Study Comparing Tapinarof Cream 1% to VTAMA ® (Tapinarof Cream 1%) in the Treatment of Plaque Psoriasis

Last updated: December 19, 2024
Sponsor: Teva Pharmaceuticals USA
Overall Status: Active - Recruiting

Phase

3

Condition

Warts

Rash

Scalp Disorders

Treatment

Tapinarof Cream 1%

VTAMA®

Placebo

Clinical Study ID

NCT06742957
72336004
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To compare the safety and efficacy of the test (Tapinarof Cream 1%), placebo (vehicle cream) and reference VTAMA® (Tapinarof Cream 1%) treatments to demonstrate clinical equivalence in patients with plaque psoriasis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed ICF indicating that the patient understands the purpose of, and proceduresrequired for the study and is willing to participate in the study.

  2. Males and non-pregnant, non-lactating females aged ≥18 at the time of signing theinformed consent.

  3. Patients with clinical diagnosis of chronic plaque psoriasis and stable disease forat least 6 months prior to the study.

  4. Body surface area (BSA) involvement ≥ 3% and ≤ 20% (the patient's face, scalp,groins, palms and soles should be excluded from the percent of total BSA (%BSA)calculations).

  5. A Physician's Global Assessment (PGA) score of 2 (mild), 3 (moderate) or 4 (severe)at screening and baseline.

  6. Female patients of childbearing potential (*WOCBP) must not be pregnant or lactatingat the time of screening/baseline visit as documented by a negative urine pregnancytest with a sensitivity to at least 25 mIU/ml hCG:

*Female patients of childbearing potential (WOCBP) are defined as sexually maturewomen without prior hysterectomy, or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for the past 12 or more monthsare still considered to be of childbearing potential, if the amenorrhea is possiblydue to other causes, including prior chemotherapy, anti- estrogens, or ovariansuppression. Postmenopausal women (defined as women who have been amenorrheic for atleast 12 consecutive months, in the appropriate age group, without other known orsuspected primary cause) or women who have been sterilized surgically or who areotherwise proven sterile (i.e., total hysterectomy, or bilateral oophorectomy withsurgery at least 4 weeks prior to randomization) are not considered WOCBP. Patientswho have undergone tubal ligation are NOT considered as surgically sterile.

  1. Female patients of childbearing potential must be willing to use an acceptable formof birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.

  2. For the purposes of this study the following are considered acceptable methodsof birth control: oral or injectable contraceptives, contraceptive patches,medroxyprogesterone acetate (ex. Depo-Provera®) with stabilized use for atleast 3 months, vaginal contraceptive (ex. etonogestrel/ethinyl estradiolvaginal ring (ex. NuvaRing®), contraceptive implant with etonogestrel orequivalent, double barrier methods, (e.g. condom and spermicide), intrauterinedevice (IUD), true abstinence (if in line with patient's lifestyle).

  3. Patients on hormonal contraception must be stabilized on the same type for atleast three months prior to enrollment in the study and must not change themethod during the study. A sterile sexual partner is not considered an adequateform of birth control.

  4. If a patient who was abstinent becomes sexually active during the study, asecond acceptable method of birth control should be used and documented.

  5. Willing and able to adhere to the lifestyle restrictions specified in this protocol.

  6. Patients must be in good health and free from any clinically significant disease,which may interfere with the evaluation of plaque psoriasis or the administration ofthe investigative product.

  7. Patients must be willing to refrain from using all other topical plaque psoriasisproducts during the 12-week treatment period, other than the investigationalproduct.

Exclusion

Exclusion Criteria:

  1. Known allergies, hypersensitivity, or intolerance to any of the ingredients of studytreatment interventions, or components/ excipients thereof (refer to the prescribinginformation of VTAMA®), or drug or other allergy that, in the opinion of theinvestigator, contraindicates participation in the study.

  2. Current diagnosis of unstable forms of psoriasis (other than plaque variant) in thetreatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis.

  3. Patients with other inflammatory skin disease in the treatment area that mayconfound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contactdermatitis, tinea corporis, and or any others in the opinion of the Investigator).

  4. Presence of pigmentation, extensive scarring, or pigmented lesions in the treatmentareas, which could interfere with the rating of efficacy parameters.

  5. Patients with current immunosuppression.

  6. Ultraviolet (UV) light therapy or prolonged exposure to natural or artificialsources of UV radiation (eg, phototherapy, tanning booths, or therapeuticsunbathing), laser therapy, tattoos removal, skin wraps or exfoliant techniques orFraxel within 4 weeks prior to the baseline visit and/or plans to have suchexposures during the study which could potentially impact the patient's psoriasis (as determined by the Investigator).

  7. Use of biological treatments for psoriasis within the last 6 months of the baselineevaluation.

  8. Patients that have been treated with systemic steroids, systemic antibiotics,systemic anti-psoriatic treatment (i.e., methotrexate, cyclosporine, hydroxyurea),PUVA therapy, ultraviolet- B Therapy or systemic anti-inflammatory agents within 1month or within 5 half-lives (whichever is longer) before Baseline.

  9. Use of any of the following therapies within two weeks prior to baseline:

  • topical anti-psoriatic drugs (e.g., salicylic acid, anthralin, coal tar,calcipotriene, tazarotene)

  • topical corticosteroids

  • immunosuppressive drugs (e.g., tacrolimus, pimecrolimus)

  • topical retinoids

  1. Received an investigational intervention within 30 days or 5 half-lives prior to thefirst dose of study intervention, whichever is longer.

  2. Documented medical history of uncontrolled, clinically significant intercurrentmedical condition(s) (i.e., chronic infectious disease, system disorder, organdisorder, cardiovascular, gastrointestinal, hematological, hepatic, neurological,pancreatic, renal disease, severe psychiatric condition, etc.) for which, in theopinion of the investigator, participation would not be in the best interest of thepatient (e.g., compromise the well-being) or that could prevent, limit, or confoundthe protocol-specified assessments.

  3. Employees of the Investigator or research center or their immediate family members.

  4. Females who are pregnant, breast feeding, or who wish to become pregnant during thestudy period.

  5. Patients who have received chemotherapy or radiation therapy and/or anti-neoplasticagents within 3 months prior to screening/baseline.

  6. Patients who are unable or unwilling to give informed consent.

  7. Patients, who in the opinion of the Investigator, would be non-compliant with therequirements of the study protocol.

  8. Patients who consume excessive amounts of alcohol (greater than two drinks per day)or use drugs of abuse (including, but not limited to, cannabinoids, cocaine andbarbiturates) within one year prior to screening.

  9. Patients who have been previously enrolled in this study.

Study Design

Total Participants: 560
Treatment Group(s): 3
Primary Treatment: Tapinarof Cream 1%
Phase: 3
Study Start date:
December 17, 2024
Estimated Completion Date:
November 28, 2025

Study Description

To compare the safety of Test, Reference, and Placebo treatments in patients with Plaque Psoriasis. Patients in this randomized, double-blind, three-arm, placebo controlled, parallel-design, multi-site study will be randomly assigned in a 2:2:1 ratio to treatment with the test product, reference product or placebo control, respectively.

Connect with a study center

  • Site 12107

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Site 12101

    Bryant, Arkansas 72022
    United States

    Site Not Available

  • Site 12110

    Dublin, California 94568
    United States

    Active - Recruiting

  • Site 12112

    Dublin, California 94568
    United States

    Site Not Available

  • Site 12102

    Fremont, California 94538
    United States

    Site Not Available

  • Site 12111

    Pomona, California 91767
    United States

    Site Not Available

  • Site 12115

    Ft. Lauderdale, Florida 33308
    United States

    Active - Recruiting

  • Site 12104

    Miami, Florida 33144
    United States

    Active - Recruiting

  • Site 12113

    Miami, Florida 33175
    United States

    Active - Recruiting

  • Site 12116

    Miami, Florida 33146
    United States

    Active - Recruiting

  • Site 12114

    Miramar, Florida 33027
    United States

    Active - Recruiting

  • Site 12108

    Chicago, Illinois 60614
    United States

    Active - Recruiting

  • Site 12106

    Clarksville, Indiana 47129
    United States

    Site Not Available

  • Site 12105

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Site 12109

    Las Vegas, Nevada 89121
    United States

    Site Not Available

  • Site 12103

    College Station, Texas 77845
    United States

    Site Not Available

  • Site 12117

    Houston, Texas 77070
    United States

    Site Not Available

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