Chronic Spontaneous Urticaria research hub
10 indexed studies · 1 currently recruiting
- active not recruitingPHASE3
An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib
This study looks at a medicine called remibrutinib for chronic hives. It checks how well it works and if it's safe for people who already took part in earlier studies. It also helps make sure participants can continue getting the medicine if they need it.
United States · Argentina · Australia - active not recruitingPHASE3
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
This study is testing a new medicine, barzolvolimab, for people with chronic spontaneous urticaria (CSU), also known as chronic hives. It aims to see if the medicine is safe and helps reduce hives better than a dummy medicine (placebo) for those whose current treatments aren't enough.
United States · Australia · Bulgaria - recruitingPHASE3
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
This study looks at a new medicine, LOU064, for teenagers aged 12-17 with chronic hives (CSU) that haven't improved with usual allergy medicines. It checks if LOU064 works, how safe it is, and how the body uses it over time.
United States · Argentina · Canada - active not recruitingPHASE3
Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.
This study looks at a new medicine called remibrutinib for chronic spontaneous urticaria (CSU), comparing it to a dummy treatment (placebo) and another existing medicine, omalizumab. It aims to see if remibrutinib is safe and helps reduce hives and itching in adults whose CSU isn't well controlled by usual allergy medicines.
Argentina · Brazil · Bulgaria - authorisedTherapeutic confirmatory (Phase III)
An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored remibrutinib study and are judged by the investigator to benefit from continued treatment with remibrutinib
This study is for people with ongoing itching and hives (Chronic Spontaneous Urticaria) who have already been taking remibrutinib in a Novartis study. It lets them continue treatment if their doctor thinks it's helping, to see if the medicine keeps working and is safe in the long term.
Germany · Spain · France - ongoing, recruitingTherapeutic exploratory (Phase II)
Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy, and Safety Study of Povorcitinib in Participants With Chronic Spontaneous Urticaria
This study is testing a new medicine, Povorcitinib, for people with chronic spontaneous urticaria (CSU), also known as chronic hives. It aims to see if the drug helps reduce itching and hives and if it's safe, compared to a dummy pill.
Germany · Poland - ongoing, recruitingPhase III and phase IV (Integrated)
Extending omalizumab treatment intervals in patients with chronic spontaneous urticaria (EXOTIC trial): a multicentre, randomized, open-label, non-inferiority trial.
This study looks at whether people with ongoing hives (chronic spontaneous urticaria) can take their Xolair medicine less often. It wants to see if stretching out the time between doses works just as well to control their hives, compared to the usual schedule.
Denmark - ongoing, recruitingTherapeutic exploratory (Phase II)
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria
This study is testing a new medicine, EP262, for people with chronic spontaneous urticaria (CSU), also known as chronic hives. It aims to see if the medicine can reduce itching and the number of hives compared to a dummy medicine.
Poland · Germany · Spain - ongoing, recruitingTherapeutic exploratory (Phase II)
Proof of concept study to assess the efficacy and safety of Danicopan (factor D inhibitor) in adult patients with chronic spontaneous urticaria resistant to H1-antihistamine treatment (DANICSU).
This study looks at a new medicine called Danicopan for adults with long-lasting hives (urticaria) that haven't gotten better with standard allergy pills. It aims to see if Danicopan is safe and helps reduce hives, especially for those with different allergy levels.
Germany - ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence Study
A RANDOMIZED PHASE I, DOUBLE-BLIND, PARALLEL, COMPARATIVE ASSESSMENT OF PHARMACOKINETICS, SAFETY, PHARMACODYNAMICS, AND IMMUNOGENICITY OF LT-01 (AN OMALIZUMAB BIOSIMILAR CANDIDATE [TEST]) LYOPHYLIZED POWDER FOR SUBCUTANEOUS INJECTION VERSUS EU-APPROVED XOLAIR® LYOPHYLIZED POWDER FOR SUBCUTANEOUS INJECTION (REFERENCE) IN HEALTHY SUBJETCS: CIMA STUDY.
This study is comparing a new version of a common medicine, Xolair, with the original. It's looking at how the new medicine works in the body, its safety, and if it causes an immune reaction. This is for healthy people, not those with existing conditions.
Spain