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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 2 years and older
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Trial locations and contacts

112 sites in 2 countries.

About this study

Official title: An Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of Tapinarof Cream, 1% in Subjects With Atopic Dermatitis

Conditions

Atopic Dermatitis

Being tested

Tapinarof cream, 1%

Keywords

eczema, pediatric, tapinarof, phase 3, topical

Medical subject headings

Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Baseline to Week 49

2. 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.

   Measured: Baseline to Week 49

3. 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.

   Measured: Baseline to Week 48

4. 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.

   Measured: Baseline to Week 48

5. 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.

   Measured: Baseline to Week 48

6. 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.

   Measured: Baseline to Week 48

7. 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.

   Measured: Baseline to Week 48

8. Change From Baseline in Clinical Laboratory Values (%)

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

   Measured: Baseline to Week 48

9. 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.

   Measured: Baseline to Week 48

10. 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.

    Measured: Baseline to Week 48

11. 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.

    Measured: Baseline to Week 48

12. 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.

    Measured: Baseline to Week 48

13. 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.

    Measured: Baseline to Week 48

14. 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.

    Measured: Baseline to Week 48

15. 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.

    Measured: Baseline to Week 48

16. 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.

    Measured: Baseline to Week 48

17. 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.

    Measured: Baseline to Week 48

18. 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.

    Measured: Baseline to Week 48

19. 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.

    Measured: Baseline to Week 48

20. 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.

    Measured: Baseline to Week 48

21. 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.

    Measured: Baseline to Week 48

22. 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.

    Measured: Baseline to Week 48

23. 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.

    Measured: Baseline to Week 48

24. 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.

    Measured: Baseline to Week 48

25. 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.

    Measured: Baseline to Week 48

26. 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.

    Measured: Baseline to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted3 Dec 2021
2. Study start28 Oct 2021
3. Primary completion29 Feb 2024
4. Study completion7 Mar 2024

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (3)Papers the sponsor has linked to this study.
• Other trials for Atopic DermatitisStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.