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Psoriasis clinical trials

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NCT ID: NCT04746911 Completed - Psoriasis Clinical Trials

Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216)

Start date: March 1, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in pediatric subjects (ages 2 to 5 years old) with plaque psoriasis:

NCT ID: NCT04745429 Completed - Depression Clinical Trials

Non-pharmacological Mitigation of Psoriasis

Start date: February 19, 2020
Phase: N/A
Study type: Interventional

In the past few years, research has provided evidence for a possibility of dampening immune system by one's will after undergoing a specific training program. Aim of this study was to verity the efficacy in affecting both mind and body by assessing psoriasis activity and psychological functioning. Among the members of both of the groups intensity of skin lesions and pruritus were assessed, consultation regarding treatment took place and multiple questionnaires regarding sleep quality, mindfulness and depressive symptoms were distributed. Blood samples were collected to asses intensity of inflammation, including interleukins.

NCT ID: NCT04744363 Completed - Psoriasis Clinical Trials

Pharmacokinetics, Safety and Tolerability Study of AVT04 to EU Approved and US Licensed Stelara (Ustekinumab)

Start date: May 25, 2021
Phase: Phase 1
Study type: Interventional

Protocol Title: A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and US-licensed Stelara® in healthy adult subjects Short Title: A first-in-human randomized, double-blind study to compare AVT04 with EU-approved Stelara and US-licensed Stelara as a single-dose subcutaneous injection in healthy adult subjects Rationale: Alvotech (hereafter, the Sponsor) is developing AVT04 globally as a proposed biosimilar to the reference product Stelara (ustekinumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT04. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT04 and the reference products EU approved Stelara and US-licensed Stelara, in addition to evaluating the safety and tolerability of AVT04, when administered as a single 45 mg/0.5 mL SC dose.

NCT ID: NCT04728360 Completed - Plaque Psoriasis Clinical Trials

Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis

Start date: July 6, 2021
Phase: Phase 3
Study type: Interventional

This study is a multicenter, randomized, double-blind, parallel-arm, Phase 3 study designed to compare efficacy, safety, immunogenicity, and PK of BAT2206 with Stelara in patients with moderate to severe plaque psoriasis. The study is composed of a ≤ 28-day screening period, a 16-week initial treatment period (TP1), a 24-week secondary treatment period (TP2), a 12-week efficacy and safety follow-up period up to end-of-study visit, for a maximum total study duration of 56 weeks.

NCT ID: NCT04728165 Completed - Psoriasis Clinical Trials

Anti-Inflammatory Effects of Time-Restricted Feeding

Start date: June 9, 2021
Phase:
Study type: Observational

Background: Time-restricted feeding (TRF) means that a person eats only during certain hours of the day. In other studies, researchers have found that fasting can improve immune system function in healthy people. They want to see if TRF has the same effect on people with psoriasis. Objective: To test whether TRF can change metabolism and decrease some markers of inflammation in the blood of people with mild to moderate psoriasis. Eligibility: Males ages 18 to 80 with mild to moderate active psoriasis, and healthy volunteers Design: Participants will be screened with a medical history and medicine review. They will have a physical exam and blood tests. Their skin will be examined. They will have a nutritional evaluation. Their resting energy expenditure will be measured. For this, a clear plastic ventilation hood will be placed over the head for a short time. Participants will stay at the NIH Clinical Center for 4 1/2 days. They can watch TV, do work, do schoolwork, and other quiet activities. A small sensor will be placed under participants skin to measure blood glucose. For part of the study, participants will be housed in a small room called a metabolic chamber. They will wear a heart monitor. Participants will walk on a treadmill for 30 minutes each day at a comfortable speed. For 3 days, participants will eat all their daily calories between 8 am and 2 pm. They will fast for the other 18 hours of the day. They can drink water. Participants will complete mixed meal tests. They will drink a liquid meal for breakfast. Then they will give blood samples via intravenous (IV) catheter. Participation will last for 5 days....

NCT ID: NCT04720105 Completed - Plaque Psoriasis Clinical Trials

Combination of Halobetasol Propionate and Tazarotene Lotion (Duobrii®) for Palmoplantar Plaque Type Psoriasis

Start date: November 19, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this research study is to examine the effect of Duobrii® (halobetasol propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ) on plaque type psoriasis of the hands and/or feet.

NCT ID: NCT04713592 Completed - Psoriasis Clinical Trials

Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement

IMMprint
Start date: February 26, 2021
Phase: Phase 3
Study type: Interventional

Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. Palmoplantar (non-pustular) plaque psoriasis (PPPsO) represents a localized form of psoriasis in palms and soles. This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis with palmoplantar involvement and to assess change in disease symptoms. Risankizumab is an approved drug for the treatment of psoriasis. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo in Period A. In Period B, all the participants will receive risankizumab. Around 168 adult participants with a moderate to severe plaque psoriasis will be enrolled in approximately 55 sites across the world. Participants will receive single subcutaneous (administered under the skin) risankizumab or placebo in period A (16 weeks). In period B (36 weeks), all participants will receive subcutaneous risankizumab once every 12 weeks. 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, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT04711343 Completed - Psoriasis Clinical Trials

Comparative Study to Evaluate the Pharmacokinetics of BAT2306 vs Cosentyx® in Healthy Subjects

Start date: June 8, 2022
Phase: Phase 1
Study type: Interventional

It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT2306 Injection vs Cosentyx® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 216 healthy male subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single 150mg BAT2306 Injection or Cosentyx® (EU-licensed and US-licensed).

NCT ID: NCT04709354 Completed - Clinical trials for Rheumatoid Arthritis

Clinical and Dermoscopic Comparison of Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriasis Patients' Nails

Start date: January 1, 2021
Phase:
Study type: Observational

This study evaluates the fingernail findings of the rheumatoid arthritis, spondylopathy and psoriatic arthritis patient groups with the fingernails of psoriasis patients clinically and dermatoscopically and investigates the benefit of dermoscopy in the differentiation of these patients.

NCT ID: NCT04673786 Completed - Psoriasis Clinical Trials

A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis

Start date: January 11, 2021
Phase: Phase 3
Study type: Interventional

This study is a randomized, active-controlled, double-blind, phase 3 study to compare the efficacy and safety of CT-P43 to Stelara in patients with moderate to severe plaque psoriasis.