long term extension study of tapinarof cream, 1% for subjects with atopic dermatitis

Conditions: Atopic Dermatitis

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.

at the completion of the week 8 visit of study dmvt-505-3101 (nct05014568) or study dmvt-505-3102 (nct05032859) or the day 28 visit of study dmvt-505-2104 (nct05186805) (day 1 \[baseline\] in this study), all eligible subjects will be offered enrollment in this open-label long-term extension (ol-lte) study. approximately 125 additional pediatric subjects ages 2 to \< 18 years who are not eligible for participation in the phase 3 pivotal studies (dmvt-505-3101 or dmvt-505-3102) will be enrolled directly into this ol-lte 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 48 weeks for rollover subjects (baseline to final visit) with a 1-week safety follow-up period and approximately 52 weeks for direct-enrolling subjects (screening to final visit) with a 1-week safety follow-up period.

Eligibility criteria:
inclusion criteria: 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 exclusion criteria: for rollover subjects only: 1. 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) 2. used a prohibited concomitant product or procedure to treat ad during the pivotal study. 3. had an sae that was related to treatment or experienced an ae that led to permanent discontinuation of treatment in the pivotal study. 4. 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) * 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 participation in the study, interpretation of results, or ability to understand and give informed consent. * pregnant or lactating females * history of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation * previous known participation in a clinical study with tapinarof (previously known as gsk2894512 and wbi-1001)

Keywords: eczema pediatric tapinarof phase 3 topical