Back to results

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

Primary Purpose

Plaque Psoriasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

tapinarof cream, 1%

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring Tapinarof, plaque psoriasis,, adult, phase 3, topical, open-label, efficacy, safety, psoriasis, long-term, therapeutic aryl hydrocarbon receptor modulating agent

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Completed the 12-week treatment period in 1 of the 2 parent studies (Study DMVT-505-3001 or Study DMVT-505-3002);
Male and female subjects
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
Capable of giving written informed consent

Exclusion Criteria:

Used a prohibited concomitant product or procedure to treat psoriasis during parent study
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
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
Known hypersensitivity to tapinarof

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tapinarof (DMVT-505) Cream Group

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Subjects With Adverse Events and Serious Adverse Events

All AEs reported in this extension study were considered as TEAEs except for those AEs ongoing at the end of the pivotal Phase 3 studies but resolved prior to the Visit 1 date for this extension study. All SAEs were deemed unrelated to treatment with tapinarof cream, 1%.

Frequency of Adverse Events and Serious Adverse Events

All AEs reported in this extension study were considered as TEAEs except for those AEs ongoing at the end of the pivotal Phase 3 studies but resolved prior to the Visit 1 date for this extension study. Subjects could have reported more than one TEAE. All SAEs were deemed unrelated to treatment with tapinarof cream, 1%.

Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs

The mean chemistry and hematology parameters were assessed for changes and trends over the course of the study. Shifts from Baseline in chemistry and hematology parameters for individual subjects were assessed for clinical relevance. The number of subjects with clinically significant changes from baseline in laboratory values was assessed for clinical relevance.

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)

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 = 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 outcome measure assesses the median time for subjects entering with a PGA = 0 to first worsening (PGA ≥ 2) while off therapy during this extension study. The PGA is an assessment of a subject's psoriasis using a static 5-point scale to grade lesions on the clinical characteristics of erythema, scaling, and plaque thickness/elevation. The PGA ranges from 0 to 4, where 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, and 4 = severe.

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)

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 continued treatment with tapinarof until they achieved a PGA = 0, at which time treatment was discontinued and subjects were monitored for 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 outcome measure assesses the number of subjects who entered the extension study with a PGA ≥ 1 and achieved complete disease clearance (PGA=0) while on therapy during this extension study. The PGA is an assessment of a subject's psoriasis using a static 5-point scale to grade lesions on the clinical characteristics of erythema, scaling, and plaque thickness/elevation. The PGA ranges from 0 to 4, where 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, and 4 = severe. Higher PGA scores represent more severe disease.

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)

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 continued treatment with tapinarof until they achieved a PGA = 0, at which time treatment was discontinued and subjects were monitored for 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 outcome measure assesses the number of these subjects who entered the study with a PGA≥ 2 and achieved a PGA of 0 or 1 (clear or almost clear) while on therapy during this extension study. The PGA is an assessment of a subject's psoriasis using a static 5-point scale to grade lesions on the clinical characteristics of erythema, scaling, and plaque thickness/elevation. The PGA ranges from 0 to 4, where 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, and 4 = severe. Higher PGA scores represent more severe disease.

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)

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 = 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. This outcome measure assesses the number of these subjects entering the study with a PGA= 0 who experienced worsening (PGA ≥ 2) while off therapy at least once during this extension study. The PGA is an assessment of a subject's psoriasis using a static 5-point scale to grade lesions on the clinical characteristics of erythema, scaling, and plaque thickness/elevation. The PGA ranges from 0 to 4, where 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, and 4 = severe.

Change From Baseline in %BSA Affected

Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses the change from baseline in %BSA affected in all subjects, including those on and those off therapy. BSA affected was estimated by the handprint method, where the full palmar hand of the subject represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints (hp) with percentage [Head and neck = 10% (10 hp), upper extremities = 20% (20 hp), Trunk (including axillae and groin) = 30% (30 hp), lower extremities (including buttocks) = 40% (40 hp)]. The total %BSA involved was estimated = % involvement

Percent Change From Baseline in %BSA Affected

Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses the % change from baseline in %BSA affected in all subjects, including those on and those off therapy. BSA affected was estimated by the handprint method, where the full palmar hand of the subject represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints (hp) with percentage [Head and neck = 10% (10 hp), upper extremities = 20% (20 hp), Trunk (including axillae and groin) = 30% (30 hp), lower extremities (including buttocks) = 40% (40 hp)]. The total %BSA involved was estimated = % involvement

Mean Duration (Days) of Treatment Course

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 continued tapinarof until they achieved a PGA = 0, at which time treatment was discontinued. If/when disease worsening occurred, as evidenced by a PGA ≥ 2, treatment was re-initiated and continued until a PGA = 0 was achieved. Mean duration (days) of treatment episode = time (days) from date of each PGA ≥ 2 (or PGA ≥ 1 for the first episode) to 1 day before each subsequent PGA = 0. The PGA is an assessment of a subject's psoriasis using a static 5-point scale to grade lesions on the clinical characteristics of erythema, scaling, and plaque thickness/elevation. The PGA ranges from 0 to 4, where 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, and 4 = severe. Higher PGA scores represent more severe disease.

Change From Baseline in Psoriasis Area and Severity Index (PASI) Score

Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses the change from baseline in PASI score in all subjects, including those on and those off therapy. The PASI scoring system combines the assessment of lesion severity and extent of affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, and legs). Each area is assessed for 3 signs: erythema (redness), induration (plaque thickness), and scale. The severity of each sign in each body area is assessed and scored independently using a 5-point scale, where 0=none, 1=slight, 2=mild, 3=moderate, 4=severe. Each area is also assessed for percent of skin involved: 0 = (0%), 1 = (1-<10%), 2 = (10-<30%), 3 = (30-<50%), 4 = (50 -<70%), 5 = (70-<90%), 6 = (90-100%). Overall PASI = the sum of (individual scores x by a weighted factor for each body region).

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score

Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses the % change from baseline in PASI score in all subjects, including those on and those off therapy. The PASI scoring system combines the assessment of lesion severity and extent of affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, and legs). Each area is assessed for 3 signs: erythema (redness), induration (plaque thickness), and scale. The severity of each sign in each body area is assessed and scored independently using a 5-point scale, where 0=none, 1=slight, 2=mild, 3=moderate, 4=severe. Each area is also assessed for percent of skin involved: 0 = (0%), 1 = (1-<10%), 2 = (10-<30%), 3 = (30-<50%), 4 = (50 -<70%), 5 = (70-<90%), 6 = (90-100%). Overall PASI = the sum of (individual scores x by a weighted factor for each body region).

Change From Baseline in Disease Impact on Daily Activities, as Measured by the Dermatology Life Quality Index (DLQI)

Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses change from baseline in disease impact on daily activities, as measured by the DLQI, in all subjects including those on and those off therapy. The DLQI is a 10-item PRO measure that assesses the extent to which the skin condition has affected the subject's quality of life over the past week, including 6 domains (daily activities, personal relationships, symptoms and feelings, leisure, work/school, and treatment). The total score (0-30) is the sum of 10 questions with each ranging from 0 to 3. The scoring of each question is as follows: Very much= 3, A lot=2, A little = 1, Not at all = 0, Not relevant = 0, Question unanswered = 0. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.

Percent Change From Baseline in Disease Impact on Daily Activities, as Measured by the Dermatology Life Quality Index (DLQI)

Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses % change from baseline in disease impact on daily activities, as measured by the DLQI, in all subjects including those on and those off therapy. The DLQI is a 10-item PRO measure that assesses the extent to which the skin condition has affected the subject's quality of life over the past week, including 6 domains (daily activities, personal relationships, symptoms and feelings, leisure, work/school, and treatment). The total score (0-30) is the sum of 10 questions with each ranging from 0 to 3. The scoring of each question is as follows: Very much= 3, A lot=2, A little = 1, Not at all = 0, Not relevant = 0, Question unanswered = 0.

Secondary Outcome Measures

Full Information

NCT ID

NCT04053387

First Posted

July 23, 2019

Last Updated

September 16, 2022

Sponsor

Dermavant Sciences GmbH

Collaborators

IQVIA Biotech

1. Study Identification

Unique Protocol Identification Number

NCT04053387

Brief Title

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

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

August 13, 2019 (Actual)

Primary Completion Date

April 6, 2021 (Actual)

Study Completion Date

April 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dermavant Sciences GmbH

Collaborators

IQVIA Biotech

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis

Keywords

Tapinarof, plaque psoriasis,, adult, phase 3, topical, open-label, efficacy, safety, psoriasis, long-term, therapeutic aryl hydrocarbon receptor modulating agent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

763 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tapinarof (DMVT-505) Cream Group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

tapinarof cream, 1%

Other Intervention Name(s)

DMVT-505

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Subjects With Adverse Events and Serious Adverse Events

Description

Time Frame

Baseline to 44 weeks

Title

Frequency of Adverse Events and Serious Adverse Events

Description

All AEs reported in this extension study were considered as TEAEs except for those AEs ongoing at the end of the pivotal Phase 3 studies but resolved prior to the Visit 1 date for this extension study. Subjects could have reported more than one TEAE. All SAEs were deemed unrelated to treatment with tapinarof cream, 1%.

Time Frame

Baseline to 44 weeks

Title

Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs

Description

Time Frame

Baseline to 40 weeks

Title

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)

Description

Time Frame

Baseline to 44 weeks

Title

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)

Description

Time Frame

Baseline to 44 weeks

Title

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)

Description

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 continued treatment with tapinarof until they achieved a PGA = 0, at which time treatment was discontinued and subjects were monitored for 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 outcome measure assesses the number of these subjects who entered the study with a PGA≥ 2 and achieved a PGA of 0 or 1 (clear or almost clear) while on therapy during this extension study. The PGA is an assessment of a subject's psoriasis using a static 5-point scale to grade lesions on the clinical characteristics of erythema, scaling, and plaque thickness/elevation. The PGA ranges from 0 to 4, where 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, and 4 = severe. Higher PGA scores represent more severe disease.

Time Frame

Baseline to 44 weeks

Title

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)

Description

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 = 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. This outcome measure assesses the number of these subjects entering the study with a PGA= 0 who experienced worsening (PGA ≥ 2) while off therapy at least once during this extension study. The PGA is an assessment of a subject's psoriasis using a static 5-point scale to grade lesions on the clinical characteristics of erythema, scaling, and plaque thickness/elevation. The PGA ranges from 0 to 4, where 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, and 4 = severe.

Time Frame

Baseline to 44 weeks

Title

Change From Baseline in %BSA Affected

Description

Time Frame

Baseline to 40 weeks

Title

Percent Change From Baseline in %BSA Affected

Description

Time Frame

Baseline to 40 weeks

Title

Mean Duration (Days) of Treatment Course

Description

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 continued tapinarof until they achieved a PGA = 0, at which time treatment was discontinued. If/when disease worsening occurred, as evidenced by a PGA ≥ 2, treatment was re-initiated and continued until a PGA = 0 was achieved. Mean duration (days) of treatment episode = time (days) from date of each PGA ≥ 2 (or PGA ≥ 1 for the first episode) to 1 day before each subsequent PGA = 0. The PGA is an assessment of a subject's psoriasis using a static 5-point scale to grade lesions on the clinical characteristics of erythema, scaling, and plaque thickness/elevation. The PGA ranges from 0 to 4, where 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, and 4 = severe. Higher PGA scores represent more severe disease.

Time Frame

Baseline to 40 weeks

Title

Change From Baseline in Psoriasis Area and Severity Index (PASI) Score

Description

Time Frame

Baseline to 40 weeks

Title

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score

Description

Time Frame

Baseline to 40 weeks

Title

Change From Baseline in Disease Impact on Daily Activities, as Measured by the Dermatology Life Quality Index (DLQI)

Description

Time Frame

Baseline to 40 weeks

Title

Percent Change From Baseline in Disease Impact on Daily Activities, as Measured by the Dermatology Life Quality Index (DLQI)

Description

Time Frame

Baseline to 40 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Completed the 12-week treatment period in 1 of the 2 parent studies (Study DMVT-505-3001 or Study DMVT-505-3002); Male and female subjects 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 Capable of giving written informed consent Exclusion Criteria: Used a prohibited concomitant product or procedure to treat psoriasis during parent study 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 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 Known hypersensitivity to tapinarof

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Victoria Butners

Organizational Affiliation

Dermavant Sciences GmbH

Official's Role

Study Director

Facility Information:

Facility Name

Dermavant Investigative Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Dermavant Investigative Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

Dermavant Investigative Site

City

Bryant

State/Province

Arkansas

ZIP/Postal Code

72022

Country

United States

Facility Name

Dermavant Investigative Site

City

Fort Smith

State/Province

Arkansas

ZIP/Postal Code

72916

Country

United States

Facility Name

Dermavant Investigative Site

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Dermavant Investigative Site

City

Fremont

State/Province

California

ZIP/Postal Code

94538

Country

United States

Facility Name

Dermavant Investigative Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Dermavant Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Dermavant Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

Dermavant Investigative Site

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

Facility Name

Dermavant Investigative Site

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Dermavant Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Dermavant Investigative Site

City

Santa Ana

State/Province

California

ZIP/Postal Code

92701

Country

United States

Facility Name

Dermavant Investigative Site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Dermavant Investigative Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80210

Country

United States

Facility Name

Dermavant Investigative Site

City

Cromwell

State/Province

Connecticut

ZIP/Postal Code

06416

Country

United States

Facility Name

Dermavant Investigative Site

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33431

Country

United States

Facility Name

Dermavant Investigative Site

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33437

Country

United States

Facility Name

Dermavant Investigative Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Dermavant Investigative Site

City

Margate

State/Province

Florida

ZIP/Postal Code

33063

Country

United States

Facility Name

Dermavant Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Dermavant Investigative Site

City

Miramar

State/Province

Florida

ZIP/Postal Code

33027

Country

United States

Facility Name

Dermavant Investigative Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83713

Country

United States

Facility Name

Dermavant Investigative Site

City

Rolling Meadows

State/Province

Illinois

ZIP/Postal Code

60008

Country

United States

Facility Name

Dermavant Investigative Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Dermavant Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46250

Country

United States

Facility Name

Dermavant Investigative Site

City

New Albany

State/Province

Indiana

ZIP/Postal Code

47150

Country

United States

Facility Name

Dermavant Investigative Site

City

Plainfield

State/Province

Indiana

ZIP/Postal Code

46168

Country

United States

Facility Name

Dermavant Investigative Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66215

Country

United States

Facility Name

Dermavant Investigative Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

Facility Name

Dermavant Investigative Site

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42303

Country

United States

Facility Name

Dermavant Investigative Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

Dermavant Investigative Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70115

Country

United States

Facility Name

Dermavant Investigative Site

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Dermavant Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Dermavant Investigative Site

City

Bay City

State/Province

Michigan

ZIP/Postal Code

48706

Country

United States

Facility Name

Dermavant Investigative Site

City

Clarkston

State/Province

Michigan

ZIP/Postal Code

48346

Country

United States

Facility Name

Dermavant Clinical Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Dermavant Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Dermavant Investigative Site

City

Fort Gratiot

State/Province

Michigan

ZIP/Postal Code

48059

Country

United States

Facility Name

Dermavant Investigative Site

City

Warren

State/Province

Michigan

ZIP/Postal Code

48088

Country

United States

Facility Name

Dermavant Investigative Site

City

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Dermavant Investigative Site

City

Saint Joseph

State/Province

Missouri

ZIP/Postal Code

64506

Country

United States

Facility Name

Dermavant Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68144

Country

United States

Facility Name

Dermavant Clinical Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Dermavant Investigative Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Dermavant Investigative Site

City

East Windsor

State/Province

New Jersey

ZIP/Postal Code

08520

Country

United States

Facility Name

Dermavant Investigative Site

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Dermavant Investigative Site

City

Verona

State/Province

New Jersey

ZIP/Postal Code

07044

Country

United States

Facility Name

Dermavant Clinical Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11203

Country

United States

Facility Name

Dermavant Investigative Site

City

Kew Gardens

State/Province

New York

ZIP/Postal Code

11374

Country

United States

Facility Name

Dermavant Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Dermavant Investigative Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14623

Country

United States

Facility Name

Dermavant Investigative Site

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11790

Country

United States

Facility Name

Dermavant Clinical Site

City

Watertown

State/Province

New York

ZIP/Postal Code

13601

Country

United States

Facility Name

Dermavant Investigative Site

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

Dermavant Investigative Site

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Dermavant Investigative Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28405

Country

United States

Facility Name

Dermavant Investigative Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Dermavant Investigative Site

City

Beachwood

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Dermavant Investigative Site

City

Bexley

State/Province

Ohio

ZIP/Postal Code

43209

Country

United States

Facility Name

Dermavant Investigative Site

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73071

Country

United States

Facility Name

Dermavant Investigate Site

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73072

Country

United States

Facility Name

Dermavant Investigative Site

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73072

Country

United States

Facility Name

Dermavant Clinical Site

City

Gresham

State/Province

Oregon

ZIP/Postal Code

97030

Country

United States

Facility Name

Dermavant Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Dermavant Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97223

Country

United States

Facility Name

Dermavant Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Dermavant Investigative Site

City

Johnston

State/Province

Rhode Island

ZIP/Postal Code

02919

Country

United States

Facility Name

Dermavant Investigative Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Dermavant Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

Facility Name

Dermavant Investigative Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

Facility Name

Dermavant Clinical Site

City

Bellaire

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

Dermavant Investigative Site

City

College Station

State/Province

Texas

ZIP/Postal Code

77845

Country

United States

Facility Name

Dermavant Investigative Site

City

Dripping Springs

State/Province

Texas

ZIP/Postal Code

78620

Country

United States

Facility Name

Dermavant Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Dermavant Clinical Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Dermavant Investigative Site

City

Pflugerville

State/Province

Texas

ZIP/Postal Code

78660

Country

United States

Facility Name

Dermavant Investigative Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75024

Country

United States

Facility Name

Dermavant Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78213

Country

United States

Facility Name

Dermavant Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Dermavant Investigative Site

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Dermavant Investigative Site

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

Country

United States

Facility Name

Dermavant Investigative Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Dermavant Investigative Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

Dermavant Investigative Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5K 1X3

Country

Canada

Facility Name

Dermavant Investigative Site

City

Surrey

State/Province

Bristish Columbia

ZIP/Postal Code

V3V 0C6

Country

Canada

Facility Name

Dermavant Investigative Site

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3R 6A7

Country

Canada

Facility Name

Dermavant Investigative Site

City

Ajax

State/Province

Ontario

ZIP/Postal Code

L1S 7K8

Country

Canada

Facility Name

Dermavant Clinical Site

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7L 6W6

Country

Canada

Facility Name

Dermavant Investigative Site

City

Cobourg

State/Province

Ontario

ZIP/Postal Code

K9A 0Z4

Country

Canada

Facility Name

Dermavant Investigative Site

City

Etobicoke

State/Province

Ontario

ZIP/Postal Code

M8X 1Y9

Country

Canada

Facility Name

Dermavant Investigative Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 1Y2

Country

Canada

Facility Name

Dermavant Clinical Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8S 1G5

Country

Canada

Facility Name

Dermavant Investigative Site

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P 1X2

Country

Canada

Facility Name

Dermavant Clinical Site

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P 1X3

Country

Canada

Facility Name

Dermavant Investigative Site

City

North Bay

State/Province

Ontario

ZIP/Postal Code

P1B 3Z7

Country

Canada

Facility Name

Dermavant Investigative Site

City

Oakville

State/Province

Ontario

ZIP/Postal Code

L6J 7W5

Country

Canada

Facility Name

Dermavant Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K2C 3N2

Country

Canada

Facility Name

Dermavant Investigative Site

City

Richmond Hill

State/Province

Ontario

ZIP/Postal Code

L4C 9M7

Country

Canada

Facility Name

Dermavant Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3H 5Y8

Country

Canada

Facility Name

Dermavant Investigative Site

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Dermavant Investigative Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8W 5L7

Country

Canada

Facility Name

Dermavant Investigative Site

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2X 2V1

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs

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

Plaque Psoriasis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial