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

NCT04053387 | Completed Phase 3 Results FDA Drug

• 1 other identifier: DMVT-505-3003
• Study Type: interventional
• Target: 763
• Locations: 2 countries
• Sites: 104

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.

Conditions

Plaque Psoriasis

Keywords

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

Outcome Measures

Primary Outcomes (14)

• 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%.

  Baseline to 44 weeks

• 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%.

  Baseline to 44 weeks

• 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.

  Baseline to 40 weeks

• 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.

  Baseline to 44 weeks

• 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.

  Baseline to 44 weeks

• 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.

  Baseline to 44 weeks

• 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.

  Baseline to 44 weeks

• 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

  Baseline to 40 weeks

• 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

  Baseline to 40 weeks

• 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.

  Baseline to 40 weeks

• 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).

  Baseline to 40 weeks

• 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).

  Baseline to 40 weeks

• 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.

  Baseline to 40 weeks

• 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.

  Baseline to 40 weeks

Study Arms (1)

Tapinarof (DMVT-505) Cream Group

EXPERIMENTAL

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

Drug: tapinarof cream, 1%

Interventions

tapinarof cream, 1% DRUG

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

Also known as: DMVT-505

Tapinarof (DMVT-505) Cream Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead
• IQVIA Biotech: collaborator

Study Sites (104)

Dermavant Investigative Site

Birmingham, Alabama, 35205, United States

Location

Dermavant Investigative Site

Phoenix, Arizona, 85032, United States

Location

Dermavant Investigative Site

Bryant, Arkansas, 72022, United States

Location

Dermavant Investigative Site

Fort Smith, Arkansas, 72916, United States

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Dermavant Investigative Site

Fountain Valley, California, 92708, United States

Location

Dermavant Investigative Site

Fremont, California, 94538, United States

Location

Dermavant Investigative Site

Fresno, California, 93720, United States

Location

Dermavant Investigative Site

Los Angeles, California, 90033, United States

Location

Dermavant Investigative Site

Los Angeles, California, 90045, United States

Location

Dermavant Investigative Site

Northridge, California, 91324, United States

Location

Dermavant Investigative Site

Oceanside, California, 92056, United States

Location

Dermavant Investigative Site

San Diego, California, 92123, United States

Location

Dermavant Investigative Site

Santa Ana, California, 92701, United States

Location

Dermavant Investigative Site

Santa Monica, California, 90404, United States

Location

Dermavant Investigative Site

Denver, Colorado, 80210, United States

Location

Dermavant Investigative Site

Cromwell, Connecticut, 06416, United States

Location

Dermavant Investigative Site

Boca Raton, Florida, 33431, United States

Location

Dermavant Investigative Site

Boynton Beach, Florida, 33437, United States

Location

Dermavant Investigative Site

Hialeah, Florida, 33016, United States

Location

Dermavant Investigative Site

Margate, Florida, 33063, United States

Location

Dermavant Investigative Site

Miami, Florida, 33144, United States

Location

Dermavant Investigative Site

Miramar, Florida, 33027, United States

Location

Dermavant Investigative Site

Boise, Idaho, 83713, United States

Location

Dermavant Investigative Site

Rolling Meadows, Illinois, 60008, United States

Location

Dermavant Investigative Site

Evansville, Indiana, 47714, United States

Location

Dermavant Investigative Site

Indianapolis, Indiana, 46250, United States

Location

Dermavant Investigative Site

New Albany, Indiana, 47150, United States

Location

Dermavant Investigative Site

Plainfield, Indiana, 46168, United States

Location

Dermavant Investigative Site

Overland Park, Kansas, 66215, United States

Location

Dermavant Investigative Site

Louisville, Kentucky, 40217, United States

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Dermavant Investigative Site

Owensboro, Kentucky, 42303, United States

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Dermavant Investigative Site

Baton Rouge, Louisiana, 70809, United States

Location

Dermavant Investigative Site

New Orleans, Louisiana, 70115, United States

Location

Dermavant Investigative Site

Rockville, Maryland, 20850, United States

Location

Dermavant Investigative Site

Boston, Massachusetts, 02115, United States

Location

Dermavant Investigative Site

Bay City, Michigan, 48706, United States

Location

Dermavant Investigative Site

Clarkston, Michigan, 48346, United States

Location

Dermavant Clinical Site

Detroit, Michigan, 48202, United States

Location

Dermavant Investigational Site

Detroit, Michigan, 48202, United States

Location

Dermavant Investigative Site

Fort Gratiot, Michigan, 48059, United States

Location

Dermavant Investigative Site

Warren, Michigan, 48088, United States

Location

Dermavant Investigative Site

Fridley, Minnesota, 55432, United States

Location

Dermavant Investigative Site

Saint Joseph, Missouri, 64506, United States

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Dermavant Investigative Site

Omaha, Nebraska, 68144, United States

Location

Dermavant Clinical Site

Las Vegas, Nevada, 89148, United States

Location

Dermavant Investigative Site

Las Vegas, Nevada, 89148, United States

Location

Dermavant Investigative Site

East Windsor, New Jersey, 08520, United States

Location

Dermavant Investigative Site

Hackensack, New Jersey, 07601, United States

Location

Dermavant Investigative Site

Verona, New Jersey, 07044, United States

Location

Dermavant Clinical Site

Brooklyn, New York, 11203, United States

Location

Dermavant Investigative Site

Kew Gardens, New York, 11374, United States

Location

Dermavant Investigative Site

New York, New York, 10029, United States

Location

Dermavant Investigative Site

Rochester, New York, 14623, United States

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Dermavant Investigative Site

Stony Brook, New York, 11790, United States

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Dermavant Clinical Site

Watertown, New York, 13601, United States

Location

Dermavant Investigative Site

Cary, North Carolina, 27518, United States

Location

Dermavant Investigative Site

High Point, North Carolina, 27262, United States

Location

Dermavant Investigative Site

Wilmington, North Carolina, 28405, United States

Location

Dermavant Investigative Site

Winston-Salem, North Carolina, 27157, United States

Location

Dermavant Investigative Site

Beachwood, Ohio, 44122, United States

Location

Dermavant Investigative Site

Bexley, Ohio, 43209, United States

Location

Dermavant Investigative Site

Norman, Oklahoma, 73071, United States

Location

Dermavant Investigate Site

Norman, Oklahoma, 73072, United States

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Dermavant Investigative Site

Norman, Oklahoma, 73072, United States

Location

Dermavant Clinical Site

Gresham, Oregon, 97030, United States

Location

Dermavant Investigative Site

Portland, Oregon, 97210, United States

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Dermavant Investigative Site

Portland, Oregon, 97223, United States

Location

Dermavant Investigative Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Dermavant Investigative Site

Johnston, Rhode Island, 02919, United States

Location

Dermavant Investigative Site

Charleston, South Carolina, 29407, United States

Location

Dermavant Investigative Site

Nashville, Tennessee, 37215, United States

Location

Dermavant Investigative Site

Arlington, Texas, 76011, United States

Location

Dermavant Clinical Site

Bellaire, Texas, 77401, United States

Location

Dermavant Investigative Site

College Station, Texas, 77845, United States

Location

Dermavant Investigative Site

Dripping Springs, Texas, 78620, United States

Location

Dermavant Investigative Site

Houston, Texas, 77004, United States

Location

Dermavant Clinical Site

Houston, Texas, 77030, United States

Location

Dermavant Investigative Site

Pflugerville, Texas, 78660, United States

Location

Dermavant Investigative Site

Plano, Texas, 75024, United States

Location

Dermavant Investigative Site

San Antonio, Texas, 78213, United States

Location

Dermavant Investigative Site

San Antonio, Texas, 78229, United States

Location

Dermavant Investigative Site

Webster, Texas, 77598, United States

Location

Dermavant Investigative Site

West Jordan, Utah, 84088, United States

Location

Dermavant Investigative Site

Norfolk, Virginia, 23502, United States

Location

Dermavant Investigative Site

Spokane, Washington, 99202, United States

Location

Dermavant Investigative Site

Edmonton, Alberta, T5K 1X3, Canada

Location

Dermavant Investigative Site

Surrey, Bristish Columbia, V3V 0C6, Canada

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Dermavant Investigative Site

Surrey, British Columbia, V3R 6A7, Canada

Location

Dermavant Investigative Site

Ajax, Ontario, L1S 7K8, Canada

Location

Dermavant Clinical Site

Burlington, Ontario, L7L 6W6, Canada

Location

Dermavant Investigative Site

Cobourg, Ontario, K9A 0Z4, Canada

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Dermavant Investigative Site

Etobicoke, Ontario, M8X 1Y9, Canada

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Dermavant Investigative Site

Hamilton, Ontario, L8N 1Y2, Canada

Location

Dermavant Clinical Site

Hamilton, Ontario, L8S 1G5, Canada

Location

Dermavant Investigative Site

Markham, Ontario, L3P 1X2, Canada

Location

Dermavant Clinical Site

Markham, Ontario, L3P 1X3, Canada

Location

Dermavant Investigative Site

North Bay, Ontario, P1B 3Z7, Canada

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Dermavant Investigative Site

Oakville, Ontario, L6J 7W5, Canada

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Dermavant Investigative Site

Ottawa, Ontario, K2C 3N2, Canada

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Dermavant Investigative Site

Richmond Hill, Ontario, L4C 9M7, Canada

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Dermavant Investigative Site

Toronto, Ontario, M3H 5Y8, Canada

Location

Dermavant Investigative Site

Waterloo, Ontario, N2J 1C4, Canada

Location

Dermavant Investigative Site

Windsor, Ontario, N8W 5L7, Canada

Location

Dermavant Investigative Site

Montreal, Quebec, H2X 2V1, Canada

Location

Related Publications (2)

• 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.

  PMID: 40600584 DERIVED

• 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.

  PMID: 37697121 DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Lead, Late-Stage Clinical Development
• Organization: Organon and Co

pdrl@organon.com

551-430-6000

Study Officials

• Victoria Butners

  Dermavant Sciences GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: August 12, 2019
• Study Start: August 13, 2019
• Primary Completion: April 6, 2021
• Study Completion: April 6, 2021
• Last Updated: August 6, 2025
• Results First Posted: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (85); CA (19)