Phase 3 Psoriasis Trial, Completed NCT03897075 Sponsor: Sun Pharmaceutical Industries Limited Condition: Psoriasis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 99 people in total — 48 received a placebo (a dummy treatment with no active ingredient) and 51 received a medicine called tildrakizumab at a dose of 100 mg. The trial was looking at nail psoriasis, a condition where psoriasis affects the fingernails or toenails. The main thing researchers were measuring was how many participants saw their nail psoriasis score (using a scale called the mNAPSI) improve by at least 75% after 28 weeks of treatment. By the end of the study, 35 people in the placebo group and 43 in the tildrakizumab group had completed the trial. The reported data shows that at the 28-week mark, about 4.2% of people in the placebo group reached that 75% improvement target, compared with about 25.5% of people in the tildrakizumab group. For the secondary measures, the reported data shows that roughly 4.2% of placebo participants and 29.4% of tildrakizumab participants achieved a near-normal or minimal nail psoriasis rating on a separate assessment tool (called ViSENPsO). Among those who started the trial with notable nail pain, about 25.7% of the placebo group and 45.5% of the tildrakizumab group reported at least a 3-point reduction in their pain score. The trial also tracked adverse events (unwanted health events that occurred during the study). The reported data shows that 39.6% of placebo participants and 54.9% of tildrakizumab participants experienced any adverse event over the course of the study. Serious adverse events were reported in 4.2% of the placebo group and 5.9% of the tildrakizumab group. No participants in either group were reported to have had a severe infection requiring hospital-level antibiotic treatment, and no malignancies (cancers, excluding a specific cervical condition) were reported in the tildrakizumab group, compared with 2.1% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Psoriasis Trial, Completed

NCT03897075
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have had moderate to severe plaque psoriasis (raised, scaly skin patches) for at least 6 months, confirmed by a doctor's examination.
  • Your nail psoriasis is moderate to severe, based on specific scoring measurements taken at your screening and first visits.
  • Your skin psoriasis is moderate to severe, covering at least 10% of your body surface area, also confirmed by scoring at your screening and first visits.
  • Your psoriasis has not been well controlled by treatments such as creams or ointments, light therapy, or previous systemic (whole-body) treatments, and a doctor considers you a candidate for systemic therapy.

Who may not be able to join:

  • You have a type of psoriasis that is mainly not the plaque form, such as a full-body reddening type (erythrodermic), mainly pus-filled blisters type (pustular), a type caused or worsened by medication, or a newly developed guttate (small drop-shaped) psoriasis.
  • You have another ongoing skin condition besides psoriasis, or any other disease affecting your fingernails, that could interfere with how the treatment is evaluated.
  • You have a fungal nail infection, or if testing (such as nail scrapings or nail clipping analysis) shows signs of a fungal nail infection.
  • You have previously used the study drug (tildrakizumab) or similar drugs that work on the same part of the immune system (including biologics such as IL-17 or IL-23 inhibitors) for psoriasis.
  • You have a known allergy or sensitivity to any of the ingredients in the study drug or the placebo (dummy treatment).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Australian sites

Premier Dermatology (Site 47), Kogarah, New South Wales
St George Dermatology & Skin Cancer Centre (Site 45), Kogarah, New South Wales
Veracity Clinical Research/ Specialist Connect(Site 44), Woolloongabba, QSLD
North Eastern Health Specialists (Site 46), Campbelltown, South Australia
Skin Health Institute Inc. (Site 43), Carlton, Victoria
Fremantle Dermatology (Site 40), Fremantle, WAUS

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 3
Sponsor
Sun Pharmaceutical Industries Limited
Registry
ClinicalTrials.gov
Start date
13 May 2021
Est. completion
5 April 2024

Where this trial is recruiting

🇦🇺 Australia 🇺🇸 United States

6 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

The Proportion of Subjects Who Achieve at Least a 75% Improvement From Baseline in Total mNAPSI at Week 28.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov