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New hope for nail psoriasis: tildrakizumab shows promise in trial

NCT ID NCT03897075

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This Phase 3 study tested the drug tildrakizumab in 99 adults with moderate to severe nail psoriasis. Participants received either the drug or a placebo for 28 weeks to see if it improved nail appearance and reduced pain. The trial is complete, and results may help determine if tildrakizumab is a safe and effective treatment 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
What this could lead to
If successful, this could provide a new treatment option for people with stubborn nail psoriasis, improving nail appearance and reducing pain.
What could go wrong
This is a completed Phase 3 trial with 99 participants, so results are specific to this group. Tildrakizumab may not work for everyone and can have side effects like any medication.

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

99 people

The number who actually took part.

Started

May 2021

Finished

Jan 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: Subjects are eligible to be included in the study only if all of the following criteria apply: 1. 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). 2. Subjects must have moderate to severe nail psoriasis at Screening and Baseline, defined by: * mNAPSI score of ≥20. * ViSENPsO ≥3 3. Subjects must have moderate to severe plaque psoriasis at Screening and Baseline, defined by: * s-PGA score of at least 3. * Body Surface Area (BSA) involvement of ≥10%. * PASI ≥12 4. Subjects must be considered candidates for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy. Exclusion Criteria: Subjects are excluded from the study if any of the following criteria apply: 1. 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. 2. 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. 3. 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. 4. Subjects with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis. 5. Subjects with known history of allergy or hypersensitivity to any of the inactive ingredients of the Tildrakizumab or placebo formulations.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • California Dermatology & CRI (Site 18)

    Encinitas, California, 92007, United States

  • Center for Clinical Studies (Site 11)

    Houston, Texas, 77004, United States

  • Center for Clinical Studies Cypress (Site 17)

    Cypress, Texas, 77433, United States

  • Clinical Partners, LLC (Site 08)

    Johnston, Rhode Island, 02919, United States

  • Clinical Science Institute (Site 14)

    Santa Monica, California, 90404, United States

  • Dermatology Research Associates (Site 09)

    Los Angeles, California, 90045, United States

  • First OC Dermatology (Site 07)

    Fountain Valley, California, 92708, United States

  • Florida Academic Centers Research and Education, LLC (Site 21)

    Coral Gables, Florida, 33134, United States

  • Forest Hills Dermatology Group (Site 04)

    Forest Hills, New York, 11375, United States

  • Fremantle Dermatology (Site 40)

    Fremantle, WAUS, 6160, Australia

  • North Eastern Health Specialists (Site 46)

    Campbelltown, South Australia, 5073, Australia

  • Premier Dermatology (Site 47)

    Kogarah, New South Wales, 2217, Australia

  • Progressive Clinical Research (Site 27)

    San Antonio, Texas, 78213, United States

  • Renstar Medical Research (Site 23)

    Ocala, Florida, 34470, United States

  • Skin Health Institute Inc. (Site 43)

    Carlton, Victoria, 3053, Australia

  • St George Dermatology & Skin Cancer Centre (Site 45)

    Kogarah, New South Wales, 2217, Australia

  • Veracity Clinical Research/ Specialist Connect(Site 44)

    Woolloongabba, QSLD, 4102, Australia

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