A Randomized, multicenter, double-blind, parallel group, three-arm, placebo-controlled trial to evaluate the bioequivalence of Tapinarof cream 1 Percent of Mylan Laboratories Ltd versus VTAMA® (Tapinarof cream 1 Percent, Dermavant Sciences Inc.) using the clinical endpoint in patients with plaque psoriasis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 28
- 主要终点
- Proportion of participants with treatment success defined as a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at the end of treatment.
研究概览
简要总结
· This will be a Randomized, multicenter, double-blind, parallel group, three-arm, placebo-controlled trial with primary objective to determine the bioequivalence (with clinical endpoint) of Mylan’s Tapinarof cream, 1% with the reference listed drug, VTAMA (Tapinarof 1%, Dermavant Sciences Inc.), and superiority of the Test and RLD with placebo.
· Sample size of the study will be approximately 450 participants; male or non-pregnant, non-lactating females aged between 18 to 75 years with a clinical diagnosis of stable (at least 6 months) plaque psoriasis involving 3 to 20% body surface area (BSA), not including the face, scalp, groin, palms, and soles in the BSA calculation for a period of 16 weeks.
· Participants will receive either Mylan’s Tapinarof Cream (n = 180), RLD (VTAMA cream 1%; n = 180) or Placebo (n = 90), once daily for 84 days (12 weeks). Participants will take the trial drug home and self-administer trial drug or have caregiver apply, if necessary, to affected areas once daily. At clinic visits, trial drug will be applied after safety and efficacy assessments have been conducted.
· At each contact with the participant, the investigator will seek information on adverse events by different safety assessments like physical examination, vital signs and clinical laboratory investigations etc.
· Telephonic follow-ups are scheduled between visits to assess AEs and concomitant medications, to review trial drug application procedures, and to confirm participant’s continued participation in the trial.
End of the Study (EOS) and Follow-up safety assessment will be done two weeks post last dose of trial treatment received during the randomized treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or non-pregnant, non-lactating females aged between 18 to 75 years with a clinical diagnosis of stable (at least 6 months) plaque psoriasis involving 3 to 20% body surface area (BSA)
- •A PGA score of 2 (mild), 3 (moderate), or 4 (severe)
- •Female participants should have been postmenopausal for at least 1 year.
排除标准
- •Females who are pregnant, breast feeding, or who wish to become pregnant during the trial period.
- •Current diagnosis of unstable forms of psoriasis
- •Other inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis
- •Current immunosuppression
- •Concurrent conditions or history of other inflammatory, infectious and immunocompromised diseases
- •Current or chronic history of liver disease, known hepatic or biliary abnormalities
- •Current or a history of cancer within 5 years,
- •Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas
- •A history of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator’s opinion, may interfere with the participants participation in the trial and ability to understand and give informed consent.
- •11.Planned surgery or hospitalization (anticipated to last > 72 hours) during the trial.
- •12.Any other medical condition that, in the opinion of the Investigator, renders the participants unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the participant.
- •Clinically significant abnormalities in ECG or Screening laboratory parameters
- •Non-cooperation with clinical trial staff.
结局指标
主要结局
Proportion of participants with treatment success defined as a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at the end of treatment.
时间窗: 12 weeks
次要结局
- To compare the body sites and size of treatment area.(To assess the safety and tolerability of trial treatments by reported adverse events.)
研究者
Dr Dharmesh Domadia
Cliantha Research Limited