Clinical Research Directory

Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)

This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in subjects with CSU.

A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines

This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily \[b.i.d.\] by mouth \[p.o.\]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.

Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab in Chronic Spontaneous Urticaria

Chronic spontaneous urticaria (CSU) is an immune-mediated skin disorder characterized by pruritic wheals and/or angioedema. This study aims to evaluate the relationship between diet-derived antioxidant capacity and oxidative stress with CSU presence, disease activity, and response to omalizumab. Adults with active CSU and age/BMI-matched healthy controls will provide non-consecutive 3-day dietary records (two weekdays and one weekend day). Dietary antioxidant capacity will be calculated using ORAC metrics via BeBiS software. Oxidative stress biomarkers (total oxidant status, total antioxidant status, oxidative stress index, malondialdehyde, and advanced oxidation protein products) will be measured from venous blood samples. CSU disease activity will be assessed using UAS7 and UCT, along with an urticaria quality of life questionnaire. In CSU patients who receive omalizumab as clinically indicated, assessments will be repeated after 3 months to evaluate treatment response and associated changes in diet and oxidative stress markers.

ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar

ROLL'YN-OMA is a real-world study in patients receiving standard biologic therapies who have been in control and/or remission of their disease for at least 3 months and whose physician has independently decided, within the framework of a shared medical decision, to switch them to OMLYCLO®. The primary objective of this study is to evaluate the maintenance of this control and/or clinical remission 12 months after initiation of the biosimilar, and subsequently, patient satisfaction at 6 and 12 months.

A Multi Dose, Phase 2 Study of YH35324 in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines

This study aims to evaluate the efficacy and safety of lesigercept in approximately 150 participants with CSU. By enrolling participants with an inadequate response to H1-antihistamines, including those previously treated with omalizumab, this study is expected to provide evidence for the clinical utility of lesigercept and to further characterize its benefit-risk profile in the target participant population.

Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria

The purpose of this study is to compare the efficacy and safety of ICP-332 in moderate to severe chronic spontaneous urticaria subjects inadequately controlled by second generation H1-antihistamines

Analysis of the Role of IgE Proteoforms in Health and Disease

The goal of this observational study is to evaluate the role of IgE proteoforms in healthy volunteers and in patients with type I allergy, patients with chronic spontaneous urticaria, patients with a recent history of anaphylaxis, patients with mastocytosis, patients with hereditary alpha tryptasemia, patients with X-linked agammaglobulinemia (XLA), and patients undergoing desensitization for venom or medication allergy.

SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)

The goal of this observational study is to comprehensively profile six immune-mediated inflammatory diseases, including atopic dermatitis (AD), plaque psoriasis (PSO), hidradenitis suppurativa (HS), cutaneous T-cell lymphoma subtype mycosis fungoides (MF), chronic spontaneous urticaria (CSU), and cutaneous lupus erythematosus (CLE) in daily practice. Data will be compared with data from healthy volunteers. This study is part of the larger NGID (Next Generation ImmunoDermatology) initiative, of which the main objective is to develop infrastructure that enables personalised patient care. The main questions the SKINERGY study aims to answer are: * Which biomarkers can discriminate between responders and non-responders to treatment in patients with AD, CLE, CSU, HS, MF, and PSO? * How do disease-related biomarkers in patients with AD, CLE, CSU, HS, MF, and PSO differ from those in healthy volunteers? * Which (multi-omics) biomarkers are associated with disease subtypes and predict response or non-response to (targeted) therapies in daily clinical practice? * How do biomarker profiles compare across different cohorts of patients with immune-mediated inflammatory skin diseases (AD, CLE, CSU, HS, MF, PSO) * How do biomarker levels change over time in response to treatment in these patient populations? * Which skin tissue biomarkers are associated with disease progression or treatment response? * How do the genomic profiles of patients differ across diseases or correlate with treatment outcomes? * Can additional imaging biomarkers enhance the characterization of disease profiles or treatment monitoring over time? Researchers will compare both differences beween patients within a disease group in different treatment arms, as well as patients within the same treatment arm. Additionally, biomarker profiles of patients with different diseases will be evaluated. These comparisons will be made to see if shared or distinct biomarker patterns exist across diseases and treatments, which could inform patient stratification, optimize therapeutic decision-making, and identify potential targets for future interventions. Participants will start medication according to national guidelines for the treatment of their inflammatory skin disease (AD: Cyclosporin A, anti-IL4/13, or anti-JAK; PSO: anti-TNF, anti-IL23, ani-IL17, anti-TYK2; HS: anti-TNF, anti-IL17; MF: CHLORM, TSC, PUVA-UV-B; CSU: anti-IgE, Cyclosporin A, anti-BTK\*; CLE: TSC, HCQ, MTX) \*once approved and reimbursed in the Netherlands Participants will: * Take the prescribed medication for their skin disease (in line with standard care in the Netherlands). * Visit the clinic for a study visit combined with their standard care appointment 3 times (baseline, month 3, and month 6. An additional 4th visit at month 12 is optional). * Fill in an online set of questionnaires from home, 3 times during the study period (an additional 4th time is optional). * Patients with CSU fill in the UAS7 (and if applicable the AAS7) daily for the study period.