CTRI/2026/02/105052尚未招募3 期
A Randomized, Multi-Centric, Two-Arm, Active-Controlled, Parallel-group, Assessor-Blind, Phase III, Comparative Study to Evaluate Efficacy and Safety of Roflumilast 0.3 percent Cream Compared to Calcipotriol 0.005 percent Ointment in Patients with Chronic Plaque Psoriasis
Sun Pharmaceutical Industries Limited (SPIL)19 个研究点 分布在 1 个国家目标入组 454 人开始时间: 2026年3月3日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 454
- 试验地点
- 19
研究概览
简要总结
This Phase III, randomized, assessor-blind, multi-center study aims to compare the safety and efficacy of Roflumilast 0.3 percent cream with Calcipotriol 0.005 percent ointment in patients diagnosed with chronic plaque psoriasis. The trial will be conducted across 15 to 20 qualified centers in India and will begin only after receiving regulatory and ethics committee approvals.
A total of approximately 454 patients will be enrolled, with equal distribution across both treatment arms. Participants will be randomized in a 1:1 ratio, stratified by baseline affected body surface area (BSA less than 10 percent and greater than or equal to 10 percent). Eligible patients must have a confirmed diagnosis of plaque psoriasis for at least six months, with lesions on the trunk or extremities (excluding face, scalp, palms, soles, and intertriginous areas), affecting 2 to 20 percent BSA and a PASI score of greater than or equal to 2.
The primary end point of the study is proportion of patients achieving 75 percent reduction from baseline in PASI score at Week 12. Efficacy will be assessed using percent BSA, PASI, and IGA scores, along with DLQI to evaluate patient-reported outcomes. Target lesion photographs will be taken at specific visits. Safety evaluations will include monitoring adverse events, vital signs, ECG, physical exams, and lab tests covering hematology, liver and kidney function, electrolytes, HbA1c, and urinalysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- 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 willing to provide written informed consent
- •Patients with a confirmed clinical diagnosis of plaque psoriasis (psoriasis vulgaris) fulfilling the following criteria at Screening: a) Patient was diagnosed at least 6 months prior to Screening b) The lesions must involve the trunk and or extremities [excluding face, scalp, palms, soles and intertriginous areas] and is amenable to topical treatment c) The affected area should be greater than or equal to 2 percent to less than or equal to 20 percent of body surface area (BSA) d) Psoriasis Area Severity Index (PASI) score of greater than or equal to 2 at Screening e) Stable disease (without any new lesions or progression of existing lesions) in last 4 weeks prior to Screening and during Screening and washout period
- •Patients who agree to discontinue all agents used to treat plaque psoriasis from Screening through the EOS visit
- •Women of childbearing potential must have a negative urine pregnancy test prior to Screening and Randomization and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of study (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence OR non-hormonal contraception [e.g. condoms with spermicide])
- •Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period) [No sperm donation is allowed during the study period].
排除标准
- •Patient will be excluded if any of the exclusion criteria listed below is met:
- •Patients with known hypersensitivity or any other contraindication to any of the Investigational products or its component
- •Patients with unstable forms of psoriasis (for example but not limited to: guttate, erythrodermic, pustular psoriasis, palmoplantar psoriasis, drug-induced psoriasis, etc.)
- •Patients with history of any other skin disorder (for example but not limited to: pigmentation, extensive scarring, pigmented lesions, sunburn, acne, ulcer, atrophic striae, ichthyosis, etc.), that in the opinion of Investigator, would interfere with the study medication application or efficacy and safety assessments
- •Patients with history of Vitamin D toxicity
- •Patients with previous treatment with topical Roflumilast or topical calcipotriol
- •Patients using any of the following drugs/ treatments: a.
- •Strong CYP450 inhibitors (like: ketoconazole, itraconazole, ritonavir, indinavir, clarithromycin, etc.) [Note: Patients can be included after 2 weeks of washout period] b.
- •Strong CYP450 inducers (like: barbiturates, nevirapine, phenytoin, rifampicin, etc.) [Note: Patients can be included after 2 weeks of washout period] c.
- •Topical agents for psoriasis (including but not limited to: corticosteroids [Class 1, 2 and 3], Vitamin D analogues, retinoids, PDE4 inhibitors, salicylic acid, pimecrolimus, tacrolimus, anthralin, tar, etc.) [Note: Patients can be included after 2 weeks of washout period] d.
- •Topical Class 4 corticosteroids [Note: Patients can be included after 4 weeks of washout period] e.
- •Systemic immunosuppressing agents (like fumaric acid, corticosteroids, methotrexate, retinoids, PDE4 inhibitors [including oral Roflumilast], cyclosporine, etc.) [Note: Patients can be included after 4 weeks of washout period] f.
- •Any type of Laser or Phototherapy [Note: Patients can be included if they have completed 4 weeks of washout period] g.
- •Biological agents [Note: Patients can be included if they have completed 8 weeks or 5 half-lives (whichever is longer) of washout period post-last dose]
- •Patients with history of any clinically significant medical and or psychological condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results [for example but not limited to: hepatic impairment (if ALT greater than or equal to 3 x upper limit of normal [ULN] OR AST greater than or equal to 3 x ULN OR ALP greater than or equal to 3 x ULN OR total bilirubin greater than or equal to 1.5 x ULN), renal impairment (Serum creatinine greater than or equal to 2 x ULN), hypercalcemia (serum calcium greater than or equal to 12 mg/dL), epilepsy or seizure disorder or any neurological disorder, uncontrolled diabetes (HbA1c greater than or equal to 9 percent)]
- •Pregnant and or lactating female
- •Patients with history of severe depression or suicidal ideation
- •Patient with positive report of human immunodeficiency virus (HIV) and/or hepatitis B virus (HbsAg) and/or hepatitis C virus (HCV) infection at Screening
- •Patients who have participated in another Investigational study within the 3 months prior to Screening or planning to participate in another clinical trial during the study
- •Employee of the Sponsor, Investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees of Sponsor or the Investigator.
研究者
Dr Pravin Ghadge
Sun Pharma Laboratories Limited
研究点 (19)
Loading locations...
相似试验
招募中
2/3 期
A research study on Typhoid Conjugate Vaccine manufactured by Serum Institute for the treatment of Typhoid and Paratyphoid treatment in the Indian participants between 6 months to 65 years of age, to check the effect of Typhoid vaccine in Indian Participants.CTRI/2025/06/089129Serum Institute of India Private Limited (SIIPL)2,729
尚未招募
3 期
A study evaluating the sleep improving effects and safety of Suvorexant in comparison to Lemborexant in participants with Insomnia.CTRI/2026/02/102974Sun Pharmaceutical Industries Limited (SPIL)410
进行中（未招募）
3 期
Phase III clinical trial in the treatment of pressure ulcers also known as bedsores, decubitus ulcers and pressure injuries.CTRI/2024/05/068094Centaur Pharmaceuticals Pvt. Ltd232
已完成
3 期
Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of DW5421A/DW5421B Compared to Monotherapy of DW5421ANCT07444762Daewon Pharmaceutical Co., Ltd.184
已完成
3 期
Effect of Fexuprazan tablets in Comparison to Esomeprazole Tablets for treatment of patients with Erosive EsophagitisCTRI/2024/02/062543Sun Pharma Laboratories Limited210