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Measuring plantar pressure during total contact softcast offloading versus conventional total contact cast offloading: a pilot study

Primary objective: Investigation of mean peak plantar pressure at the location of the diabetic foot ulcer and at 6 plantar regions of the foot (i.e. hallux, digits, first metatarsal, second to fifth metatarsals, midfoot, and heel) during total…

The Role of Nerves and Sensibility in Keloids: Functional Sensory Testing and Clinical Correlation

The primary objective will be to evaluate the sensation of the keloids as measured by Semmes-Weinstein monofilaments (SWM), Pressure Specified Sensory Device (PSSD) and/or Quantitative Sensory Testing (QST), compared between patients with and…

A randomized, double-blind, placebo-controlled, multi-center, dose-ranging Phase 2 study of rilzabrutinib followed by an open-label extension phase in patients with moderate-to-severe chronic spontaneous urticaria (CSU) who remain symptomatic despite the use of H1 antihistamine treatment

The purpose of the study is to evaluate how effective rilzabrutinib is and how safe it is, in reducing the signs and symptoms in patients with chronic spontaneous urticaria (CSU), who continue to have symptoms despite the use of H1-antihistamines (…

ImmUniverse Work Package 5 AD:
Better control and treatment of Atopic Dermatitis disease by exploring the universe of microenvironment imposed tissue signatures and their correlates in liquid biopsies

The main aim of this project is to obtain a better control and treatment of immune-mediated diseases by exploring the universe of microenvironment imposed tissue signatures and their correlates in liquid biopsies.

A Phase 3 Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ISIS 721744 in Patients with Hereditary Angioedema (HAE)

Primary objective: The primary objective of the study is to evaluate the clinical efficacy of ISIS 721744 in patients with hereditary angioedema (HAE).Secondary objective: Evaluate the effects of ISIS 721744 on the quality and pattern of HAE attacks…

Phase 2, randomized, parallel-group, double-blind, placebo-controlled study of sonelokimab in patients with active moderate to severe hidradenitis suppurativa

Primary Objective:1. To evaluate the efficacy of sonelokimab at 2 different dose levels (120 mg, 240 mg) compared with placebo in the treatment of participants withactive moderate to severe hidradenitis suppurativa.Secondary Objectives:1. To…

Clinical, virological, immunological, psychosocial and epidemiological consequences of the human MonkeypoX Virus outbreak, a PROspective observational cohort study (pro-MPX)

The aim of this study is to improve our understanding of clinical, virological, and psychosocial outcomes in patients with MPXVID. To get a better understanding of associated risk factors for MPXV infection, and to measure quality of life and stigma…

Longitudinal variation of blood based biomarkers in moderate-to-severe atopic dermatitis patients, a prospective cohort study

Primary Objective: To investigate longitudinal variation of blood-based biomarkers, their integration with disease severity, comorbidities, their association with standard care and characterization of adequate and inadequate responders to standard…

'Proof of concept study of the apllication of Active Chlorine in patients Treated for Chronic Leg Ulcera to speed up reepithelialisation' (ACTCU)

What is the effect in reepithelialisation of chronic ulcers using hypochlorous acid solution during 6 weeks.

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects with Moderate to Severe Atopic Dermatitis (Level-Up)

This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.

A Randomised, Double-Blind, Placebo-controlled, 32-week, Phase IIa trial to investigate the efficacy of OM-85 versus matched placebo in reducing disease severity in children aged 3 to 24 months with early clinical diagnosis of moderate atopic dermatitis

Primary Objective Primary objective is to assess the efficacy of OM-85 versus matched placebo in children with moderate AD in reducing disease severity over the first 16 weeks and the first 24 weeks of the treatment period.Secondary Objectives…

A randomized, double-blind, vehicle-controlled trial with safety run-in to assess the safety, tolerability and efficacy of DLQ02, a novel topical formulation Cyclosporine A (CsA), applied twice daily over four weeks to patients with plaque psoriasis.

To assess the safety, tolerability, pharmacodynamics and efficacy of two DLQ02 topical formulations in patients with plaque psoriasis. To assess systemic exposure of CsA and F6H8 after topical application.

An Open-Label, Long Term Safety and Efficacy Study of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)

This study has been transitioned to CTIS with ID 2023-509201-77-00 check the CTIS register for the current data. Primary ObjectiveTo evaluate the safety of long-term dosing with donidalorsen in patients with HAE. Secondary ObjectivesTo evaluate the…

A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid

This study has been transitioned to CTIS with ID 2023-508645-40-00 check the CTIS register for the current data. Parts A and B:To evaluate the efficacy of efgartigimod PH20 SC on achieving sustained remission in the treatment of participants with…

A virtual, decentralised observational follow-up study investigating feeding patterns in infancy and the associated parent-reported allergic manifestations, allergies and infections in childhood.

Given the worldwide-observed rapid increase in the prevalence of allergic diseases, it is likely that environmental risk factors, including geographic area and lifestyle factors play a substantial role in the development of allergies and other…

A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis

This study has been transitioned to CTIS with ID 2023-504869-23-00 check the CTIS register for the current data. 1. Sub-Study 1 (SS1): The primary study objective for SS1 is to evaluate the efficacy and safety of dose escalation to upadacitinib 30…

A First-in-Human, Double-Blind, Randomised, Vehicle-Controlled Phase I/II Proof of Concept Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of BEN2293 in Patients with Mild to Moderate Atopic Dermatitis.

PrimaryThe primary objective of this study is to assess the safety and tolerability of BEN2293, administered as multiple topical doses to increasing body surface area (BSA), in patients with mild to moderate AD.SecondaryPharmacokinetics· To…

Can we improve the management of Juvenile PsA patients by using a different disease activity measure?

Primary goal: to determine whether a combined disease activity measure correlates better with disease burden than the current disease measure. Primary study question: does the minimal disease activity JADAS (MDA-JADAS) correspond to the MDA…

Hyperbaric Oxygen Therapy for Pyoderma gangrenosum As a New Treatment Strategy

To investigate the therapeutic efficacy and feasibility of hyperbaric oxygen (HBO) in addition to standard wound care in patients with pyoderma gangrenosum wounds.

A single-centre, exploratory study to characterise the skin barrier and microbiome of patients with cutaneous T-cell lymphoma (CTCL)

• To investigate the microbiome composition of the nares, non-lesional skin and patches, plaques and tumours in lesional skin of CTCL patients, including all stages of the disease• Correlate microbiome (including S. aureus presence) and disease…