A clinical trial to study the effect of Apremilast Tablets in the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
- Conditions
- Health Condition 1: null- Moderate to Severe Plaque Psoriasis
- Registration Number
- CTRI/2016/10/007345
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Male or female subjects, aged >=18 years to <=65 years
2.Subjects who had moderate to severe plaque psoriasis for 6 months or longer and who are candidates for phototherapy or systemic therapy.
1.Pregnant or lactating women.
2.Subjects with known hypersensitivity to the study drug or any of the excipient.
3.Subject with history of current erythrodermic, guttate or pustular psoriasis
4.Subjects with psoriasis flare or rebound within 4 weeks prior to screening
5.Subjects 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.
6.Subjects have used biological therapy for psoriasis within 6 months of randomization.
7.Subjects with history of malignancy (except for treated [i.e., cured] basal cell or squamous cell in situ skin carcinomas and treated [i.e., cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence) within 5 years of screening
8.Subjects with evidence of skin conditions that would interfere with clinical assessments in the opinion of the investigator
9.Subjects with active substance abuse or a history of substance abuse within 6 months prior to Screening
10.Subjects with bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections.
11.Subject who have 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving psoriasis area severity index - 75 responsesTimepoint: 16 weeks
- Secondary Outcome Measures
Name Time Method 1.Proportion of subjects achieving Physicianâ??s Global Assessment (PGA) score of clear (0) or almost clear (1)Timepoint: 16 weeks;2.Proportion of subjects achieving PASI-50Timepoint: 16 weeks;3.Proportion of subjects achieving PASI-90Timepoint: 16 weeks;4.Proportion of patients who have taken rescue medication during the treatment period Time-pointTimepoint: 16 weeks