Status and phase
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About
This trial will be performed as a three-part dose escalating clinical trial where Parts 1 is open label and Parts 2 and 3 are randomized, double-blinded, and placebo-controlled.
The trial is intended to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with chronic spontaneous urticaria (CSU), who remain symptomatic despite treatment with H1 antihistamines and omalizumab. Additionally, pharmacokinetic (PK) properties of briquilimab, and other pharmacodynamic (PD) parameters (such as effects on mast cells (MC), serum tryptase levels, and on allergic skin reactivity) will be investigated.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Written informed consent after the nature of the trial has been fully explained and before performing any trial related assessments
Males and females, ≥18 years old
i. For Cohorts 1, 2, 3, 4a, 4b, 5, 5b, 6 and 7: Diagnosis of symptomatic CSU despite treatment as defined by:
ii. For Cohorts 8 and 9: Diagnosis of symptomatic CSU despite treatment as defined by:
Use of H1-antihistamines on stable dose up to four-fold of the approved dose since Screening and not expected to change during first 12 weeks of the trial
Blood counts at Screening with:
Willing and able to complete a daily diary for the duration of the trial and adhere to the trial visit schedule
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
80 participants in 2 patient groups, including a placebo group
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Central trial contact
Medical Director
Data sourced from clinicaltrials.gov
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