View clinical trials related to Moderate Plaque Psoriasis.
Filter by:Psoriasis is a long-term skin disease which causes red, itchy, scaly patches most commonly on the knees, elbows, scalp, and torso (chest, back, and abdomen). In participants with psoriasis, certain skin cells multiply much faster and the skin can develop rough patches that may be red or white with scales. There are many types of psoriasis, but plaque psoriasis is the most common. The exact cause of psoriasis is unknown, but researchers think it may be caused by the body's immune system not working properly. This study is designed to enroll 336 participants 18 years of age and older with have been diagnosed with moderate chronic plaque psoriasis for at least 6 months prior to Baseline (Day 1) and who have not previously been treated with a biologic treatment (natural substance that is made by using living cells in a laboratory). This is a Phase 4, randomized, open-label, assessor blinded, active comparator study with 2 Parts. Phase 4 studies test treatments that have already been approved to treat patients with a condition or disease. This study is open-label, which means that both participants and study doctors know which study treatment is given to participants Participants will be administered subcutaneous (SC) treatment of risankizumab every 12 weeks for up to 44 weeks or provided deucravacitinib oral tablets to be taken once daily. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Psoriasis is a skin disorder wherein skin cells multiply faster than normal, making the skin itchy and look patchy and red. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. The impact of Psoriasis on quality of life can be significant, especially in moderate-to-severe disease which affects approximately half of the participants with plaque Psoriasis. Participants with Psoriasis are marked by their disease physically, psychologically, and emotionally. In addition to the above, their disease exerts a negative effect on various dimensions of health-related quality of life such as daily activities and work productivity. This study is designed to provide information regarding the impact of risankizumab on short-term and long-term clinical parameters of Psoriasis as well as the patient-reported outcomes (PROs) in participants with a recent diagnosis (less than or equal to 24 months) of moderate Psoriasis who are naïve to advanced treatments. Risankizumab is an approved drug for the treatment of Plaque Psoriasis. Approximately 250 participants with a recent diagnosis of moderate plaque psoriasis (defined as less than or equal to 24 months since the first diagnosis of moderate Psoriasis), and naïve to advanced treatments (biologics, apremilast, and deucravacitinib) will be enrolled at approximately 20 sites in Greece. Participants will receive risankizumab as prescribed by their treating dermatologist in accordance with local authorization and independently from the study. Participants will be enrolled and observed for approximately two years. There is expected to be no additional burden for participants in this trial. Study visits comprised of private practices and hospital clinics as per standard of care.
The purpose of this study is to evaluate the efficacy of guselkumab compared to an inactive drug in participants with low body surface area moderate plaque psoriasis and special site involvement.
For patients with moderate plaque psoriasis who are intolerable to, have a contraindication to or have failed classical systemic treatments, the current commonly employed management strategy encompasses treatment with biologic agents. The direct and indirect costs of biologic treatment, accruing, among others, from the high drug acquisition and administration costs, the required baseline safety screening and subsequent routine monitoring as well as the potential loss of patients' working hours constitute a significant financial burden on the public healthcare system. In light of the above evidence, it appears that in routine care apremilast may fulfill an important gap in the treatment armamentarium of psoriasis by providing a promising treatment option to be employed prior to biologics, which has demonstrated efficacy even in hard-to-treat areas such as the scalp, nails, palms and soles, and has a limited manageable safety profile, while being more convenient and cost-effective than biologics. In view of the scarcity of real-world evidence regarding the impact of apremilast on the patients' health-related quality of life (HRQoL) and extent and severity of the disease, and under the consideration that the moderate psoriasis patient {defined as [10<body surface area (BSA)<20 or 10<psoriasis area severity index (PASI)<20] and 10<dermatology quality of life index (DLQI)<20}, naïve to biologic treatment was likely underrepresented in the pivotal ESTEEM trials since approximately 30% of the enrolled patients had been previously treated with biologic therapy, 28-30% had a baseline PASI score >20, and 48-52% had a BSA >20%, this study represents an attempt to examine the impact of apremilast in routine clinical practice settings in Greece on the patient with moderate plaque psoriasis when this therapeutic strategy precedes biologics in the treatment algorithm. Specifically, the present study aims to generate novel real-world evidence on the effect of apremilast treatment in biologic treatment naïve patients with moderate plaque psoriasis in terms of the patients' HRQoL, patient-perceived benefits of therapy, treatment response rate, and impact on nail, scalp and palmoplantar psoriatic involvement and severity of pruritus, while concurrently assessing apremilast survival rate and cost per PASI-75 responder in the routine clinical practice of Greece.