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

ConditionsChronic Spontaneous Urticaria (CSU)Chronic Idiopathic Urticaria
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCalixis Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and females 18 through 85 years.

Diagnosis of chronic spontaneous urticaria (CSU) ≥ 6 months.

Active CSU despite treatment with a second-generation H1 antihistamine.

Weekly Urticaria Activity Score (UAS7) ≥ 16 and ISS7 ≥ 8 during the 7 days before randomization, with sufficient electronic diary entries to calculate the baseline scores.

Disqualifiers

Chronic urticaria with an identified cause other than chronic spontaneous urticaria.

Another active skin condition associated with chronic itching that could interfere with the study assessments.

Recent treatment with prohibited immunosuppressive therapy, biologic therapy, a Bruton's tyrosine kinase inhibitor, an investigational drug, or another therapy that inhibits the c-KIT receptor.

Clinically significant hepatic, hematologic, or renal disease or laboratory abnormalities.

Trial design

Design model

Parallel

Treatments tested in this trial

  • THB335 Lower Dose

    Drug

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

  • THB335 Higher Dose

    Drug

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

  • Placebo

    Drug

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

Treatment groups

81 Participants
are divided into 3 treatment groups
Group A: THB335 Higher DoseExperimental treatment 1 intervention
Group B: THB335 Lower DoseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12

UAS7 is the sum of daily Urticaria Activity Scores over 7 days. The daily score combines the Hives Severity Score and Itch Severity Score, each scored from 0 to 3. UAS7 ranges from 0 to 42; higher scores indicate greater disease activity.

Time frame
Baseline and Week 12

Secondary outcomes

1

Percentage of Participants With UAS7 ≤ 6

UAS7 ranges from 0 to 42. UAS7 ≤ 6 represents well-controlled urticaria.

Time frame
Through Week 12
2

Percentage of Participants With UAS7 = 0

UAS7 = 0 indicates no reported hives or itching during the 7-day scoring period.

Time frame
Week 12
3

Change From Baseline in UAS7

UAS7 ranges from 0 to 42.

Time frame
Baseline to Week 8
4

Change From Baseline in Weekly Itch Severity Score (ISS7)

ISS7 is the sum of daily itch-severity scores over 7 days. Daily itch severity is scored from 0 (no itch) to 3 (severe itch); ISS7 ranges from 0 to 21.

Time frame
Baseline to Week 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Calixis Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: