Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU)
Public ClinicalTrials.gov record NCT06162728. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b/2a, Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines and/or Omalizumab, or Who Cannot Tolerate Omalizumab
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06162728
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 87 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 28, 2023
- Primary completion
- Jul 7, 2026
- Completion
- Jul 7, 2026
- Last update posted
- Aug 5, 2026
2023 – 2026
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site 118 | Birmingham | Alabama | 35244 | — |
| Site 108 | Little Rock | Arkansas | 72205 | — |
| Site 105 | San Diego | California | 92123 | — |
| Site 113 | Miami | Florida | 33165 | — |
| Site 116 | Tampa | Florida | 33613 | — |
| Site 109 | Boise | Idaho | 83706 | — |
| Site 124 | Springfield | Illinois | 61761 | — |
| Site 110 | Indianapolis | Indiana | 46250 | — |
| Site 122 | Overland Park | Kansas | 66210 | — |
| Site 123 | Lafayette | Louisiana | 70508 | — |
| Site 101 | Baltimore | Maryland | 21224 | — |
| Site 104 | Chevy Chase | Maryland | 20815 | — |
| Site 121 | White Marsh | Maryland | 21162 | — |
| Site 103 | Cincinnati | Ohio | 45236 | — |
| Site 111 | Murray | Utah | 84107 | — |
| Site 115 | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06162728, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 5, 2026 · Synced Sep 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06162728 live on ClinicalTrials.gov.