Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis

NCT05142774 | Completed Phase 3 Results FDA Drug

• 1 other identifier: DMVT-505-3103
• Study Type: interventional
• Target: 728
• Locations: 2 countries
• Sites: 112

Brief Summary

This is an open-label, long-term multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in subjects with atopic dermatitis. Subjects in this study have completed treatment in one of two Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) or completed treatment in the DMVT-505-2104 study, or directly enrolled into this study. This study will consist of up to 48 weeks of treatment and a 1 week safety follow-up period.

Conditions

Atopic Dermatitis

Keywords

eczema; pediatric; tapinarof; phase 3; topical

Outcome Measures

Primary Outcomes (26)

• Number of Subjects With Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events

  For rollover subjects, all AEs reported in this extension study were considered as TEAEs except for those AEs ongoing at the end of previous studies but resolved prior to the Visit 1 date for this extension study. For direct-enrolling subjects, all AEs that start after the first dose of study drug will be considered a TEAE.

  Baseline to Week 49

• 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 previous studies but resolved prior to the Visit 1 date for this extension study. Subjects could have reported more than one TEAE.

  Baseline to Week 49

• Change From Baseline in Clinical Laboratory Values (g/L)

  The mean chemistry and hematology parameters were assessed for changes and trends over the course of the study.

  Baseline to Week 48

• Change From Baseline in Clinical Laboratory Values (U/L)

  The mean chemistry parameters were assessed for changes and trends over the course of the study.

  Baseline to Week 48

• Change From Baseline in Clinical Laboratory Values (mmol/L)

  The mean chemistry parameters were assessed for changes and trends over the course of the study.

  Baseline to Week 48

• Change From Baseline in Clinical Laboratory Values (Umol/L)

  The mean chemistry parameters were assessed for changes and trends over the course of the study.

  Baseline to Week 48

• Change From Baseline in Clinical Laboratory Values (10^9 Cells/L)

  The mean hematology parameters were assessed for changes and trends over the course of the study.

  Baseline to Week 48

• Change From Baseline in Clinical Laboratory Values (%)

  The mean hematology parameters were assessed for changes and trends over the course of the study.

  Baseline to Week 48

• Change From Baseline in Clinical Laboratory Values (L/L)

  The hematology parameter, Hematocrit, was assessed for changes and trends over the course of the study.

  Baseline to Week 48

• Change From Baseline in Clinical Laboratory Values (pg)

  The hematology parameter, Ery. Mean Corpuscular Hemoglobin was assessed for changes and trends over the course of the study.

  Baseline to Week 48

• Change From Baseline in Clinical Laboratory Values (fl)

  The hematology parameter, Ery. Mean Corpuscular Volume, was assessed for changes and trends over the course of the study.

  Baseline to Week 48

• Change From Baseline in Clinical Laboratory Values (10^12 Cells/L)

  The hematology parameter, Erythrocytes, was assessed for changes and trends over the course of the study.

  Baseline to Week 48

• Complete Disease Clearance During LTE: Number of Subjects Achieving Disease Clearance vIGA-AD =0 (Clear) While on Therapy for Subjects Entered LTE vIGA-AD ≥ 1 (Almost Clear )

  The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point (0-4) morphological assessment of overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Higher vIGA-AD scores represents more severe disease.

  Baseline to Week 48

• Response During LTE: Number of Subjects Achieving vIGA-AD =0 or 1 (Clear or Almost Clear) While on Therapy for Subjects Who Entered LTE With vIGA-AD ≥ 2 (Mild)

  The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point (0-4) morphological assessment of overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Higher vIGA-AD scores represents more severe disease.

  Baseline to Week 48

• Absolute 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. Assessment of BSA with Atopic Dermatitis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage \[Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)\]. Lesions on the scalp will not be included in the calculation of %BSA affected. Estimates of the % involvement in each body region will be multiplied by the fraction of total body area to obtain the total %BSA involved by region and overall.

  Baseline to Week 48

• 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. Assessment of BSA with Atopic Dermatitis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage \[Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)\]. Lesions on the scalp will not be included in the calculation of %BSA affected. Estimates of the % involvement in each body region will be multiplied by the fraction of total body area to obtain the total %BSA involved by region and overall.

  Baseline to Week 48

• Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score

  Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses the change from baseline in EASI score in all subjects, including those on and those off therapy. The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. The subject's scalp is excluded from this assessment. Higher EASI scores indicate more severe disease.

  Baseline to Week 48

• Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score

  Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses the % change from baseline in EASI score in all subjects, including those on and those off therapy. The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. The subject's scalp is excluded from this assessment. Higher EASI scores indicate more severe disease.

  Baseline to Week 48

• Percent of Subjects With ≥ 50% Improvement in Eczema Area and Severity Index (EASI) From Baseline at Week 48.

  The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.

  Baseline to Week 48

• Percent of Subjects With ≥ 75% Improvement in Eczema Area and Severity Index (EASI) From Baseline at Week 48.

  The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. The subject's scalp is excluded from this assessment. Higher EASI scores indicate more severe disease.

  Baseline to Week 48

• Percent of Subjects With ≥ 90% Improvement in Eczema Area and Severity Index (EASI) From Baseline at Week 48.

  The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. The subject's scalp is excluded from this assessment. Higher EASI scores indicate more severe disease.

  Baseline to Week 48

• Mean Change in Peak Pruritis-Numeric Rating Scale (PP-NRS) From Baseline

  The Peak Pruritus Numeric Rating Scale (PP-NRS) is used to quickly assess itch/pruritus severity over a 24-hour period. The PP-NRS is scored on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". The subject or caregiver will utilize the scale to assess peak pruritis once per day and record the results in their diaries. The daily ratings are averaged to generate a score for the week.

  Baseline to Week 48

• Number of Subjects With a Baseline Peak Pruritis-Numeric Rating Scale (PP-NRS) Score ≥ 4 Who Achieve ≥ 4-point Reduction in the PP-NRS From Baseline

  The Peak Pruritus Numeric Rating Scale (PP-NRS) is used to quickly assess itch/pruritus severity over a 24-hour period. The PP-NRS is scored on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". The subject or caregiver will utilize the scale to assess peak pruritis once per day and record the results in their diaries. The daily ratings are averaged to generate a score for the week.

  Baseline to Week 48

• Change From Baseline in Vital Signs - Pulse

  The mean vital sign parameters were assessed for changes and trends over the course of the study. Shifts from Baseline in vital sign parameters were assessed for clinical relevance.

  Baseline to Week 48

• Change From Baseline in Vital Signs - Blood Pressure (Systolic and Diastolic)

  The mean vital sign parameters were assessed for changes and trends over the course of the study. Shifts from Baseline in vital sign parameters were assessed for clinical relevance.

  Baseline to Week 48

• Change From Baseline in Vital Signs - Temperature

  The mean vital sign parameters were assessed for changes and trends over the course of the study. Shifts from Baseline in vital sign parameters were assessed for clinical relevance.

  Baseline to Week 48

Study Arms (1)

tapinarof cream

EXPERIMENTAL

Subjects entering with vIGA-AD (Validated Investigator Global Assessment of Atopic Dermatitis) ≥1 receive treatment with study drug until they achieve vIGA-AD=0, at which time treatment is discontinued and subjects are monitored for durability of response (remittive response). If/when disease worsening occurs (vIGA-AD ≥2), treatment is re-initiated and continued until vIGA-AD =0 is achieved. Subjects entering with a vIGA-AD=0 discontinue treatment and are monitored for duration of remittive response. If/when disease worsening occurs (vIGA-AD ≥2), treatment is re-initiated and continued until vIGA-AD =0 is achieved. This treatment and re-treatment pattern of use continue until the end of the study.

Drug: Tapinarof cream, 1%

Interventions

Tapinarof cream, 1% DRUG

Tapinarof cream, 1%, applied daily to affected areas by subjects or their caregivers based on vIGA-AD. Subjects are advised to choose the application time they prefer and apply the study drug at that approximate time each day of study participation.

tapinarof cream

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For Roll-over Subjects Only:
• Met the criteria as a Study Completer in one of three studies (DMVT-505-3101 study, DMVT-505-3102 study, or DMVT-505-2104 study).
• Must not be pregnant at Baseline
• For Direct-Enrolling Subjects Only:
• Male and female subjects ages 2 years to \< 18 years at the time of consent with clinical diagnosis of AD
• Subjects with a vIGA-AD™ score of ≥ 3 and AD covering ≥ 40% of the BSA at Screening and Baseline (pre-randomization), or subjects with a vIGA-AD™ score of 2 at Screening and Baseline (pre-randomization) regardless of BSA. Subjects must have screened for the DMVT-505-3101 or DMVT-505-3102 study and failed to meet BSA and/or vIGA-AD™ eligibility criteria.
• AD present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old
• Must not be pregnant at Screening or Baseline
• For All Subjects:
• Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
• Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent

You may not qualify if:

• For Rollover Subjects Only:
• Subjects who were not receiving study drug at the time of the last visit in the pivotal study (DMVT-505-3101, DMVT-505-3102, or DMVT-505-2104)
• Used a prohibited concomitant product or procedure to treat AD during the pivotal study.
• Had an SAE that was related to treatment or experienced an AE that led to permanent discontinuation of treatment in the pivotal study.
• Pregnant females
• For Direct-Enrolling Subjects:
• Immunocompromised at screening
• Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals within one week prior to baseline visit
• Significant dermatological or inflammatory condition other than AD that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN).
• Screening total bilirubin \> 1.5x ULN
• Current or chronic history of liver disease
• Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
• Subjects who would not be considered suitable for topical therapy
• Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer)

Sponsors & Collaborators

• Organon and Co: lead

Study Sites (112)

Dermavant Investigative Site

Birmingham, Alabama, 35244, United States

Location

Dermavant Investigative Site

Phoenix, Arizona, 85032, United States

Location

Dermavant Investigative Site

Scottsdale, Arizona, 85255, United States

Location

Dermavant Investigative Site

Scottsdale, Arizona, 85260, 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

Cerritos, California, 90702, United States

Location

Dermavant Investigative Site

Fountain Valley, California, 92708, United States

Location

Dermavant Investigative Site

Fremont, California, 94538, United States

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Dermavant Investigative Site

Huntington Beach, California, 92647, United States

Location

Dermavant Investigative Site

Inglewood, California, 90301, United States

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Dermavant Investigative Site

Lancaster, California, 93534, United States

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Dermavant Investigative Site

Long Beach, California, 90806, United States

Location

Dermavant Investigative Site

Los Angeles, California, 90017, 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

Mission Viejo, California, 92691, United States

Location

Dermavant Investigative Site

Sacramento, California, 95815, United States

Location

Dermavant Investigative Site

San Diego, California, 92123, United States

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Dermavant Investigative Site

San Francisco, California, 94115, 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

Thousand Oaks, California, 91320, United States

Location

Dermavant Investigative Site

Thornton, Colorado, 80112, United States

Location

Dermavant Investigative Site

Washington D.C., District of Columbia, 20037, United States

Location

Dermavant Investigative Site

Boca Raton, Florida, 33428, United States

Location

Dermavant Investigative Site

Boca Raton, Florida, 33486, United States

Location

Dermavant Investigative Site

Brandon, Florida, 33511, United States

Location

Dermavant Investigative Site

Coral Gables, Florida, 33146, United States

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Dermavant Investigative Site

Delray Beach, Florida, 33484, United States

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Dermavant Investigative Site

Hialeah, Florida, 33016, United States

Location

Dermavant Investigative Site

Jacksonville, Florida, 32256, United States

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Dermavant Investigative Site

Margate, Florida, 33063, United States

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Dermavant Investigative Site

Miami, Florida, 33165, United States

Location

Dermavant Investigative Site

Miami, Florida, 33173, United States

Location

Dermavant Investigative Site

Miami Lakes, Florida, 33014, United States

Location

Dermavant Investigative Site

Orlando, Florida, 32801, United States

Location

Dermavant Investigative Site

Pinellas Park, Florida, 33781, United States

Location

Dermavant Investigative Site

Sweetwater, Florida, 33172, United States

Location

Dermavant Investigative Site

Tampa, Florida, 33607, United States

Location

Dermavant Investigative Site

Marietta, Georgia, 30060, United States

Location

Dermavant Investigative Site

Sandy Springs, Georgia, 30328, United States

Location

Dermavant Investigative Site

Savannah, Georgia, 31406, United States

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Dermavant Investigative Site

Snellville, Georgia, 30078, United States

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Dermavant Investigative Site

Chicago, Illinois, 60611, United States

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Dermavant Investigative Site

Evansville, Indiana, 47715, United States

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Dermavant Investigative Site

Plainfield, Indiana, 46168, United States

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Dermavant Investigative Site

Overland Park, Kansas, 66210, United States

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Dermavant Investigative Site

Lexington, Kentucky, 40517, United States

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Dermavant Investigative Site

Louisville, Kentucky, 40217, United States

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Dermavant Investigative Site

Louisville, Kentucky, 40241, United States

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Dermavant Investigative Site

Owensboro, Kentucky, 42301, United States

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Dermavant Investigative Site

Baton Rouge, Louisiana, 70808, United States

Location

Dermavant Investigative Site

Baton Rouge, Louisiana, 70809, United States

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Dermavant Investigative Site

Covington, Louisiana, 70433, United States

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Dermavant Investigative Site

Monroe, Louisiana, 71201, United States

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Dermavant Investigative Site

New Orleans, Louisiana, 70115, United States

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Dermavant Investigative Site

Largo, Maryland, 20774, United States

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Dermavant Investigative Site

Rockville, Maryland, 20850, United States

Location

Dermavant Investigative Site

Bay City, Michigan, 48706, United States

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Dermavant Investigative Site

Clarkston, Michigan, 48346, United States

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Dermavant Investigative Site

Warren, Michigan, 48088, United States

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Dermavant Investigative Site

Ypsilanti, Michigan, 48197, United States

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Dermavant Investigative Site

New Brighton, Minnesota, 55112, United States

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Dermavant Investigative Site

Missoula, Montana, 59808, United States

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Dermavant Investigative Site

Omaha, Nebraska, 68144, United States

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Dermavant Investigative Site

East Windsor, New Jersey, 08520, United States

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Dermavant Investigative Site

Garden City, New York, 11530, United States

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Dermavant Investigative Site

New York, New York, 10075, United States

Location

Dermavant Investigative Site

Charlotte, North Carolina, 28277, United States

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Dermavant Investigative Site

Bexley, Ohio, 43209, United States

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Dermavant Investigative Site

Cleveland, Ohio, 44106, United States

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Dermavant Investigative Site

Dayton, Ohio, 45414, United States

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Dermavant Investigative Site

Mason, Ohio, 45040, United States

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Dermavant Investigative Site

Mayfield Heights, Ohio, 44124, United States

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Dermavant Investigative Site

Norman, Oklahoma, 73071, United States

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Dermavant Investigative Site

Oklahoma City, Oklahoma, 73120, United States

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Dermavant Investigative Site

Tulsa, Oklahoma, 74114, United States

Location

Dermavant Investigative Site

Medford, Oregon, 97504, United States

Location

Dermavant Investigative Site

Portland, Oregon, 97210, United States

Location

Dermavant Investigative Site

Portland, Oregon, 97223, United States

Location

Dermavant Investigative Site

Portland, Oregon, 97239, United States

Location

Dermavant Investigative Site

Anderson, South Carolina, 29621, United States

Location

Dermavant lnvestigative Site

Greenville, South Carolina, 29615, United States

Location

Dermavant Investigative Site

Mt. Pleasant, South Carolina, 29445, United States

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Dermavant Investigative Site

North Charleston, South Carolina, 29420, United States

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Dermavant Investigative Site

Spartanburg, South Carolina, 29303, United States

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Dermavant Investigative Site

Knoxville, Tennessee, 37909, United States

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Dermavant Investigative Site

Memphis, Tennessee, 38119, United States

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Dermavant Investigative Site

Bellaire, Texas, 77401, United States

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Dermavant Investigative Site

Cypress, Texas, 77433, United States

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Dermavant Investigative Site

Dallas, Texas, 75230, United States

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Dermavant Investigative Site

Dripping Springs, Texas, 78620, United States

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Dermavant Investigative Site

Grapevine, Texas, 76051, United States

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Dermavant Investigative Site

Houston, Texas, 77004, United States

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Dermavant Investigative Site

San Antonio, Texas, 78213, United States

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Dermavant Investigative Site

San Antonio, Texas, 78218, United States

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Dermavant Investigative Site

San Antonio, Texas, 78229, United States

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Dermavant Investigative Site

Sugar Land, Texas, 77479, United States

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Dermavant Investigative Site

Webster, Texas, 77598, United States

Location

Dermavant Investigative Site

Richmond, Virginia, 23226, United States

Location

Dermavant Investigative Site

Spokane, Washington, 99202, United States

Location

Dermavant Investigative Site

Calgary, Alberta, T3A 2N1, Canada

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Dermavant Investigative Site

Surrey, British Columbia, V3R 6A7, Canada

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Dermavant Investigative Site

Winnipeg, Manitoba, R3M 3Z4, Canada

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Dermavant Investigative Site

Barrie, Ontario, L4M 7G1, Canada

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Dermavant Investigative Site

Cobourg, Ontario, K9A 0Z4, 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

Waterloo, Ontario, N2J 7G1, Canada

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Dermavant Investigative Site

Windsor, Ontario, N8W 1E6, Canada

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Dermavant Investigative Site

Montreal, Quebec, H2X 2V1, Canada

Location

Related Publications (1)

• 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

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

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

pdrl@organon.com

551-430-6000

Study Officials

• Diana Villalobos

  Dermavant Sciences, Inc.

  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

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 3, 2021
• Study Start: October 28, 2021
• Primary Completion: February 29, 2024
• Study Completion: March 7, 2024
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (102); CA (10)