Chronic Plaque PsoriasisPhase 3NCT03897075
Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis
A Phase 3 study testing Tildrakizumab in people with Chronic Plaque Psoriasis and Moderate to Severe Nail Psoriasis, run by Sun Pharmaceutical Industries Limited at 17 sites in 2 countries.
Trial summary
Phase 3b study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Plaque Psoriasis, Moderate to Severe Nail Psoriasis
- What is being tested?
- Tildrakizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 13 May 2021to 30 Jan 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 are eligible to be included in the study only if all of the following criteria apply:
- Subjects with a chronic moderate to severe plaque-type psoriasis for at least 6 months (as determined by subject interview and confirmation of diagnosis through physical examination by Investigator).
- Subjects must have moderate to severe nail psoriasis at Screening and Baseline, defined by:
- mNAPSI score of ≥20.
- ViSENPsO ≥3
- Subjects must have moderate to severe plaque psoriasis at Screening and Baseline, defined by:
Show all 10Show fewer
- s-PGA score of at least 3.
- Body Surface Area (BSA) involvement of ≥10%.
- PASI ≥12
- Subjects must be considered candidates for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.
Who cannot join
- Subjects are excluded from the study if any of the following criteria apply:
- Subjects who have predominantly non-plaque forms of psoriasis, specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced, or medication-exacerbated psoriasis, or new-onset guttate psoriasis.
- Subjects with ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails, which may potentially confound the evaluation of study treatment.
- Subjects with fungal nail infection should be excluded from the study. Subjects in whom the Investigator suspects a fungal nail infection in addition to nail psoriasis should have scrapings sent for direct microscopy and fungal culture. If fungal culture or direct microscopy of nail scrapings turns out to be positive for fungal infection, the subject should be excluded from the study. At the discretion of the investigator, Periodic Acid-Schiff (PAS) staining for nail clippings could also be considered to rule of fungal infection of the nails. Direct microscopy or fungal culture are not required if fungal infection is diagnosed in PAS staining.
- Subjects with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis.
- Subjects with known history of allergy or hypersensitivity to any of the inactive ingredients of the Tildrakizumab or placebo formulations.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States11 sites
Florida Academic Centers Research and Education, LLC (Site 21)
Coral Gables, Florida, 33134
Center for Clinical Studies Cypress (Site 17)
Cypress, Texas, 77433
California Dermatology & CRI (Site 18)
Encinitas, California, 92007
Forest Hills Dermatology Group (Site 04)
Forest Hills, New York, 11375
First OC Dermatology (Site 07)
Fountain Valley, California, 92708
Center for Clinical Studies (Site 11)
Houston, Texas, 77004
Clinical Partners, LLC (Site 08)
Johnston, Rhode Island, 02919
Dermatology Research Associates (Site 09)
Los Angeles, California, 90045
Renstar Medical Research (Site 23)
Ocala, Florida, 34470
Progressive Clinical Research (Site 27)
San Antonio, Texas, 78213
Clinical Science Institute (Site 14)
Santa Monica, California, 90404
Australia6 sites
North Eastern Health Specialists (Site 46)
Campbelltown, South Australia, 5073
Skin Health Institute Inc. (Site 43)
Carlton, Victoria, 3053
Fremantle Dermatology (Site 40)
Fremantle, WAUS, 6160
Premier Dermatology (Site 47)
Kogarah, New South Wales, 2217
St George Dermatology & Skin Cancer Centre (Site 45)
Kogarah, New South Wales, 2217
Veracity Clinical Research/ Specialist Connect(Site 44)
Woolloongabba, QSLD, 4102
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis
Phase 3b study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis
- Being tested
- Tildrakizumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TildrakizumabDrug
PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up
PlaceboDrug
PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: Tildrakizumab |
| Arm B | Placebo comparator | Not described Receives: Drug: Tildrakizumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Subjects Who Achieve at Least a 75% Improvement From Baseline in Total mNAPSI at Week 28.
Primary Efficacy Endpoint
Measured: Week 28
Secondary outcomes (2)
The Proportion of Subjects With a Score of "0 - Normal" or "1 - Minimal Nail Psoriasis" and at Least a 2-point Decrease From Baseline at Week 28 as Measured by the ViSENPsO.
Measured: Week 28
The Proportion of Subjects With at Least 3 Point Decrease From Baseline, in Nail Pain NRS Score in Subjects With Baseline Nail Pain NRS Score of >3
Measured: Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start13 May 2021
- Primary completion5 Apr 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Plaque PsoriasisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 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
- NCT03897075
- Sponsor's protocol ID
- TILD-18-19
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2019
- Last updated
- 1 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis
- ClinicalTrials.gov ID
- NCT03897075
- Acronym / sponsor ID
- TILD-18-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 May 2021 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 3b study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Tildrakizumab |
| Arm B | Placebo comparator | Drug: Tildrakizumab, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects are eligible to be included in the study only if all of the following criteria apply:
- Subjects with a chronic moderate to severe plaque-type psoriasis for at least 6 months (as determined by subject interview and confirmation of diagnosis through physical examination by Investigator).
- Subjects must have moderate to severe nail psoriasis at Screening and Baseline, defined by:
- Subjects must have moderate to severe plaque psoriasis at Screening and Baseline, defined by:
- Subjects must be considered candidates for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.
Key exclusion criteria (6 listed)
- Subjects who have predominantly non-plaque forms of psoriasis, specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced, or medication-exacerbated psoriasis, or new-onset guttate psoriasis.
- Subjects with ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails, which may potentially confound the evaluation of study treatment.
- Subjects with fungal nail infection should be excluded from the study. Subjects in whom the Investigator suspects a fungal nail infection in addition to nail psoriasis should have scrapings sent for direct microscopy and fungal culture. If fungal culture or direct microscopy of nail scrapings turns out to be positive for fungal infection, the subject should be excluded from the study. At the discretion of the investigator, Periodic Acid-Schiff (PAS) staining for nail clippings could also be considered to rule of fungal infection of the nails. Direct microscopy or fungal culture are not required if fungal infection is diagnosed in PAS staining.
- Subjects with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis.
- Subjects with known history of allergy or hypersensitivity to any of the inactive ingredients of the Tildrakizumab or placebo formulations.
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 |
|---|---|---|
| TildrakizumabPART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up | Drug | Arm A, Arm B |
| PlaceboPART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up | Drug | Arm B |
Primary outcome
The Proportion of Subjects Who Achieve at Least a 75% Improvement From Baseline in Total mNAPSI at Week 28.
Time frame: Week 28
Primary Efficacy Endpoint
2 secondary outcomes
The Proportion of Subjects With a Score of "0 - Normal" or "1 - Minimal Nail Psoriasis" and at Least a 2-point Decrease From Baseline at Week 28 as Measured by the ViSENPsO.
Time frame: Week 28
The Proportion of Subjects With at Least 3 Point Decrease From Baseline, in Nail Pain NRS Score in Subjects With Baseline Nail Pain NRS Score of >3
Time frame: Week 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Chronic Plaque Psoriasis
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
Chronic Plaque Psoriasis, Nail Psoriasis
RecruitingPhase 2
Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?
Psoriasis
RecruitingObservational study
Serum Substance P, Neuropathic Pain, and Central Sensitization Across Treatment Groups in Chronic Plaque Psoriasis
Chronic Plaque-type Psoriasis
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.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tildrakizumab in people with Chronic Plaque Psoriasis and Moderate to Severe Nail Psoriasis, run by Sun Pharmaceutical Industries Limited at 17 sites in 2 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 10 inclusion and 6 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 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Australia. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 at Least a 75% Improvement From Baseline in Total mNAPSI at Week 28. (time frame: Week 28). 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 1 Apr 2026.