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

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ClinicalTrials.gov Identifier: NCT03897075
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

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 : 146 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
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

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 who achieve "clear" or "minimal" with a ≥ 2-grade improvement from Baseline on the Physician's Global Assessment of Finger Nail Psoriasis scale [ Time Frame: Week 28 ]
  2. The percentage of subjects with incidence, seriousness, and severity of all adverse events. [ Time Frame: Week 52 ]
  3. 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 ]
  4. The percentage of subjects with malignancies (excluding carcinoma in situ of the cervix). [ Time Frame: Week 52 ]
  5. The percentage of subjects with non-melanoma skin cancer. [ Time Frame: Week 52 ]
  6. The percentage of subjects with melanoma skin cancer. [ Time Frame: Week 52 ]
  7. The percentage of subjects with Major Adverse Cardiovascular Events. [ Time Frame: Week 52 ]
  8. The percentage of subjects with study treatment related hypersensitivity reactions (eg, anaphylaxis, urticaria, angioedema, etc). [ Time Frame: Week 52 ]
  9. The percentage of subjects with injection site reactions (eg. pain, erythema, edema etc) [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. The proportion of subjects who achieve at least a 75% improvement from Baseline in total-modified Nail Psoriasis Severity Index. [ Time Frame: Week 28 ]
  2. The proportion of subjects achieving total-fingernail total-modified Nail Psoriasis Severity Index I90, and total-modified Nail Psoriasis Severity Index 100. [ Time Frame: Week 28 ]
  3. The proportion of subjects achieving total-fingernail Nail Psoriasis Severity Index 75, Nail Psoriasis Severity Index 90, and Nail Psoriasis Severity Index 100. [ Time Frame: Week 28 ]
  4. Mean percentage change in total-fingernail modified Nail Psoriasis Severity Index score from Baseline. [ Time Frame: Week 28 ]
  5. Mean percentage change in total-fingernail Nail Psoriasis Severity Index score from Baseline. [ Time Frame: Week 28 ]
  6. Mean change in patient reported nail pain numeric rating scale score from Baseline [ Time Frame: Week 28 ]
  7. The proportion of subjects with a 4-point decrease in Nail Pain numeric rating scale score from Baseline, among subjects with Baseline Nail Pain NRS of ≥ 4. [ Time Frame: Week 28 ]
  8. The proportion of subjects achieving Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90, and Psoriasis Area and Severity Index 100 [ Time Frame: Week 28 ]
  9. The proportion of subjects achieving Physician's Global Assessment score of "clear" or "almost clear" with at least 2-point reduction from Baseline [ Time Frame: Week 28 ]
  10. Mean percentage change in total body surface area involvement from Baseline [ Time Frame: Week 28 ]

Other Outcome Measures:
  1. Change from Baseline in modified Nail Psoriasis Severity Index [ Time Frame: Week 52 ]
  2. Change from Baseline in Dermatology Life Quality Index score (total and 6 domain scores), Nail Psoriasis Functional Severity Score, and Nail Assessment in Psoriasis and Psoriatic Arthritis QoL score [ Time Frame: Week 52 ]


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:

  1. Subjects should be 18 years or older at the time of signing the informed consent during the Screening visit.
  2. 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).
  3. Subjects must have moderate to severe nail psoriasis at Screening and Baseline, defined by:

    • modified Nail Psoriasis Severity Index score of ≥20
    • fingernail involvement ≥3 on a 5-point Physician's Global Assessment of Finger Nail Psoriasis
  4. Subjects must have moderate to severe plaque psoriasis at Screening and Baseline, defined by:

    • Physician's Global Assessment for Skin of at least moderate severity (score of ≥3 on a 5-point scale)
    • Psoriasis Area and Severity Index score of ≥12
    • Body Surface Area involvement of ≥10%
  5. Subjects must be considered candidates for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.
  6. Subjects has a negative evaluation for tuberculosis within 4 weeks before initiating study treatment, defined as a negative QuantiFERON® test. Subjects with a positive or 2 successive indeterminate QuantiFERON® tests are allowed if they have all of the following:

    • No history of active tuberculosis or symptoms of tuberculosis
    • A postero-anterior chest radiogram (with associated report available at study center) performed within 3 months of Screening with no evidence of active tuberculosis (or of any other pulmonary infectious diseases)
    • If prior latent tuberculosis infection, must have history of adequate prophylaxis (per local standard of care)
    • If presence of latent tuberculosis infection is established, then treatment according to local country guidelines must have been followed for 4 weeks, prior to inclusion in the study.

    A maximum of 2 QuantiFERON® tests are allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used.

  7. Subjects are unlikely to conceive, as indicated by at least one "Yes" answer to the following questions:

    • Subject is a male
    • Subject is a female and agrees to abstain from heterosexual activity OR use a highly effective method of contraception
    • Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (eg, condom) if not surgically sterile (ie, vasectomy)
    • Subject is a surgically sterilized female or is documented to be postmenopausal.
  8. For women of childbearing potential, a negative serum pregnancy test at Screening and a negative urine pregnancy test within 24 hours prior to Day 1 and on subsequent visits at which study treatment doses are scheduled.
  9. Subjects must have results of a physical examination within normal limits or clinically acceptable limits to the Investigator prior to Day 1. The Investigator is encouraged to consult with the Medical Monitor (or appropriate designee) if there are questions regarding the significance of any out-of-range values.
  10. Subjects must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.

Exclusion Criteria:

  1. Subjects who have laboratory abnormalities at Screening including any of the following:

    • Alanine aminotransferase or aspartate aminotransferase ≥2.5 × the upper limit of normal
    • Creatinine ≥2 × the upper limit of normal
    • Serum direct bilirubin ≥1.5 mg/dL
    • White blood cell count <3.0 × 103/μL
    • Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results.
  2. 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.
  3. 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.
  4. Subjects with fungal nail infection should be excluded from the study. Subjects in whom the Investigator suspects a fungal nail infection* (see Appendix 8) in addition to nail psoriasis should have scrapings sent for direct microscopy and fungal culture. If fungal culture or direct microscopy of nail scrapings turn out to be positive for fungal infection, the subject should be excluded from the study. *Subjects with fungal nail infection whose fungal culture will be sent to laboratory would have a Screening Period of 6 weeks.
  5. Women of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the study), or are lactating.
  6. Subjects with any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (eg, pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with intravenous antibiotics within 6 weeks prior to Screening.
  7. Subjects 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 subjects 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.

  8. Subjects with a positive human immunodeficiency virus test result, hepatitis B surface antigen, or hepatitis C virus test result.
  9. Subjects 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).
  10. Subjects 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.
  11. Subjects who are currently participating in another interventional clinical study or has participated in an interventional clinical study within 5 half-lives (of the drug) to wash out prior to randomization. (Subjects participating in observational studies or non- interventional registry studies may be included in the study).
  12. Subjects or a family member is among the personnel of the study center or Sponsor/designee staff directly involved with this study.
  13. Subjects who have any concomitant medical condition which in the opinion of the Investigator could affect the study outcome or present an unacceptable risk.
  14. Subjects who were hospitalized due to an acute cardiovascular event (such as myocardial infarction, cerebrovascular accident, cardiovascular illness [eg, angina pectoris], or cardiovascular surgery [such as coronary artery bypass]) within 6 months before Screening.
  15. Subjects who, in the opinion of the Investigator, will not be a reliable participant in the study and those who can confound the results of the study.
  16. Subjects who have a history of alcohol or drug abuse in the previous year.
  17. Subjects who have high risk of suicidality at the Screening assessment based on Investigator's judgment 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 behavioral section of the Columbia-Suicide Severity Rating Scale.
  18. Subjects with any other clinically significant laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results.

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.trials@sparcmail.com

Sponsors and Collaborators
Sun Pharma Global FZE

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Responsible Party: Sun Pharma Global FZE
ClinicalTrials.gov Identifier: NCT03897075     History of Changes
Other Study ID Numbers: TILD-18-19
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs