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Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897075
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : February 24, 2022
Sponsor:
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited

Brief Summary:
Phase 3b study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Moderate to Severe Nail Psoriasis Drug: Tildrakizumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 13, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Arm A Drug: Tildrakizumab
PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up

Placebo Comparator: Arm B Drug: Tildrakizumab
PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up

Drug: Placebo
PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up




Primary Outcome Measures :
  1. The proportion of subjects with, at least, a score of "0 - normal" or "1 - minimal nail psoriasis" and a 2-point decrease from baseline as measured by the ViSENPsO. [ Time Frame: Week 28 ]
    Primary Efficacy Endpoint


Secondary Outcome Measures :
  1. The proportion of subjects who achieve at least a 75% improvement from baseline in total-mNAPSI [ Time Frame: Week 28 ]
  2. 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 ]

Other Outcome Measures:
  1. The percentage of subjects with incidence, seriousness, and severity of all adverse events. [ Time Frame: Week 52 ]
    Primary Safety Endpoint

  2. The percentage of subjects 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. [ Time Frame: Week 52 ]
    Primary Safety Endpoint

  3. The percentage of subjects with malignancies (excluding carcinoma in situ of the cervix). [ Time Frame: Week 52 ]
    Primary Safety Endpoint

  4. The percentage of subjects with non-melanoma skin cancer. [ Time Frame: Week 52 ]
    Primary Safety Endpoint

  5. The percentage of subjects with Major Adverse Cardiovascular Events. [ Time Frame: Week 52 ]
    Primary Safety Endpoint

  6. The percentage of subjects with melanoma skin cancer. [ Time Frame: Week 52 ]
    Primary Safety Endpoint

  7. The percentage of subjects with injection site reactions (eg. pain, erythema, edema etc) [ Time Frame: Week 52 ]
    Primary Safety Endpoint

  8. The percentage of subjects with study treatment related hypersensitivity reactions (eg, anaphylaxis, urticaria, angioedema, etc). [ Time Frame: Week 52 ]
    Primary Safety Endpoint



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897075


Contacts
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Contact: Head, Clinical development 91 2266455645 Clinical.Trial@sunpharma.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Sun Pharmaceutical Industries Limited
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Responsible Party: Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier: NCT03897075    
Other Study ID Numbers: TILD-18-19
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases