Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)

NCT ID: NCT04053387

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 763 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-13
• Study Completion Date: 2021-04-06

Brief Summary

This is a long-term, open-label, multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in adults with plaque psoriasis. Subjects in this study completed treatment in 1 of 2 Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). This study will consist of up to 40 weeks of treatment and a 4-week safety follow-up period.

Detailed Description

At the completion of the Week-12 visit of the pivotal study (Baseline [Day 1] in this study), all eligible subjects will be offered enrollment in the long-term extension study. Study visits during the treatment period for all subjects will occur every 4 weeks (± 3 days). The total duration of study participation will be approximately 44 weeks.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tapinarof (DMVT-505) Cream Group

Subjects who completed 1 of the phase 3 studies evaluating the safety and efficacy of tapinarof had the option to enter this extension study.

Subjects entering with a PGA ≥ 1 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (remittive response). If/when disease worsening occurred, as evidenced by a PGA ≥ 2, treatment was re initiated and continued until a PGA = 0 was achieved.

Subjects entering with a PGA = 0 had treatment discontinued and were monitored for duration of remittive response. If/when disease worsening occurred, as evidenced by a PGA ≥ 2, treatment was re initiated and continued until a PGA = 0 was achieved.

This treatment and re treatment pattern of use was continued until the end of the study

Group Type: EXPERIMENTAL

tapinarof cream, 1%

Intervention Type: DRUG

Intermittent use of Tapinarof cream, 1%, applied once daily according to PGA score

Interventions

tapinarof cream, 1%

Intermittent use of Tapinarof cream, 1%, applied once daily according to PGA score

Intervention Type: DRUG

Other Intervention Names

DMVT-505

Eligibility Criteria

Inclusion Criteria

1. Completed the 12-week treatment period in 1 of the 2 parent studies (Study DMVT-505-3001 or Study DMVT-505-3002);

2. Male and female subjects

3. Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance while on the study, and for at least 4 weeks after the last exposure to study treatment

4. Capable of giving written informed consent

Exclusion Criteria

1. Used a prohibited concomitant product or procedure to treat psoriasis during parent study

2. Had a serious adverse event (SAE) that was potentially related to treatment or experienced an adverse event (AE) that led to permanent discontinuation of treatment in the parent study

3. 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 completion of the study

4. Known hypersensitivity to tapinarof

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IQVIA Biotech

INDUSTRY

Sponsor Role: collaborator

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victoria Butners

Role: STUDY_DIRECTOR

Dermavant Sciences GmbH

Locations

Dermavant Investigative Site

Birmingham, Alabama, United States

Dermavant Investigative Site

Phoenix, Arizona, United States

Dermavant Investigative Site

Bryant, Arkansas, United States

Dermavant Investigative Site

Fort Smith, Arkansas, United States

Dermavant Investigative Site

Fountain Valley, California, United States

Dermavant Investigative Site

Fremont, California, United States

Dermavant Investigative Site

Fresno, California, United States

Dermavant Investigative Site

Los Angeles, California, United States

Dermavant Investigative Site

Los Angeles, California, United States

Dermavant Investigative Site

Northridge, California, United States

Dermavant Investigative Site

Oceanside, California, United States

Dermavant Investigative Site

San Diego, California, United States

Dermavant Investigative Site

Santa Ana, California, United States

Dermavant Investigative Site

Santa Monica, California, United States

Dermavant Investigative Site

Denver, Colorado, United States

Dermavant Investigative Site

Cromwell, Connecticut, United States

Dermavant Investigative Site

Boca Raton, Florida, United States

Dermavant Investigative Site

Boynton Beach, Florida, United States

Dermavant Investigative Site

Hialeah, Florida, United States

Dermavant Investigative Site

Margate, Florida, United States

Dermavant Investigative Site

Miami, Florida, United States

Dermavant Investigative Site

Miramar, Florida, United States

Dermavant Investigative Site

Boise, Idaho, United States

Dermavant Investigative Site

Rolling Meadows, Illinois, United States

Dermavant Investigative Site

Evansville, Indiana, United States

Dermavant Investigative Site

Indianapolis, Indiana, United States

Dermavant Investigative Site

New Albany, Indiana, United States

Dermavant Investigative Site

Plainfield, Indiana, United States

Dermavant Investigative Site

Overland Park, Kansas, United States

Dermavant Investigative Site

Louisville, Kentucky, United States

Dermavant Investigative Site

Owensboro, Kentucky, United States

Dermavant Investigative Site

Baton Rouge, Louisiana, United States

Dermavant Investigative Site

New Orleans, Louisiana, United States

Dermavant Investigative Site

Rockville, Maryland, United States

Dermavant Investigative Site

Boston, Massachusetts, United States

Dermavant Investigative Site

Bay City, Michigan, United States

Dermavant Investigative Site

Clarkston, Michigan, United States

Dermavant Clinical Site

Detroit, Michigan, United States

Dermavant Investigational Site

Detroit, Michigan, United States

Dermavant Investigative Site

Fort Gratiot, Michigan, United States

Dermavant Investigative Site

Warren, Michigan, United States

Dermavant Investigative Site

Fridley, Minnesota, United States

Dermavant Investigative Site

Saint Joseph, Missouri, United States

Dermavant Investigative Site

Omaha, Nebraska, United States

Dermavant Clinical Site

Las Vegas, Nevada, United States

Dermavant Investigative Site

Las Vegas, Nevada, United States

Dermavant Investigative Site

East Windsor, New Jersey, United States

Dermavant Investigative Site

Hackensack, New Jersey, United States

Dermavant Investigative Site

Verona, New Jersey, United States

Dermavant Clinical Site

Brooklyn, New York, United States

Dermavant Investigative Site

Kew Gardens, New York, United States

Dermavant Investigative Site

New York, New York, United States

Dermavant Investigative Site

Rochester, New York, United States

Dermavant Investigative Site

Stony Brook, New York, United States

Dermavant Clinical Site

Watertown, New York, United States

Dermavant Investigative Site

Cary, North Carolina, United States

Dermavant Investigative Site

High Point, North Carolina, United States

Dermavant Investigative Site

Wilmington, North Carolina, United States

Dermavant Investigative Site

Winston-Salem, North Carolina, United States

Dermavant Investigative Site

Beachwood, Ohio, United States

Dermavant Investigative Site

Bexley, Ohio, United States

Dermavant Investigative Site

Norman, Oklahoma, United States

Dermavant Investigate Site

Norman, Oklahoma, United States

Dermavant Investigative Site

Norman, Oklahoma, United States

Dermavant Clinical Site

Gresham, Oregon, United States

Dermavant Investigative Site

Portland, Oregon, United States

Dermavant Investigative Site

Portland, Oregon, United States

Dermavant Investigative Site

Pittsburgh, Pennsylvania, United States

Dermavant Investigative Site

Johnston, Rhode Island, United States

Dermavant Investigative Site

Charleston, South Carolina, United States

Dermavant Investigative Site

Nashville, Tennessee, United States

Dermavant Investigative Site

Arlington, Texas, United States

Dermavant Clinical Site

Bellaire, Texas, United States

Dermavant Investigative Site

College Station, Texas, United States

Dermavant Investigative Site

Dripping Springs, Texas, United States

Dermavant Investigative Site

Houston, Texas, United States

Dermavant Clinical Site

Houston, Texas, United States

Dermavant Investigative Site

Pflugerville, Texas, United States

Dermavant Investigative Site

Plano, Texas, United States

Dermavant Investigative Site

San Antonio, Texas, United States

Dermavant Investigative Site

San Antonio, Texas, United States

Dermavant Investigative Site

Webster, Texas, United States

Dermavant Investigative Site

West Jordan, Utah, United States

Dermavant Investigative Site

Norfolk, Virginia, United States

Dermavant Investigative Site

Spokane, Washington, United States

Dermavant Investigative Site

Edmonton, Alberta, Canada

Dermavant Investigative Site

Surrey, Bristish Columbia, Canada

Dermavant Investigative Site

Surrey, British Columbia, Canada

Dermavant Investigative Site

Ajax, Ontario, Canada

Dermavant Clinical Site

Burlington, Ontario, Canada

Dermavant Investigative Site

Cobourg, Ontario, Canada

Dermavant Investigative Site

Etobicoke, Ontario, Canada

Dermavant Investigative Site

Hamilton, Ontario, Canada

Dermavant Clinical Site

Hamilton, Ontario, Canada

Dermavant Investigative Site

Markham, Ontario, Canada

Dermavant Clinical Site

Markham, Ontario, Canada

Dermavant Investigative Site

North Bay, Ontario, Canada

Dermavant Investigative Site

Oakville, Ontario, Canada

Dermavant Investigative Site

Ottawa, Ontario, Canada

Dermavant Investigative Site

Richmond Hill, Ontario, Canada

Dermavant Investigative Site

Toronto, Ontario, Canada

Dermavant Investigative Site

Waterloo, Ontario, Canada

Dermavant Investigative Site

Windsor, Ontario, Canada

Dermavant Investigative Site

Montreal, Quebec, Canada

Countries

United States; Canada

References

Gold LS, Bruno MJ, Lewitt GM, Hebert AA. Characteristics and management of follicular events and contact dermatitis in patients using tapinarof cream for the treatment of atopic dermatitis or plaque psoriasis. J Dermatolog Treat. 2025 Dec;36(1):2517388. doi: 10.1080/09546634.2025.2517388. Epub 2025 Jul 2.

Reference Type: DERIVED

PMID: 40600584 (View on PubMed)

Desai SR, Stein Gold L, Cameron MC, Golant A, Lewitt GM, Bruno MJ, Martin G, Brown PM, Rubenstein DS, Butners V, Tallman AM. Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Case Photography of Clinical Outcomes from Three Phase 3 Trials. Dermatol Ther (Heidelb). 2023 Oct;13(10):2443-2460. doi: 10.1007/s13555-023-01008-9. Epub 2023 Sep 11.

Reference Type: DERIVED

PMID: 37697121 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DMVT-505-3003

Identifier Type: -

Identifier Source: org_study_id