Clinical trial NCT04053387: Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)
Official title: A Long-Term, Open-Label, Extension Study to Evaluate the Safety and Efficacy of Tapinarof Cream, 1% for the Treatment of Plaque Psoriasis in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: Tapinarof
plaque psoriasis,
adult
phase 3
topical
open-label
efficacy
safety
psoriasis
long-term
therapeutic aryl hydrocarbon receptor modulating agent
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: IQVIA Biotech
First posted: 2019-08-12
Enrollment: 763
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects in this study completed treatment with tapinarof or vehicle in 1 of 2 parent Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). The study will consist of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Subjects With Adverse Events and Serious Adverse Events
timeFrame: Baseline to 44 weeks
measure: Frequency of Adverse Events and Serious Adverse Events
timeFrame: Baseline to 44 weeks
measure: Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs
timeFrame: Baseline to 40 weeks
measure: Remittive Effect of Treatment Success in Pivotal: Median Time to First Worsening (PGA ≥ 2) While Off Therapy for Subjects Who Entered LTE PGA = 0 (Clear)
timeFrame: Baseline to 44 weeks
measure: Complete Disease Clearance During LTE: Number of Subjects Achieving Disease Clearance PGA =0 (Clear) While on Therapy for Subjects Entered LTE PGA ≥ 1 (Almost Clear)
timeFrame: Baseline to 44 weeks
measure: Response During LTE: Number of Subjects Achieving PGA =0 or 1 (Clear or Almost Clear) While on Therapy for Subjects Who Entered LTE With PGA ≥ 2 (Mild)
timeFrame: Baseline to 44 weeks
measure: Remittive Effect of Treatment Success: Number of Subjects Experiencing Worsening (PGA ≥ 2) While Off Therapy for Subjects Who Entered LTE With a PGA = 0 (Clear)
timeFrame: Baseline to 44 weeks
measure: Change From Baseline in %BSA Affected
timeFrame: Baseline to 40 weeks
measure: Percent Change From Baseline in %BSA Affected
timeFrame: Baseline to 40 weeks
measure: Mean Duration (Days) of Treatment Course
timeFrame: Baseline to 40 weeks
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
timeFrame: Baseline to 40 weeks
measure: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
timeFrame: Baseline to 40 weeks
measure: Change From Baseline in Disease Impact on Daily Activities, as Measured by the Dermatology Life Quality Index (DLQI)
timeFrame: Baseline to 40 weeks
measure: Percent Change From Baseline in Disease Impact on Daily Activities, as Measured by the Dermatology Life Quality Index (DLQI)
timeFrame: Baseline to 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Dermavant Investigative Site
state: Alabama
city: Phoenix
country: United States
facility: Dermavant Investigative Site
state: Arizona
city: Bryant
country: United States
facility: Dermavant Investigative Site
state: Arkansas
city: Fort Smith
country: United States
facility: Dermavant Investigative Site
state: Arkansas
city: Fountain Valley
country: United States
facility: Dermavant Investigative Site
state: California
city: Fremont
country: United States
facility: Dermavant Investigative Site
state: California
city: Fresno
country: United States
facility: Dermavant Investigative Site
state: California
city: Los Angeles
country: United States
facility: Dermavant Investigative Site
state: California
city: Los Angeles
country: United States
facility: Dermavant Investigative Site
state: California
city: Northridge
country: United States
facility: Dermavant Investigative Site
state: California
city: Oceanside
country: United States
facility: Dermavant Investigative Site
state: California
city: San Diego
country: United States
facility: Dermavant Investigative Site
state: California
city: Santa Ana
country: United States
facility: Dermavant Investigative Site
state: California
city: Santa Monica
country: United States
facility: Dermavant Investigative Site
state: California
city: Denver
country: United States
facility: Dermavant Investigative Site
state: Colorado
city: Cromwell
country: United States
facility: Dermavant Investigative Site
state: Connecticut
city: Boca Raton
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Boynton Beach
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Hialeah
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Margate
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Miami
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Miramar
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Boise
country: United States
facility: Dermavant Investigative Site
state: Idaho
city: Rolling Meadows
country: United States
facility: Dermavant Investigative Site
state: Illinois
city: Evansville
country: United States
facility: Dermavant Investigative Site
state: Indiana
city: Indianapolis
country: United States
facility: Dermavant Investigative Site
state: Indiana
city: New Albany
country: United States
facility: Dermavant Investigative Site
state: Indiana
city: Plainfield
country: United States
facility: Dermavant Investigative Site
state: Indiana
city: Overland Park
country: United States
facility: Dermavant Investigative Site
state: Kansas
city: Louisville
country: United States
facility: Dermavant Investigative Site
state: Kentucky
city: Owensboro
country: United States
facility: Dermavant Investigative Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Dermavant Investigative Site
state: Louisiana
city: New Orleans
country: United States
facility: Dermavant Investigative Site
state: Louisiana
city: Rockville
country: United States
facility: Dermavant Investigative Site
state: Maryland
city: Boston
country: United States
facility: Dermavant Investigative Site
state: Massachusetts
city: Bay City
country: United States
facility: Dermavant Investigative Site
state: Michigan
city: Clarkston
country: United States
facility: Dermavant Investigative Site
state: Michigan
city: Detroit
country: United States
facility: Dermavant Clinical Site
state: Michigan
city: Detroit
country: United States
facility: Dermavant Investigational Site
state: Michigan
city: Fort Gratiot
country: United States
facility: Dermavant Investigative Site
state: Michigan
city: Warren
country: United States
facility: Dermavant Investigative Site
state: Michigan
city: Fridley
country: United States
facility: Dermavant Investigative Site
state: Minnesota
city: Saint Joseph
country: United States
facility: Dermavant Investigative Site
state: Missouri
city: Omaha
country: United States
facility: Dermavant Investigative Site
state: Nebraska
city: Las Vegas
country: United States
facility: Dermavant Clinical Site
state: Nevada
city: Las Vegas
country: United States
facility: Dermavant Investigative Site
state: Nevada
city: East Windsor
country: United States
facility: Dermavant Investigative Site
state: New Jersey
city: Hackensack
country: United States
facility: Dermavant Investigative Site
state: New Jersey
city: Verona
country: United States
facility: Dermavant Investigative Site
state: New Jersey
city: Brooklyn
country: United States
facility: Dermavant Clinical Site
state: New York
city: Kew Gardens
country: United States
facility: Dermavant Investigative Site
state: New York
city: New York
country: United States
facility: Dermavant Investigative Site
state: New York
city: Rochester
country: United States
facility: Dermavant Investigative Site
state: New York
city: Stony Brook
country: United States
facility: Dermavant Investigative Site
state: New York
city: Watertown
country: United States
facility: Dermavant Clinical Site
state: New York
city: Cary
country: United States
facility: Dermavant Investigative Site
state: North Carolina
city: High Point
country: United States
facility: Dermavant Investigative Site
state: North Carolina
city: Wilmington
country: United States
facility: Dermavant Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Dermavant Investigative Site
state: North Carolina
city: Beachwood
country: United States
facility: Dermavant Investigative Site
state: Ohio
city: Bexley
country: United States
facility: Dermavant Investigative Site
state: Ohio
city: Norman
country: United States
facility: Dermavant Investigative Site
state: Oklahoma
city: Norman
country: United States
facility: Dermavant Investigate Site
state: Oklahoma
city: Norman
country: United States
facility: Dermavant Investigative Site
state: Oklahoma
city: Gresham
country: United States
facility: Dermavant Clinical Site
state: Oregon
city: Portland
country: United States
facility: Dermavant Investigative Site
state: Oregon
city: Portland
country: United States
facility: Dermavant Investigative Site
state: Oregon
city: Pittsburgh
country: United States
facility: Dermavant Investigative Site
state: Pennsylvania
city: Johnston
country: United States
facility: Dermavant Investigative Site
state: Rhode Island
city: Charleston
country: United States
facility: Dermavant Investigative Site
state: South Carolina
city: Nashville
country: United States
facility: Dermavant Investigative Site
state: Tennessee
city: Arlington
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Bellaire
country: United States
facility: Dermavant Clinical Site
state: Texas
city: College Station
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Dripping Springs
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Houston
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Houston
country: United States
facility: Dermavant Clinical Site
state: Texas
city: Pflugerville
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Plano
country: United States
facility: Dermavant Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Dermavant Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Webster
country: United States
facility: Dermavant Investigative Site
state: Texas
city: West Jordan
country: United States
facility: Dermavant Investigative Site
state: Utah
city: Norfolk
country: United States
facility: Dermavant Investigative Site
state: Virginia
city: Spokane
country: United States
facility: Dermavant Investigative Site
state: Washington
city: Edmonton
country: Canada
facility: Dermavant Investigative Site
state: Alberta
city: Surrey
country: Canada
facility: Dermavant Investigative Site
state: Bristish Columbia
city: Surrey
country: Canada
facility: Dermavant Investigative Site
state: British Columbia
city: Ajax
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Burlington
country: Canada
facility: Dermavant Clinical Site
state: Ontario
city: Cobourg
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Etobicoke
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Hamilton
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Hamilton
country: Canada
facility: Dermavant Clinical Site
state: Ontario
city: Markham
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Markham
country: Canada
facility: Dermavant Clinical Site
state: Ontario
city: North Bay
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Oakville
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Richmond Hill
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Waterloo
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Windsor
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Montréal
country: Canada
facility: Dermavant Investigative Site
state: Quebec
Study officials:
affiliation: Dermavant Sciences GmbH
name: Victoria Butners
role: STUDY_DIRECTOR
References: