A Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activ… (NCT06353971) | Clinical Trial Compass
TerminatedPhase 1/2
A Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment With H1- Antihistamines
Stopped: Enrollment was completed and primary efficacy endpoint was completed. Study was terminated before safety follow up was completed due to changes in company priorities and not related to safety concerns
Germany27 participantsStarted 2024-03-18
Plain-language summary
This is an open-label, single ascending dose Phase 1b/2a trial to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with Cold Urticaria (ColdU) or Symptomatic Dermographism (SD), who remain symptomatic despite treatment with H1 antihistamines. The trial will explore three ascending dose levels which will be tested in three sequential cohorts.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent obtained from potential participants capable of providing 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
✓. Diagnosis of ColdU or SD despite the use of H1-antihistamines as defined by all of the following:
✓. Use of H1-antihistamines on stable dose up to four-fold of the approved dose for at least 4 weeks prior to the Screening visit and not expected to change during first 12 weeks of the trial.
✓. Participants with chronic spontaneous urticaria (CSU) are eligible if they present with symptoms consistent with ColdU or SD and ColdU or SD is the dominant type of chronic urticaria.
✓. Blood counts at Screening with:
✓. Willing and able to participate and adhere to the trial visits schedule.
Exclusion criteria
✕. Women who are pregnant or nursing or intend to become pregnant during the course of the trial
What they're measuring
1
Incidence and severity of treatment emergent AEs/SAEs [safety and tolerability] of a single dose of briquilimab in patients with ColdU or SD who remain symptomatic despite the use of H1 antihistamines.
Timeframe: From signing the informed consent form (ICF) through end of trial (EOT) visit (Week 36)
✕. Participants weighing less than 40 kg or more than 125 kg at Screening
✕. Dominant comorbid chronic urticaria with a clearly defined predominant or sole trigger (chronic inducible urticaria) other than ColdU or SD, including, heat-, solar-, pressure-,delayed pressure-, aquagenic-, cholinergic-, or contact urticaria as well as variants of cold induced urticaria or familial cold autoimmune syndrome except CSU (see inclusion criterion #5)
✕. Other active diseases with possible symptoms of urticaria, wheals or angioedema, including urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
✕. Any other active skin disease associated with chronic itching that might confound the trial evaluations and results in the opinion of the Investigator (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.)
✕. History of severe anaphylaxis as defined by Sampson et al. (Section 25.1 ) within 5 years of Screening
✕. Any H2 antihistamine, leukotriene receptor antagonist or tricyclic antidepressant use within 3 days prior to Screening
✕. Experimental monoclonal antibody therapy (e.g., dupilumab, ligelizumab, etc.) within 6 months or Janus kinase (JAK) inhibitors or experimental Bruton Tyrosine Kinase (BTK) inhibitors within 5 half-lives prior injection of IP