COMPLETED

Study Comparing Tapinarof Cream 1% To VTAMA ® (Tapinarof Cream 1%) In the Treatment of Plaque Psoriasis

Conditions

Plaque Type Psorisis Dermatologic Agents Skin Diseases Plaque Psoriasis Tapinarof Adult Phase 3 Topical Double-Blind Safety Efficacy Skin Diseases, Papulosquamous

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site, Clinical Study to Evaluate the Therapeutic Equivalence of Tapinarof Cream 1% (Teva Pharmaceuticals, Inc.) With VTAMA® Tapinarof (Tapinarof) Cream 1% (Dermavant Sciences, Inc.) in Adult Patients With Plaque Psoriasis

Quick Facts

Study Start:2024-12-17

Study Completion:2025-11-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06742957

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Signed ICF indicating that the patient understands the purpose of, and procedures required 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 the informed consent. 3. Patients with clinical diagnosis of chronic plaque psoriasis and stable disease for at 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 lactating at the time of screening/baseline visit as documented by a negative urine pregnancy test with a sensitivity to at least 25 mIU/ml hCG: 7. Female patients of childbearing potential must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug. 1. For the purposes of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, medroxyprogesterone acetate (ex. Depo-Provera®) with stabilized use for at least 3 months, vaginal contraceptive (ex. etonogestrel/ethinyl estradiol vaginal ring (ex. NuvaRing®), contraceptive implant with etonogestrel or equivalent, double barrier methods, (e.g. condom and spermicide), intrauterine device (IUD), true abstinence (if in line with patient's lifestyle). 2. Patients on hormonal contraception must be stabilized on the same type for at least three months prior to enrollment in the study and must not change the method during the study. A sterile sexual partner is not considered an adequate form of birth control. 3. If a patient who was abstinent becomes sexually active during the study, a second acceptable method of birth control should be used and documented. 8. Willing and able to adhere to the lifestyle restrictions specified in this protocol. 9. 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 of the investigative product. 10. Patients must be willing to refrain from using all other topical plaque psoriasis products during the 12-week treatment period, other than the investigational product.	1. Known allergies, hypersensitivity, or intolerance to any of the ingredients of study treatment interventions, or components/ excipients thereof (refer to the prescribing information of VTAMA®), or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study. 2. Current diagnosis of unstable forms of psoriasis (other than plaque variant) in the treatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis. 3. Patients with other inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis, and or any others in the opinion of the Investigator). 4. Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, 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 artificial sources of UV radiation (eg, phototherapy, tanning booths, or therapeutic sunbathing), laser therapy, tattoos removal, skin wraps or exfoliant techniques or Fraxel within 4 weeks prior to the baseline visit and/or plans to have such exposures 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 baseline evaluation. 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 1 month 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 10. Received an investigational intervention within 30 days or 5 half-lives prior to the first dose of study intervention, whichever is longer. 11. Documented medical history of uncontrolled, clinically significant intercurrent medical condition(s) (i.e., chronic infectious disease, system disorder, organ disorder, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, renal disease, severe psychiatric condition, etc.) for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. 12. Employees of the Investigator or research center or their immediate family members. 13. Females who are pregnant, breast feeding, or who wish to become pregnant during the study period. 14. Patients who have received chemotherapy or radiation therapy and/or anti-neoplastic agents within 3 months prior to screening/baseline. 15. Patients who are unable or unwilling to give informed consent. 16. Patients, who in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol. 17. 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 and barbiturates) within one year prior to screening. 18. Patients who have been previously enrolled in this study.

Inclusion Criteria

Exclusion Criteria

1. Signed ICF indicating that the patient understands the purpose of, and procedures required 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 the informed consent.
3. Patients with clinical diagnosis of chronic plaque psoriasis and stable disease for at 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 lactating at the time of screening/baseline visit as documented by a negative urine pregnancy test with a sensitivity to at least 25 mIU/ml hCG:
7. Female patients of childbearing potential must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.
1. For the purposes of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, medroxyprogesterone acetate (ex. Depo-Provera®) with stabilized use for at least 3 months, vaginal contraceptive (ex. etonogestrel/ethinyl estradiol vaginal ring (ex. NuvaRing®), contraceptive implant with etonogestrel or equivalent, double barrier methods, (e.g. condom and spermicide), intrauterine device (IUD), true abstinence (if in line with patient's lifestyle).
2. Patients on hormonal contraception must be stabilized on the same type for at least three months prior to enrollment in the study and must not change the method during the study. A sterile sexual partner is not considered an adequate form of birth control.
3. If a patient who was abstinent becomes sexually active during the study, a second acceptable method of birth control should be used and documented.
8. Willing and able to adhere to the lifestyle restrictions specified in this protocol.
9. 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 of the investigative product.
10. Patients must be willing to refrain from using all other topical plaque psoriasis products during the 12-week treatment period, other than the investigational product.

1. Known allergies, hypersensitivity, or intolerance to any of the ingredients of study treatment interventions, or components/ excipients thereof (refer to the prescribing information of VTAMA®), or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
2. Current diagnosis of unstable forms of psoriasis (other than plaque variant) in the treatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis.
3. Patients with other inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis, and or any others in the opinion of the Investigator).
4. Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, 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 artificial sources of UV radiation (eg, phototherapy, tanning booths, or therapeutic sunbathing), laser therapy, tattoos removal, skin wraps or exfoliant techniques or Fraxel within 4 weeks prior to the baseline visit and/or plans to have such exposures 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 baseline evaluation.
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 1 month 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
10. Received an investigational intervention within 30 days or 5 half-lives prior to the first dose of study intervention, whichever is longer.
11. Documented medical history of uncontrolled, clinically significant intercurrent medical condition(s) (i.e., chronic infectious disease, system disorder, organ disorder, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, renal disease, severe psychiatric condition, etc.) for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
12. Employees of the Investigator or research center or their immediate family members.
13. Females who are pregnant, breast feeding, or who wish to become pregnant during the study period.
14. Patients who have received chemotherapy or radiation therapy and/or anti-neoplastic agents within 3 months prior to screening/baseline.
15. Patients who are unable or unwilling to give informed consent.
16. Patients, who in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol.
17. 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 and barbiturates) within one year prior to screening.
18. Patients who have been previously enrolled in this study.

Contacts and Locations

Study Locations (Sites)

Site 12107

Scottsdale, Arizona, 85260

United States

Site 12101

Bryant, Arkansas, 72022

United States

Site 12110

Dublin, California, 94568

United States

Site 12112

Dublin, California, 94568

United States

Site 12102

Fremont, California, 94538

United States

Site 12119

Huntington Beach, California, 92647

United States

Site 12120

Northridge, California, 91325

United States

Site 12111

Pomona, California, 91767

United States

Site 12122

Greenwich, Connecticut, 06831

United States

Site 12115

Fort Lauderdale, Florida, 33308

United States

Site 12104

Miami, Florida, 33144

United States

Site 12116

Miami, Florida, 33146

United States

Site 12113

Miami, Florida, 33175

United States

Site 12114

Miramar, Florida, 33027

United States

Site 12108

Chicago, Illinois, 60614

United States

Site 12121

Rolling Meadows, Illinois, 60008

United States

Site 12106

Clarksville, Indiana, 47129

United States

Site 12123

Merrillville, Indiana, 46410

United States

Site 12105

Louisville, Kentucky, 40241

United States

Site 12109

Las Vegas, Nevada, 89121

United States

12127

Woodbury, New York, 11797

United States

Site 12126

Portland, Oregon, 97210

United States

Site 12125

Upper Saint Clair, Pennsylvania, 15241

United States

Site 12103

College Station, Texas, 77845

United States

Site 12118

El Paso, Texas, 79925

United States

Site 12117

Houston, Texas, 77070

United States

Collaborators and Investigators

Sponsor: Teva Pharmaceuticals USA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-17

Study Completion Date2025-11-12

Study Record Updates

Study Start Date2024-12-17

Study Completion Date2025-11-12

Terms related to this study

Keywords Provided by Researchers

Dermatologic Agents
Skin Diseases
Plaque Psoriasis
Tapinarof
Adult
Phase 3
Topical
Double-Blind
Safety
Efficacy
Skin Diseases, Papulosquamous

Additional Relevant MeSH Terms

Plaque Type Psorisis