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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03897075
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sun Pharmaceutical Industries Limited
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Plaque Psoriasis, Moderate to Severe Nail Psoriasis
Arms & Interventions

Arms

Experimental: Arm A

Placebo Comparator: Arm B

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

California Dermatology & CRI (Site 13), Encinitas, California

Status

Recruiting

Address

California Dermatology & CRI (Site 13)

Encinitas, California, 92007

First OC Dermatology (Site 09), Fountain Valley, California

Status

Recruiting

Address

First OC Dermatology (Site 09)

Fountain Valley, California, 92708

Avance Trials (Site 14), Laguna Niguel, California

Status

Withdrawn

Address

Avance Trials (Site 14)

Laguna Niguel, California, 92677

Los Angeles, California

Status

Recruiting

Address

Dermatology Research Associates (Site 10)

Los Angeles, California, 90045

Clinical Science Institute (Site 05), Santa Monica, California

Status

Recruiting

Address

Clinical Science Institute (Site 05)

Santa Monica, California, 90404

Coral Gables, Florida

Status

Recruiting

Address

Florida Academic Centers Research and Education, LLC (Site 07)

Coral Gables, Florida, 33134

Site 23, Ocala, Florida

Status

Recruiting

Address

Site 23

Ocala, Florida, 34470

Clinical Trials Management,LLC (Site 12), Metairie, Louisiana

Status

Withdrawn

Address

Clinical Trials Management,LLC (Site 12)

Metairie, Louisiana, 70006

Site 24, Troy, Michigan

Status

Withdrawn

Address

Site 24

Troy, Michigan, 48084

Forest Hills Dermatology Group (Site 01), Forest Hills, New York

Status

Recruiting

Address

Forest Hills Dermatology Group (Site 01)

Forest Hills, New York, 11375

Haber Dermatology, Inc. (Site 08), Beachwood, Ohio

Status

Withdrawn

Address

Haber Dermatology, Inc. (Site 08)

Beachwood, Ohio, 44122

Site 25, Mayfield Heights, Ohio

Status

Withdrawn

Address

Site 25

Mayfield Heights, Ohio, 44124

Portland, Oregon

Status

Withdrawn

Address

Oregon Dermatology and Research Center (Site 11)

Portland, Oregon, 97210

Clinical Partners, LLC (Site 03), Johnston, Rhode Island

Status

Recruiting

Address

Clinical Partners, LLC (Site 03)

Johnston, Rhode Island, 02919

Cypress, Texas

Status

Recruiting

Address

Center for Clinical Studies Cypress (Site 06)

Cypress, Texas, 77433

Center for Clinical Studies (Site 04), Houston, Texas

Status

Recruiting

Address

Center for Clinical Studies (Site 04)

Houston, Texas, 77004

Progressive Clinical Research (Site 15), San Antonio, Texas

Status

Recruiting

Address

Progressive Clinical Research (Site 15)

San Antonio, Texas, 78213

Webster, Texas

Status

Withdrawn

Address

Center for Clinical Studies, LTD.LLP (Site 02)

Webster, Texas, 77598

International Sites

Site 20, Kogarah, New South Wales, Australia

Status

Recruiting

Address

Site 20

Kogarah, New South Wales, 2217

Site 22, Kogarah, New South Wales, Australia

Status

Recruiting

Address

Site 22

Kogarah, New South Wales, 2217

Woolloongabba, QSLD, Australia

Status

Recruiting

Address

Veracity Clinical Research/ Specialist Connect(Site 19)

Woolloongabba, QSLD, 4102

Campbelltown, South Australia, Australia

Status

Recruiting

Address

North Eastern Health Specialists (Site 21)

Campbelltown, South Australia, 5073

Skin Health Institute Inc. (Site 18), Carlton, Victoria, Australia

Status

Recruiting

Address

Skin Health Institute Inc. (Site 18)

Carlton, Victoria, 3053

Fremantle Dermatology (Site 16), Fremantle, WAUS, Australia

Status

Recruiting

Address

Fremantle Dermatology (Site 16)

Fremantle, WAUS, 6160

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