion of subjects with the change in van der Heijde modified total Sharp score <0 and < 0.5
Measured: at Week 52
In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥3%, the proportion of subjects with Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100
Measured: at Week 52
In anti-tumor necrosis factor naïve 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
In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥3%, the change from Baseline in Physician Global Assessment-Psoriasis
Measured: at week 52
Change from baseline in health assessment questionnaire - disability index (HAQ-DI) score
Measured: at Week 24
The change from Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components
Measured: measured timepoints
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.
- First posted19 Mar 2020
- Study start1 Jul 2020
- Primary completion4 Jun 2025
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314531
- Sponsor's protocol ID
- TILD-19-19
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2020
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)
- ClinicalTrials.gov ID
- NCT04314531
- Acronym / sponsor ID
- TILD-19-19
- Conditions
- Active Psoriatic Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- Apr 2026 (estimated)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blinded, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tildrakizumab compared to placebo in anti-TNF naïve subjects with active PsA .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: TILD |
| Arm B | Placebo comparator | Drug: matching placebo injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has provided written informed consent.
- Subject is ≥ 18 years of age at time of Screening.
- 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.
- Rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibodies (anti-CCP Ab) negative.
- Subjects must have no prior exposure to anti-tumor necrosis factor (anti-TNF) agent(s) use for the treatment of PsO or PsA.
Key exclusion criteria (17 listed)
- The subject has a planned surgical intervention between Baseline and the Week 52 evaluation for a pretreatment condition.
- Subject has an active infection or history of infections as follows:
- 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.
- Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
- Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TILDone 1 mL injection of study medication | Drug | Arm A |
| matching placebo injectionsone 1 mL injection of placebo | Drug | Arm B |
Primary outcome
The proportion of subjects who achieve American College of Rheumatology [ACR20]
Time frame: at Week 24
the proportion of subjects achieving a 20% reduction from Baseline in response criteria
28 secondary outcomes
The proportion of subjects achieving American College of Rheumatology [ACR50]
Time frame: at Week 24
The proportion of subjects achieving American College of Rheumatology [ACR70]
Time frame: at Week 24
The proportion of subjects achieving Psoriasis Area and Severity Index 75 response among subjects with body surface area ≥3% at baseline
Time frame: at Weeks 24
The change from Baseline in the van der Heijde modified total Sharp score
Time frame: Week 24
The change from Baseline in the van der Heijde modified total Sharp score
Time frame: at Week 16
The Change from Baseline in American College of Rheumatology Response Criteria Components Score
Time frame: at Week 24
The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
Time frame: at Week 24
The change from Baseline in Leeds Enthesitis Index
Time frame: at Week 24
The change from Baseline in Leeds Dactylitis Index
Time frame: at Week 24
The proportion of subjects who achieve a Disease Activity Score-C-reactive protein < 3.2
Time frame: at Week 24
The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)
Time frame: at Week 24
The proportion of subjects with the Change in van der Heijde modified total Sharp score <0 and < 0.5
Time frame: Week 24
The proportion of subjects with active Psoriasis and body surface area ≥3%
Time frame: at Week 24
The change from Baseline in anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥ 3% (those with involvement of nails)
Time frame: at Week 24
The proportion of subjects achieving American College of Rheumatology [ACR20, ACR50 and ACR70]
Time frame: at Week 52
The change from Baseline in American College of Rheumatology Response Criteria Components Score
Time frame: at week 52
change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
Time frame: at Week 52
The change from Baseline in Leeds Enthesitis Index, Leeds Dactylitis Index and Health Assessment Questionnaire Disability Index score
Time frame: at Week 52
The proportion of subjects who achieve a Disease Activity Score(28 [joints]-C-reactive protein) < 3.2
Time frame: at Week 52
The change from Baseline in van der Heijde modified total Sharp score
Time frame: at Week 52
The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)
Time frame: at Week 52
The proportion of subjects with the change in van der Heijde modified total Sharp score <0 and < 0.5
Time frame: at Week 52
In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥3%, the proportion of subjects with Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100
Time frame: at Week 52
In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥3% those with involvement of nails, the change from Baseline in nail psoriasis severity index
Time frame: at Week 52
In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥3%, the change from Baseline in Physician Global Assessment-Psoriasis
Time frame: at week 52
Change from baseline in health assessment questionnaire - disability index (HAQ-DI) score
Time frame: at Week 24
The change from Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components
Time frame: measured timepoints
The change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scores
Time frame: at week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Active Psoriatic Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
Arthritis, Psoriatic
Active, not recruitingPhase 4
A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
Arthritis, Psoriatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
49 sites in 9 countries: see every site and its status.
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 49 sites in 9 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 5 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: under way, not looking for participants, as of the sponsor's last update on 10 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 49 sites in United States, Japan, India, Poland, Spain and 4 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?
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?
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?
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 10 Mar 2026.