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170 active trials for Psoriasis

APremilast After FumaRic Acid Ester Treatment

Patient treatment preference and treatment satisfaction of physicians and patients comparing fumaric acid ester therapy with subsequent apremilast treatment

Start: January 2017

Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab

The trial investigates the efficacy and safety of brodalumab against guselkumab in treatment for patients with moderate-to-severe plaque psoriasis who still have some remaining symptoms after ustekinumab treatment.

Start: November 2020

A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants

Plaque psoriasis is a chronic relapsing inflammatory skin disease that is characterized by keratinocyte hyper-proliferation and epidermal hyperplasia. Standard treatment for psoriasis generally requires long-term use of topical therapies, psoralen and ultraviolet A (PUVA), ultraviolet B (UVB) and/or systemic immunosuppressant therapies to achieve and maintain adequate disease control. This is a multicenter, randomized, double-blind study conducted in participants with moderate to severe plaque psoriasis. The study will evaluate the efficacy, safety, pharmacokinetic and pharmacodynamics profile of 960 milligram (mg) GSK2982772 administered as a once daily modified release (MR) formulation. Participants will be randomized in a 2:1 ratio to receive either 960 mg GSK2982772 or placebo for 12 weeks. The duration of the study, including Screening and follow-up, will be approximately 21 weeks for each participant.

Start: September 2020

Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases

The objective of this study is to evaluate the effect of adalimumab on health outcomes in participants with rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.

Start: May 2018

A Registry of Patients With Moderate to Severe Plaque Psoriasis

The main purpose of the current study will be to provide real - world evidence regarding the safety and effectiveness of secukinumab in the management of patients with moderate to severe chronic plaque psoriasis.

Start: December 2015

Study to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Psoriasis Treated With Subcutaneous Risankizumab Injection According to Standard of Care

Psoriasis is a chronic inflammatory skin condition that is characterized by symptoms such as pain, itching and discomfort. This can have severe impact on the quality of life including depression, embarrassment, and social isolation. The objective of this study is to evaluate how effective risankizumab is in changing the disease symptoms in adult participants with moderate to severe psoriasis. Risankizumab is an approved drug being developed for the treatment of psoriasis. Adult participants who are prescribed risankizumab treatment according to the local label will be enrolled in this study. Approximately 125 adult participants with moderate to severe psoriasis will be enrolled at multiple sites across Israel. Participants who are prescribed to receive subcutaneous risankizumab injection by their physician according to local label will be enrolled and will be followed for approximately 2 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, patient charts, questionnaires, and remote monitoring device (patch sensor).

Start: April 2021

A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. There is an unmet medical need for effective treatment in pediatric patients and this study is being done to evaluate risankizumab in pediatric participants with moderate to severe plaque psoriasis. This study will assess the change in disease symptoms. Risankizumab is a drug being studied for the treatment for plaque psoriasis in pediatric participants. This study has 4 parts. Part 1: Participants aged 12 < 18 will receive a fixed dose of risankizumab. Part 2: Participants aged 12 < 18 will receive; Period A: Risankizumab or ustekinumab based on body weight followed by; Period B: Risankizumab or no treatment. Period C: Re-treatment with risankizumab (if needed). Part 3 and Part 4: Participants aged 6 < 12 will receive risankizumab based on body weight. Around 132 participants will be enrolled in approximately 30 sites worldwide. Risankizumab and ustekinumab are given as a subcutaneous (under the skin) injection. Parts 1, 3, and 4: Risankizumab for 40 weeks with a follow-up call 20 weeks later for a study duration of approximately 65 weeks. Part 2: Period A: Risankizumab or ustekinumab for 16 weeks. Period B: Risankizumab or no treatment for 36 weeks. Period C: Re-treatment with risankizumab for 16 weeks. Follow-up call 20 weeks later for a study duration of approximately 81 weeks. Participants from each Part who meet eligibility criteria for an open-label extension (OLE) study may continue on risankizumab for 52 additional weeks. There may be a higher burden for study participants compared to standard treatment. Participants will attend monthly visits and medical assessments will check the effect of treatment through blood tests, questionnaires, and checking for side effects.

Start: July 2020

A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for IMISC

TARGET-DERM is a 5-year, longitudinal, observational study of adult and pediatric patients being managed for Atopic Dermatitis and other Immune-Mediated Inflammatory Skin Conditions (IMISC) in usual clinical practice. TARGET-DERM will create a research registry of patients with IMISC within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

Start: December 2018

Comparison of Secukinumab 300 mg Combined With a Lifestyle Intervention to Secukinumab Alone for the Treatment of Moderate to Severe Psoriasis Patients With Concomitant Metabolic Syndrome

Around 40% of moderate to severe psoriasis patients are affected by concomitant metabolic syndrome, making it one of the clinically most relevant comorbidities. Psoriasis as well as the metabolic syndrome are both characterized by a state of low-grade systemic inflammation (e.g. in the skin, joints, adipose tissue, liver or vascular endothelium). This shared pathophysiology makes systemic inflammation an attractive target for the treatment of both diseases. Secukinumab as well as lifestyle intervention are able to reduce systemic inflammation. This trial is designed to answer the question whether the combination of Secukinumab with lifestyle intervention can primarily improve skin symptoms and secondly cardiometabolic status more than Secukinumab alone in psoriasis patients with concomitant metabolic syndrome by targeting the shared pathophysiology behind both diseases, which is systemic inflammation.

Start: February 2018

Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis

Background: Psoriasis causes chronic inflammation in the body. Researchers want to see if a kind of vitamin B3 dietary supplement can help. This might lead to more treatment options. Objective: To test if the dietary supplement nicotinamide riboside can improve immune system function in the blood and skin of people with mild to moderate psoriasis. Eligibility: People ages 18-70 with mild to moderate active psoriasis not currently treated with biological therapy Design: Participations will be screened with: Medical and medication history Physical exam Measure of body mass index Skin exam Blood and urine tests Participants will have visit 1. They will have repeats of the screening tests. They will also have 2 skin biopsies. These will be from both lesions and unaffected areas. The areas will be injected with a numbing medicine. A round cutting device will remove small pieces of skin from each area. Participants will take the study supplement or a placebo starting at the first visit. Neither participants nor the study team will know which they receive. Participants will take capsules twice daily for a total of 4 weeks. Participants will then have visit 2. This will include the tests performed at visit 1. Participants may by contacted by phone or email between visits to see how they are doing. If participants develop any side effects in the 7 days after they stop taking the capsules, they may have another visit.

Start: August 2020

Triamcinolone Acetonide Injections in Mild-to-moderate Chronic Plaque Psoriasis With a Novel Needle-free Drug-delivery System

This is an observational pilot study comparing triamcinolone acetonide injections with the investigational Med-jet needle-free drug-delivery system as an alternative to using a conventional syringe and needle in patients with mild-to-moderate psoriasis. There will be five (5) visits necessary for study participation. The hypothesis is that the efficacy, safety, pain tolerance, and quality of life (QoL) metrics of the Med-jet needle-free drug-delivery system will be equal to or superior to that of a conventional syringe and needle.

Start: November 2020

Vascular Inflammation in Psoriasis - Apremilast

The purpose of the VIP-A study is to determine the effect of apremilast on aortic vascular inflammation, cardiometabolic biomarkers and body composition in patients with moderate-severe psoriasis.

Start: April 2017

Disease Trajectories in Atopic Dermatitis and Psoriasis

The clinical study investigates the course of disease in patients with chronic inflammatory skin diseases (atopic eczema and psoriasis). For this purpose, patients are asked in the context of their routine visits to take part in an examination and data collection, and are asked to donate biomaterials (blood, skin biopsies, skin swabs, tape strips, stool samples). Blood samples are used to analyze inflammation messengers. 4mm punch biopsies from lesional and non-lesional skin areas are used to analyze gene expression in the skin. Tape strips are pieces of transparent adhesive tapes to strip off most of the horny layer. The skin smears are superficial smears of three areas of skin with cotton swabs, which are used to examine bacteria on the skin. Overall, the study will help to monitor the disease course clinically and on the molecular level in participating patients for at least ten years and to collect information about the impact of various external factors including treatments. The study has no effect on the therapies of the disease, it serves only the accompanying data collection

Start: August 2017

Assessing Patient Confidence in Biologic Medications

In dermatology, biologic medications are used to treat conditions such as moderate-to-severe psoriasis. These medications generally function to decrease inflammation or disrupt the inflammatory cycle. Examples of biologic medications commonly used in dermatology include tumor necrosis factor-alpha (TNF-alpha), blockers/inhibitors (etanercept, infliximab, certolizumab pegol, golimumab), interleukin 12/23 blockers (ustekinumab) and interleukin 17A blockers (secukinumab, ixekizumab). Due to biologic medication's efficacy and safety profiles, they have revolutionized dermatology and the general medical field. However, patients may be apprehensive about choosing a biologic medication for a variety of reasons. These include hearing negative information about the drug from friends or family, being nervous about injection, or seeing the drug or its side effects negatively portrayed in the media. Many patients are not aware that clinical trial evidence for biologics exist, and instead may rely on anecdotal evidence in choosing to take these medications. Because fear of the drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. Physicians must be able to ascertain from where the fear originates and how it can be countered. By understanding what kind of information will allow patients to be confident in their decision to take a biologic, dermatologists can improve outcomes and initiate use of this drug. Furthermore, reducing fear of side effects or adverse events may improve adherence to treatment and may improve treatment outcomes. The investigators propose this study with the goal of learning whether patients are more confident in the potential success of biologic medications in treating their psoriasis after being presented with clinical trial evidence, anecdotal evidence, or both.

Start: June 2017

Brain Changes in Psoriasis After Secukinumab Treatment

The purpose of this study is to assess the effect of a biologic drug targeting the Interleukin (IL)-17 pathway (secukinumab) on brain plasticity and examine whether the plastic changes correlate with the improvement of perception of well-being, itch, and pain in participants with psoriasis.

Start: June 2021

Pleiotropic Role of TRPV1 in Psoriasis Inflammation

Widely expressed in the sensory nerve endings of the skin, Transient Receptor Potential Vanilloid 1 (TRPV1) is a receptor that plays an important role in the perception of pain and pruritus but also in skin inflammation, primarily by inducing the local release of several neuropeptides. Although the mechanisms by which TRPV1-sensitizing inflammatory mediators in damaged skin have received considerable attention, the role of TRPV1 in psoriasis has so far been little explored. However, two studies have reported that ablation of sensory nerves expressing TRPV1 reduced psoriasiform skin inflammation, demonstrating the neuronal contribution to inflammation in psoriasis. However, the expression of TRPV1 is not limited to neurons alone. TRPV1 is also expressed by epidermal keratinocytes and skin microvessels. For example, in 2018, transcriptomic analysis of psoriatic patient skins (by definition devoid of neuron nuclei) revealed that TRPV1 expression was increased in the skin of psoriatic patients suffering from itching (pruritus). Regarding human keratinocytes, it is recognized that the activation of TRPV1 present on their surface induces the release of pro-inflammatory factors such as cyclooxygenase-2. In addition, the investigators have demonstrated that TRPV1 has a pivotal role in the keratinocyte production of inflammatory mediators, which is mediated by the protease-activated receptor-2 (PAR-2). However, the role of vascular TRPV1 in inflammation is not described. The investigators hypothesize that in addition to neuronal TRPV1, non-neuronal TRPV1 receptors of non-neuronal cells (keratinocytes and endothelial cells) may be involved in the vicious circle of the inflammatory process characteristic of psoriasis. Putting TRPV1 at the center of the deregulation of the homeostatic balance including epithelial, neuronal and vascular inflammation in psoriasis is totally innovative.

Start: April 2021

Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With Moderate to Severe Plaque Psoriasis

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 main objective of this study is to assess maternal, fetal, and infant outcomes of women who are exposed to risankizumab during pregnancy with those in an unexposed comparator population. Risankizumab is an approved drug for the treatment of Plaque Psoriasis. Approximately 818 female participants with pregnancy will be enrolled (409 participants exposed to risankizumab and 409 without exposure) at multiple sites across the United States. Participants will not receive risankizumab as part of this study. Maternal and fetal outcomes during pregnancy for female participants who received risankizumab or other treatment will be followed for and up to 1 year after delivery There may be a higher burden for participants in this study compared to standard of care. Participants will attend visits determined by HCPs during the study at a hospital or clinic. The pregnancy outcomes including side effects will be collected during routine clinical care.

Start: June 2021

Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis

PSOBIOTEQ is a national multicentric prospective non interventional study which aims to constitute a French registry of cutaneous psoriasis patients initiating systemic treatment (excluding acitretin and phototherapy) for moderate to severe cutaneous psoriasis. The general objective of PSOBIOTEQ registry is to describe the use, benefits and risks of conventional, biological, biosimilar and small-molecule inhibitor of phosphodiesterase 4 (PDE4) systemic treatments in a real-life setting. The registry aims to meet many specific objectives and to fulfill ancillary studies. The PSOBIOTEQ registry concerns a largely similar population and has same objectives than the PSOBIOTEQ Cohort (NCT01617018). Indeed, data from the PSOBIOTEQ cohort will constitute the historical part of the registry and the cohort patients will pursue their follow-up in the registry framework, in order to enrich their follow up with new collected data.

Start: April 2021

A Phase ? Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis

Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis. After single asending dose and mutiple asending dose in health subjects. phase 2 results suggest Hemay005 60 mg BID has a higher curative effect trend?and adverse reactions were mild, so we choose 60 mg BID as Hemay005 phase 3 dosage And the patients with moderate to severe plaque psoriasis will be randomized into 2 cohorts(60mg BID and placebo) approximately 306 subjects will be enrolled (204 in 60mg BID and 102 in placebo). This study includes an 16-week treatment Period, then a 36-week Treatment Period without placebo.

Start: May 2021

Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of Hemay005 In Healthy Subjects

Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis. There were 3 dose cohorts (75mg, 90mg, 105mg) with 12 healthy subjects in each cohorts (6 males and 6 females). This study includes an 11-day Screening Period, a 1-day single dose and 7-days multiple doses Treatment Period.

Start: April 2021