MedTrace Logo

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)

NCT07766499 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2026-08-14

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Spontaneous Urticaria (CSU)
  • Chronic Idiopathic Urticaria

Interventions

DRUG

THB335 Lower Dose

THB335 is an orally administered capsule added to a stable background regimen of a second generation H1 antihistamine.

DRUG

THB335 Higher Dose

THB335 is an orally administered capsule added to a stable background regimen of a second generation H1 antihistamine.

DRUG

Placebo

Placebo is an orally administered capsule added to a stable background regimen of a second generation H1 antihistamine.

Sponsors & Collaborators

  • Calixis Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-12-31
Completion
2028-01-31
FDA Drug
Yes

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07766499 on ClinicalTrials.gov