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NCT06162728 · ClinicalTrials.gov registry record · Phase 1

Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU)

A Phase 1 study of Chronic Spontaneous Urticaria, sponsored by Jasper Therapeutics.

Active
Registry status
Phase 1
Development phase
88
Enrollment target
20
Study locations

NCT06162728 is a Phase 1 study of Chronic Spontaneous Urticaria that is active but no longer recruiting, run by Jasper Therapeutics. The registered enrollment target is 88 participants, below the 1,422-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT06162728, a Phase 1 study of Chronic Spontaneous Urticaria, is active but no longer recruiting, sponsored by Jasper Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
88 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Chronic Spontaneous Urticaria

Interventions

  • OTHER Placebo
  • DRUG Briquilimab

Study Locations (20)

Other

  • Site 201 - Berlin
  • Site 211 - Buxtehude
  • Site 209 - Dresden
  • Site 206 - Lübeck

Maryland

  • Site 101 - Baltimore
  • Site 104 - Chevy Chase
  • Site 121 - White Marsh

Florida

  • Site 113 - Miami
  • Site 116 - Tampa

Alabama

  • Site 118 - Birmingham

Arkansas

  • Site 108 - Little Rock

California

  • Site 105 - San Diego

Idaho

  • Site 109 - Boise

Illinois

  • Site 124 - Springfield

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2023-11-29
Est. Completion 2026-10-31
Phase Phase 1

Sponsor

Jasper Therapeutics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06162728

The ClinicalTrials.gov registry entry for NCT06162728 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,422-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (94% lower). The listed sponsor is Jasper Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Spontaneous Urticaria appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06162728 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, Maryland, Florida.

Frequently Asked Questions

What is clinical trial NCT06162728 about?

NCT06162728 is a clinical study titled "Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU)". 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 adul...

What is the current status of trial NCT06162728?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2023-11-29. Estimated completion is 2026-10-31.

What conditions does trial NCT06162728 study?

This clinical trial studies the following conditions: Chronic Spontaneous Urticaria.

What interventions are being tested in trial NCT06162728?

The interventions under investigation include: Placebo (OTHER), Briquilimab (DRUG).

Who is sponsoring clinical trial NCT06162728?

This trial is sponsored by Jasper Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06162728 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.