Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

Study Purpose

This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque 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 2 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male and female subjects ages 2 to 17 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 3 months prior to the baseline visit.
  • - Subject with plaque psoriasis covering ≥ 3% of the BSA at screening and baseline.
  • - A PGA score of ≥ 2 at screening and baseline.
  • - Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods.
  • - Must not be pregnant.
  • - Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent.

Exclusion Criteria:

  • - Psoriasis other than plaque variant.
  • - Any sign of infection of any of the psoriatic lesions.
  • - Immunocompromised at screening.
  • - Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN) - Screening total bilirubin > 1.5x ULN.
  • - Current or chronic history of liver disease.
  • - Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix.
  • - Major surgery within 8 weeks prior to baseline or has a major surgery planned during the study.
  • - Known history of clinically significant drug or alcohol abuse in the last year prior to baseline.
  • - Use of any prohibited medication or procedure within the indicated period before the baseline visit until the completion of the study completion or study discontinuation.
  • - History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion may interfere with the subject's participation in the study, interpretation of results, safety of the subject or ability to understand and give informed consent.
  • - Pregnant or lactating females.
  • - History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation.
- Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)

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.

NCT05172726
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.

Dermavant Sciences, Inc.
Principal Investigator

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

Diana Villalobos
Principal Investigator Affiliation Dermavant Sciences, Inc.
Agency Class

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

Industry
Overall Status Recruiting
Countries Canada, United States
Conditions

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

Plaque Psoriasis
Additional Details

This study is an open-label study, consisting of a 12-week primary treatment phase and an optional 40-week long-term extension phase in which all eligible subjects will receive tapinarof cream, 1% once daily. At the end of the 12-week primary treatment phase subjects will have the option to continue for 40 additional weeks of treatment. Subjects who choose not to participate in the optional 40-week long-term extension phase will complete a follow-up visit approximately one week after the end of the primary treatment phase.

Arms & Interventions

Arms

Experimental: Open Label

Interventions

Drug: - tapinarof cream, 1%

applied topically once daily

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.

Dermavant Clinical Site, Rogers, Arkansas

Status

Recruiting

Address

Dermavant Clinical Site

Rogers, Arkansas, 72758

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Site, Fountain Valley, California

Status

Recruiting

Address

Dermavant Clinical Site

Fountain Valley, California, 92708

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Site, Rancho Santa Margarita, California

Status

Recruiting

Address

Dermavant Clinical Site

Rancho Santa Margarita, California, 92688

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Site, Clearwater, Florida

Status

Recruiting

Address

Dermavant Clinical Site

Clearwater, Florida, 33759

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Site, Miami Lakes, Florida

Status

Recruiting

Address

Dermavant Clinical Site

Miami Lakes, Florida, 45324

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Site, Chicago, Illinois

Status

Recruiting

Address

Dermavant Clinical Site

Chicago, Illinois, 60611

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Site, Indianapolis, Indiana

Status

Recruiting

Address

Dermavant Clinical Site

Indianapolis, Indiana, 46250

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Site, West Lafayette, Indiana

Status

Recruiting

Address

Dermavant Clinical Site

West Lafayette, Indiana, 47906

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Site, Fairborn, Ohio

Status

Recruiting

Address

Dermavant Clinical Site

Fairborn, Ohio, 45324

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Site, Portland, Oregon

Status

Recruiting

Address

Dermavant Clinical Site

Portland, Oregon, 97210

Site Contact

Dermavant Clinical Site

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Site, Spokane, Washington

Status

Recruiting

Address

Dermavant Clinical Site

Spokane, Washington, 92688

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Site, Spokane, Washington

Status

Recruiting

Address

Dermavant Clinical Site

Spokane, Washington, 99202

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

International Sites

Dermavant Clinical Site, Calgary, Alberta, Canada

Status

Recruiting

Address

Dermavant Clinical Site

Calgary, Alberta, T2J7E1

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Site, Edmonton, Alberta, Canada

Status

Recruiting

Address

Dermavant Clinical Site

Edmonton, Alberta, T5J3S9

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Site, Saint John's, Newfoundland and Labrador, Canada

Status

Recruiting

Address

Dermavant Clinical Site

Saint John's, Newfoundland and Labrador, A1E1V4

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Site, Markham, Ontario, Canada

Status

Recruiting

Address

Dermavant Clinical Site

Markham, Ontario, L3P1X3

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Trials, Oshawa, Ontario, Canada

Status

Recruiting

Address

Dermavant Clinical Trials

Oshawa, Ontario, L1H1B9

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Site, Waterloo, Ontario, Canada

Status

Recruiting

Address

Dermavant Clinical Site

Waterloo, Ontario, N2J1C4

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

Dermavant Clinical Site, Montréal, Quebec, Canada

Status

Recruiting

Address

Dermavant Clinical Site

Montréal, Quebec, H2X2V1

Site Contact

Dermavant Clinical Trials

dermavantclinicaltrials@dermavant.com

480-666-0844

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