A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)

ClinicalTrials.gov ID: NCT07766499

Public ClinicalTrials.gov record NCT07766499. 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.

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ClinicalTrials.gov public records Last synced Nov 3, 2026, 12:33 PM EST

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Official title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy and Safety of THB335 in Adult Participants With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Standard-of-Care Treatment

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

THB335-201 is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adults with CSU who remain symptomatic despite standard-of-care treatment. The study includes a Screening Period of up to 4 weeks, a 12-week Treatment Period, and a 4-week Follow-Up Period, for a total participant duration of approximately 20 weeks.

Study identification

NCT ID: NCT07766499
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Calixis Inc.; Industry
Enrollment: 81 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 85 Years
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: Sep 15, 2026 (Actual)
Primary completion: Dec 31, 2027 (Estimated)
Completion: Jan 31, 2028 (Estimated)
Last update posted: Nov 2, 2026

2026 – 2028

United States locations

U.S. sites: 15
U.S. states: 10
U.S. cities: 15

Facility	City	State	ZIP	Site status
Calixis Study Site	Pasadena	California	91106	Recruiting
Calixis Study Site	Ventura	California	93003	Recruiting
Calixis Study Site	Walnut Creek	California	94596	Recruiting
Calixis Study Site	Altamonte Springs	Florida	32701	Recruiting
Calixis Study Site	Tampa	Florida	33607	Recruiting
Calixis Study Site	Atlanta	Georgia	30329	Recruiting
Calixis Study Site	Boise	Idaho	83706	Recruiting
Calixis Study Site	Baton Rouge	Louisiana	70809	Recruiting
Calixis Study Site	White Marsh	Maryland	21162	Recruiting
Calixis Study Site	Wildwood	Missouri	63040	Recruiting
Calixis Study Site	Asheville	North Carolina	28803	Recruiting
Calixis Study Site	Smyrna	Tennessee	37167	Recruiting
Calixis Study Site	Austin	Texas	78726	Recruiting
Calixis Study Site	Houston	Texas	77082	Recruiting
Calixis Study Site	Prosper	Texas	75078	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07766499, 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 Nov 2, 2026 · Synced Nov 3, 2026

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The complete public registry record, listed eligibility criteria, and available contact information for NCT07766499 live on ClinicalTrials.gov.

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