NCT03897075.

Study name	Efficacy and safety study of tildrakizumab in the treatment of nail psoriasis
Methods	RCT, parallel arms, double‐blind, multicentric Location ? Phase 3
Participants	Randomised: 146 Inclusion criteria: 18 years or older Patients with a chronic moderate‐to‐severe plaque‐type psoriasis for at least 6 months Patients must have moderate‐to‐severe nail psoriasis at screening and baseline Patients must be considered candidates for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy Patients have a negative evaluation for tuberculosis within 4 weeks before initiating study treatment, defined as a negative QuantiFERON® test Participants with a positive or 2 successive indeterminate QuantiFERON® tests Participants must have results of a physical examination within normal limits or clinically acceptable limits to the Investigator prior to Day 1 Exclusion criteria: Patients 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 Patients with ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails which may potentially confound the evaluation of study treatment Patients with fungal nail infection should be excluded from the study Women of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the study), or are lactating Patients with any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to screening, or severe infection (e.g. pneumonia, cellulitis, bone or joint infections) requiring hospitalisation or treatment with intravenous antibiotics within 6 weeks prior to screening Patients with any previous use of tildrakizumab or other IL‐23/Th‐17 pathway inhibitors, including p40, p19 and IL‐17 antagonists for psoriasis Prior use of TNF‐alpha inhibitors with a wash‐out period of 12 weeks would be allowed. However, the number of patients with prior use of TNF‐alpha inhibitors would be capped at 40% and the analysis will be stratified based on prior use of these biologics Patients with a positive human immunodeficiency virus test result, hepatitis B surface antigen, or hepatitis C virus test result Patients with a prior malignancy or concurrent malignancy (excluding successfully‐treated basal cell carcinoma, squamous cell carcinoma of the skin in situ, squamous cell carcinoma of skin with no evidence of recurrence within 5 years or carcinoma in situ of the cervix that has been adequately treated) Patients who have received live viral or bacterial vaccination within 4 weeks prior to baseline or who intend to receive live viral or bacterial vaccination during the study Patients who were hospitalised due to an acute cardiovascular event (such as myocardial infarction, cerebrovascular accident, cardiovascular illness [e.g., angina pectoris], or cardiovascular surgery [such as coronary artery bypass]) within 6 months before screening Patients who have a history of alcohol or drug abuse in the previous year Patients who have high risk of suicidality at the screening assessment based on Investigator's judgement or, if appropriate, as indicated by a response of "yes" within the last 12 months to Questions 4 or 5 in the suicidal ideation section, or any positive response in the behavioural section of the Columbia‐Suicide Severity Rating Scale
Interventions	Intervention: Tildrakizumab Comparator: Placebo
Outcomes	Primary Outcome: The proportion of participants who achieve "clear" or "minimal" with a ≥ 2‐grade improvement from baseline on the Physician's Global Assessment of Finger Nail Psoriasis scale at week 28 The percentage of participants with incidence, seriousness, and severity of all adverse events week 52 The percentage of participants with severe infections, whether or not reported as a serious event defined as any infection meeting the regulatory definition of a serious adverse event, or any infection requiring intravenous antibiotics. week 52 The percentage of participants with malignancies (excluding carcinoma in situ of the cervix). week 52 The percentage of participants with non‐melanoma skin cancer. week 52 The percentage of participants with melanoma skin cancer. week 52 The percentage of participants with Major Adverse Cardiovascular Events. week 52 The percentage of participants with study treatment‐related hypersensitivity reactions (e.g. anaphylaxis, urticaria, angioedema, etc). week 52 The percentage of participants with injection site reactions. week 52 Secondary Outcome: The proportion of participants who achieve at least a 75% improvement from baseline in total‐modified Nail Psoriasis Severity Index. week 28 The proportion of participants achieving total‐fingernail total‐modified Nail Psoriasis Severity Index I90, and total‐modified Nail Psoriasis Severity Index 100. week 28 The proportion of participants achieving total‐fingernail Nail Psoriasis Severity Index 75, Nail Psoriasis Severity Index 90, and Nail Psoriasis Severity Index 100. week 28 Mean percentage change in total‐fingernail modified Nail Psoriasis Severity Index score from baseline. week 28 Mean percentage change in total‐fingernail Nail Psoriasis Severity Index score from baseline. week 28 Mean change in participant‐reported nail pain numeric rating scale score from baseline. week 28 The proportion of participants with a 4‐point decrease in Nail Pain numeric rating scale score from baseline, among those with baseline Nail Pain NRS of ≥ 4. week 28 The proportion of participants achieving Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90, and Psoriasis Area and Severity Index 100 week 28 The proportion of participants achieving Physician's Global Assessment score of "clear" or "almost clear" with at least 2‐point reduction from baseline. week 28 Mean percentage change in total body surface area involvement from baseline. week 28 Other Outcome Change from baseline in modified Nail Psoriasis Severity Index week 52 Change from baseline in Dermatology Life Quality Index score, Nail Psoriasis Functional Severity Score, and Nail Assessment in Psoriasis and Psoriatic Arthritis QoL score. week 52
Starting date	Estimated study start date: September 2020 Estimated study completion date: April 2024 Last update posted: July 2020, not yet recruiting
Contact information	Head, Clinical development91 2266455645clinical.trials@sparcmail.com
Notes	Funding: Sun Pharma Global FZE