A PHASE III, MULTICENTRIC, COMPARATIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TAPINAROF CREAM 1% IN COMPARISION WITH PLACEBO OF TAPINAROF CREAM 1% IN ADULT PATIENTS WITH PLAQUE PSORIASIS.

M/s. Optimus Pharma Private Limited (Sekhmet Pharmaventures)10 个研究点分布在 1 个国家目标入组 213 人开始时间: 2025年11月26日最近更新: 2025年12月28日

试验速览

阶段: 3 期
状态: 招募中
发起方
入组人数: 213
试验地点: 10

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

Psoriasis is a chronic, immune-mediated skin disease that affects approximately 2% of persons worldwide. Topical therapies are the most preferred management option but it is associated with poor adherence and low patient satisfaction. Although existing topical therapies, including glucocorticoids, are efficacious, especially in short-term treatment of localized disease, some medications in this class have restrictions relating to duration and extent of use and application sites.

Tapinarof is a non-steroidal, topical aryl hydrocarbon receptor–modulating agent for the treatment of psoriasis. Tapinarof was found to bind directly to AhR, resulting in the downregulation of inflammatory cytokines, regulation of skin barrier protein expression, and antioxidant activity.

Optimus Pharma Private Limited has developed Tapinarof Cream 1% and intends to conduct a phase III clinical study in India. The present study has been planned to compare the efficacy and safety of Tapinarof Cream 1% with that of a Placebo of Tapinarof Cream 1% in the topical treatment of plaque psoriasis in adults.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•Patients of either gender, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study.
•Clinical diagnosis of chronic plaque psoriasis and stable disease for at least 6 months prior to the study.
•Body surface area involvement more than equal to 3 percent and less than equal to 20 percent (the patients scalp, palms, groin, fingernails, toenails, and soles should be excluded from the %BSA calculations).
•A PGA score of 2 (mild), 3 (moderate) or 4 (severe) at screening and baseline (pre-randomization)
•Women of childbearing potential must have a negative urine pregnancy test prior to study entry.
•Patients and their female partners of childbearing potential should agree to use contraceptive measures throughout the study and for at least 2 months after end of treatment.

排除标准

•Known hypersensitivity to the drug components (study drug or excipient) used during the study.
•Pregnant or lactating women.
•Patients with non plaque forms of psoriasis (erythrodermic, guttate or pustular psoriasis).
•Other inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
•Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters.
•Concurrent conditions or history of other diseases a) Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome) or medical history of positive human immunodeficiency virus (HIV) antibody at Screening visit.
•b) Chronic or acute systemic infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the Screening visit.
•c) Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox) skin infection within 1 week prior to the Screening visit.
•d) Significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigator’s opinion, would make it difficult to interpret data or assessments during the study.
•Use of any of the following medication within the indicated period before the Screening visit a) Minimum of 5 half-lives for biologic agents- eg, 12 months for rituximab; 8 months for ustekinumab; 5 months for secukinumab; 12 weeks for golimumab; 10 weeks for ixekizumab; 8 weeks for infliximab, adalimumab, or alefacept; and 4 weeks for etanercept.
•b) 4 weeks for systemic treatments: cyclosporin, interferon, methotrexate, apremilast, tofacitinib, mycophenolate, thioguanine, hydroxyurea, sirolimus, azathioprine, other systemic immunosuppressive or immunomodulating agents, fumaric acid derivatives, vitamin D3 and analogs (more than 5000 IU^day), retinoids (eg, acitretin, isotretinoin), psoralens, corticosteroids, or adrenocorticotropic hormone analogs.
•c) 2 weeks for immunizations with a live viral component, drugs known to possibly worsen psoriasis, such as beta-blockers (eg, propranolol), lithium, iodides, angiotensin-converting enzyme inhibitors, and indomethacin, unless on a stable dose for more than 12 weeks.
•d) With the exception of non-medicated emollients, 2 weeks for topical treatments including corticosteroids, antihistamines, immunomodulators, anthralin (dithranol), Vitamin D derivatives (eg, calcipotriene, calcipotriol), retinoids (Note: 4 weeks for tazarotene), or coal tar.
•Patients with active systemic infection that required oral, intramuscular, or intravenous administration of antibiotics, antifungal or antiviral agents within 4 weeks of Day
•Patients have used topical therapy within 2 weeks of randomization or systemic therapy or phototherapy (i.e., UVB, PUVA) for psoriasis within 28 days of randomization.
•Patients with active substance abuse or a history of substance abuse within 6 months prior to Screening.
•Current or a history of cancer within 5 years except for adequately treated skin basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix (surgical excision or electrodessication and curettage).
•Concurrent skin lesions in the treatment area that, in the opinion of the Investigator, would either interfere with study evaluations or affect the safety of the patient.
•Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or CV system abnormalities or laboratory abnormality that will affect the health of the patient or interfere with interpretation of the results.
•a) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than equal to 2.5x the upper limit of normal (ULN), total bilirubin more than 1.5 x ULN, total bilirubin more than ULN and less than equal to 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin less then 35 percent.
•b) Corrected QT (QTcF) interval more than 475 msec.
•Patient who has used any investigational drug or device within 30 days of randomization preceding informed consent or scheduled to participate in another clinical study involving an investigational product or investigational drug during the course of this study.
•Any observational finding (clinical evaluation or physical) that is interpreted by the medical researcher as a risk to the research participants participation in the clinical trial.
•Female participants who are in the reproductive age and do not agree to use acceptable methods of contraception (oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation).
•Presence of any other dermatological condition that might confound the disease assessment and treatment evaluation.

研究者

发起方

M/s. Optimus Pharma Private Limited (Sekhmet Pharmaventures)

申办方类型

Pharmaceutical industry-Indian

责任方

Principal Investigator

主要研究者

Mr Kartik Sahni

Insignia Clinical Services Pvt. Ltd.

研究点 (10)

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